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Skin-derived fibroblasts may be safe for treating Achilles tendinosis.

Thursday, February 16th, 2012

Abstract

Background:Chronic Achilles tendinosis is a common musculoskeletal disorder often refractory to conservative management. Our study aimed to assess the safety and efficacy of the use of autologous skin-derived collagen-producing cells in the treatment of refractory Achilles tendinosis.

Methods:We conducted a randomized, double-blind study on forty Achilles tendons in thirty-two patients (eight with bilateral involvement) who had a clinical and radiographic diagnosis of Achilles tendinosis. The patients ranged from twenty-two to sixty-seven years old and had a mean age of 45.2 years. The patients with unilateral involvement were randomized into the treatment group (twelve patients) and control group (twelve patients). The eight patients with bilateral involvement were individually randomized into treatment and control groups, with eight Achilles tendons in each group. Achilles tendons in the treatment group were injected under ultrasound guidance with laboratory-expanded, skin-derived fibroblasts suspended in autologous plasma. The control group received ultrasound-guided injection of a local anesthetic and physiotherapy. The Victorian Institute of Sport Assessment (VISA) questionnaire and visual analog scale (VAS) scores were used as the main outcome measures for both groups.

Results:Significant differences in the mean VISA and VAS scores were detected between the treatment and the control groups for the patients with unilateral involvement at six months (p < 0.001 for both). With use of the Mann-Whitney U Test, significant differences in the VISA score were observed at the second visit and at the three-month and six-month visits (p = 0.02, p = 0.007, and p < 0.001 respectively). The VAS scores also showed significant differences at the second visit and at the six-month evaluation (p = 0.014 and p < 0.001, respectively). The eight patients with bilateral involvement were analyzed separately; with the number of patients studied, no significant differences in the VISA or VAS scores were observed between the treatment group and the control group.

Conclusions:These preliminary short-term results demonstrate that the injection of skin-derived fibroblasts for the treatment of Achilles tendinosis is safe. However, larger studies with a longer duration of follow-up are required to determine the long-term effectiveness before wider clinical application is considered.

 

 

Studies support use of viscosupplementation in knees with OA

Thursday, February 16th, 2012

Session: 18-Practice Management/Rehabilitation I Date/Time: Wednesday, Feb 08, 2012, 2:06 PM – 2:12 PM Presentation Number: 261 Title: The Effects of Viscosupplementation on Knee Proprioception in Early Stage Osteoarthritis Osteoporotic Patients Classification: Rehabilitative Medicine Keywords: Viscosupplement; Knee / Hip / Osteoarthritis / Total Hip Arthroplasty; Outcomes; Osteoporosis Author(s): Francesco Pegreffi, MD, PhD, Bologna, Italy
Paolo Pegreffi, MD, Suzzara, Minnesota, Italy
Abstract: INTRODUCTIONA critical appraisal of the current evidence-based research offers no guidance in the treatment of early stages of knee arthritis disability in the elderly population. Furthermore, the progressive loss of the cartilage integrity compromises function of the diseased knee during everyday activities, resulting in different biomechanical strategies to compensate for the uncontrolled balance, thus favoring falls and fragility fractures. The purpose of this study was to analyze hyaluronic acid (HA) effects exerted in terms of pain relief and consequently improved balance in osteoporotic elderly patients affected by early stage knee osteoarthritis.
METHODSSixty low-bone-density patients affected by knee osteoarthritis (stage 1), were randomly divided into two groups to respectively receive HA injection (Group A: 30) or not (Group B: 30). Inclusion criteria were: age > 65 years, good general health and cognitive status, early stage arthritis (confirmed by x-rays), normal or controlled blood pressure, no eye and/or ear problems, low-bone density at bone mineral density (BMD). VAS, satisfaction index and stabilometric pattern were evaluated before and after five injections of HA.
RESULTSIn Group A, VAS significantly reduced after HA injection (p<0.005). Furthermore, stabilometric parameters were significantly affected in terms of weight distribution (p<0.05) and center of balance (p<0.05).
DISCUSSION AND CONCLUSIONEven if osteoarthritis progression can’t be stopped, reducing pain in short term, and globally improving balance, can significantly affect quality of life, reduce risk of falls and related-fragility fracture consequences.

 

Session: 18-Practice Management/Rehabilitation I Date/Time: Wednesday, Feb 08, 2012, 1:54 PM – 2:00 PM Presentation Number: 259 Title: Long Term Management of Knee Osteoarthritis with Hylan GF-20: Efficacy, Safety of Repeat Treatments Over Four Years Classification: Rehabilitative Medicine Keywords: Viscosupplement; Outcomes Author(s): Raghu Raman, MRCS, Swanland, United Kingdom
Arup Dutta, FRCS, -, Illinois, United States
Geoffrey V. Johnson, FRCS, Hull, United Kingdom
Christopher Shaw, FRCS, United States
Nicky Day, rosemont, Illinois, United States
Abstract: INTRODUCTION
Osteoarthritis (OA) is a chronic disease and its management is a constant process. Pain and symptom relief from viscosupplementation is variable ranging from three to 12 months necessitating repeat courses of treatment. The aim of this study was to assess the safety and efficacy of multiple repeat intra-articular injections of hylan GF-20 in the treatment of osteoarthritis of the knee
METHODS
Patients with OA of the knee were offered initial treatment with hylan GF-20 and repeat courses after a minimum of six months from the previous injection(s). The inclusion criteria was pain score of >6 on a VAS (0-10) in the target knee. Patients with at least two treatment courses were included in the study. This is a prospective, longitudinal independent study over six years in the same institution, where all patients were reviewed by blinded assessors at pre injection, one week, six weeks, three months, six months after every treatment course. The primary outcome variable was knee pain on VAS at six months. Secondary outcome measures were WOMAC, Oxford knee score and SF-12. All adverse events (AE) were recorded.
RESULTS
From our arthritis database, we identified 1,103 patients who had repeat treatments (two to eight courses, median-three) with hylan GF-20. The mean time to repeat treatment was 45.6 weeks (27-104,weeks). Knee pain on VAS improved from 6.6 to 3.7 at six months (p=0.02) over all courses. Mean improvement in knee pain was 51% after the first repeat course and 49% at the last repeat course. Significant improvements from the baseline in the WOMAC pain and function subscales and Oxford knee scores were observed during all repeat courses. Overall incidence of AE was 13.4% (11.9% in initial course) from the pooled data. The incidence of AE had no correlation to the number of repeat treatments.
DISCUSSION AND CONCLUSION
Pain relief and improvement of function are consistently observed following repeat treatment of symptomatic OA of the knee with hylan G-F 20. Longevity and magnitude of symptom control are similar to the first course of treatment. Repeat courses are well tolerated with low adverse events. This study demonstrates that viscosupplementation with hylan GF-20 is an invaluable tool in the multimodal treatment and forms part of the armamentarium of OA management

 

Session: 18-Practice Management/Rehabilitation I Date/Time: Wednesday, Feb 08, 2012, 2:30 PM – 2:36 PM Presentation Number: 264 Title: Safety, Efficacy and Outcome of 4,400 Patients Treated with Viscosupplementation for Osteoarthritis of Knee Classification: Rehabilitative Medicine Keywords: Viscosupplement; Knee / Hip / Osteoarthritis / Total Hip Arthroplasty; Rehabilitation Author(s): Raghu Raman, MRCS, Swanland, United Kingdom
Rohit Rambani, MS, Sheffield, United Kingdom
Geoffrey V. Johnson, FRCS, Hull, United Kingdom
Christopher Shaw, FRCS, United States
Jagwant Singh, MRCS, Colchester, United Kingdom
Nicky Day, rosemont, Illinois, United States
Abstract: INTRODUCTION
Viscosupplementation is used widely to provide symptomatic relief to patients with knee osteoarthritis (OA). This study is aimed to assess the safety, analgesic efficacy and functional outcome of hylan GF-20 in a large cohort of patients.
METHODS
This is an independent, prospective, blinded (reviewers), longitudinal cohort study over six years in a single instituton. Inclusion criteria was OA knee pain of at least 60mm on a 100mm VAS; no prior intra articular (IA) injection. Patients received 3 x 2mL hylan G-F 20 or 1 x 6mL (from 2009). Follow up at one, six, 12 and 26 weeks by blinded reviewers. Analgesics prohibited for 24 hours prior to follow-up assessments and NSAIDs for 26 weeks. All adverse events (AE) were recorded. Primary outcome measure: target knee pain (VAS) at 26 weeks. Secondary outcome measures included WOMAC, Oxford knee score, SF12, Euroqol Eq 5D.
RESULTS
A total of 4,400 patients were recruited from 2004-2010. All patients received hylan GF-20 (3 x 2 mL N=3352, 1 x 6mL N=1048). Mean age was 61.2 yrs and 71% had Grade III (K-L) disease. Injection and/ or treatment-related AE in the target knee were reported in 11.2% (3 x 2 mL) and 9.8% (1 x 6 mL) of patients. Significant pain reduction (>40%) was observed in both groups at 26 weeks (3 x 2 mL: 57% (mean) decrease from baseline, 1 x 6mL: 51%). Overall knee pain on VAS improved from 69 to 37 at six months (p=0.02). Significant improvements from the baseline in the WOMAC pain and function subscales (65% improvement at 26 weeks) and Oxford knee scores at three and six months were observed. There were no significant differences between groups in demographics or for any of the primary or secondary outcome measures at 26 weeks.
DISCUSSION AND CONCLUSION
Viscosupplementation with hylan GF-20 is an efficacious and safe treatment option for patients with symptomatic OA of knees. Pain relief lasts for at least six months after a first course of treatment. Single dose of 6 mL hylan G-F 20 offers comparable safety and efficacy to 3 x 2 mL at 26 weeks. It provides both the patients and physicians a choice with the potential additional benefits of reduced operational costs.

 

Smokers have higher TKA revision rates

Thursday, February 16th, 2012

 

Session: ARK Posters-Adult Reconstruction Knee Posters
Date/Time: Tuesday, Feb 07, 2012, 8:00 AM – 6:00 PM
Poster Hall/ Multimedia/ Scientific Exhibits: Tuesday, Feb 7 – Saturday, Feb 11, 2012, 8:00 AM – 6:00 PM
Presentation Number: P198
Posterboard Number: P198
Title: Increased Revision Rates Following Total Knee Arthroplasty in Patients Who Smoke
Classification: Adult Reconstruction Knee
Keywords: Revision Total Knee Arthroplasty; Miscellaneous; Total Knee Arthroplasty General Outcome
Author(s): Aaron J. Johnson, MD, Baltimore, Maryland, United States
Qais Naziri, MD, Baltimore, Maryland, United States
Michael A. Mont, MD, Baltimore, Maryland, United States
Ronald E. Delanois, MD, Baltimore, Maryland, United States
Peter M. Bonutti, MD, Effingham, Illinois, United States
Abstract: INTRODUCTIONBecause of the vasoconstrictive effect that tobacco use has on the vasculature, patients may have decreased healing potential. Historically, smoking has been associated with delayed time to fracture callus formation, increased non-union and mal-union in orthopaedic cases, as well as increased incidences of soft-tissue complications and skin necrosis after any surgical procedure. All patients are encouraged to stop or decrease their tobacco use during the peri-operative period; however, patients are rarely compliant with this request. The purpose of this study was to compare the clinical outcomes of total knee arthroplasty (TKA) in patients who are, or were smokers, to outcomes in the patients operated on during the same time period who were not smokers.
METHODSA review of all total knee arthroplasties performed at two high-volume centers in patients who had indicated tobacco use on their intake history and physical at the time of surgery. Between 2005 and 2009, there were 127 TKAs performed in patients who were smokers, and 471 knees in patients who did not smoke. There were 54 men and 61 women who were smokers; they had a mean age of 55 years (range, 35 to 84 years), a mean body mass index of 33 kg/m2 (range, 18 to 53 kg/m2), and a mean follow up of 46 months (range, 24 to 72 months). All patients who were smokers were encouraged to participate in some form of smoking cessation program during the peri-operative period. Patients were stratified according to their total tobacco history, and their current status of use. Cigarettes were assumed to contain 1 gram of tobacco, and cigars 6 grams. Pack-year history was calculated by multiplying the daily total mass of tobacco by the length of time the patient reported smoking, and dividing by 20 (the number of cigarettes per pack). Patients were stratified into less than 20 pack-year history, 21 to 40 pack years, and greater than a 40 pack-year history of tobacco use. Additionally, their current smoking status was divided between “smoker” and “former smoker.” Clinical outcomes as measured using the Knee Society pain and function scores, as well as range of motion, were compared between the two groups.
RESULTSAt a mean most recent follow up the patients who were smokers had an overall survivorship of 91% (12 revisions), compared to 17 aseptic failures in the non-smokers (96%; p=0.01) in the non-smokers (p=0.01). The Knee Society objective and function scores in the patients who smoked were a mean 91 points (range, 56 to 100 points) and 89 points (range, 45 to 100 points), respectively. Of the 12 revisions, there were nine aseptic revisions (one for periprosthetic fracture, two for instability, six for pain and component loosening) and three infections (one treated with irigation and debridement, and two treated with staged revision arthroplasty). All patients except one were doing well at most recent follow up (Knee Society scores > 80 points); the remaining patient required re-revision. Additionally, in the smoking cohort there was one peroneal nerve palsy, and one compartment syndrome (both did well after surgical releases).
DISCUSSION AND CONCLUSIONTobacco and nicotine use is known to be vasoconstrictive, and as such can lead to increased healing times. This has the potential to lead to worse results for patients who are undergoing total knee arthroplasty. Despite encouraging smoking cessation, most patients who are smokers were non-compliant with this request. The results of our study indicate that patients who smoke had a higher overall revision rate and a higher incidence of other complications. Given these results, it is the opinion of the senior authors that all efforts be taken to get patients to stop or minimize any nicotine use prior to total knee arthroplasty.

 

 

Smoking is a significant risk factor for early failure in complex primary and revision THA.

Thursday, February 16th, 2012

Session: 15-Adult Reconstruction Hip II Date/Time: Wednesday, Feb 08, 2012, 12:06 PM -12:12 PM Presentation Number: 223 Title: Smoking is a Harbinger of Early Failure with Ultraporous Metal Acetabular Reconstruction Classification: Adult Reconstruction Hip Keywords: Revision / Acetabular Component; Primary Total Hip Arthroplasty Cementless; Miscellaneous; Complications; Total Hip Arthroplasty Author(s): Adolph V. Lombardi, Jr, MD, New Albany, Ohio, United States
Keith R. Berend, MD, New Albany, Ohio, United States
Michael J. Morris, MD, New Albany, Ohio, United States
Joanne B. Adams, BFA, CMI, New Albany, Ohio, United States
Michael A. Sneller, BS, New Albany, Ohio, United States
Tawnya Tucker, MT, New Albany, Ohio, United States
Abstract: INTRODUCTION
Acetabular reconstruction with newer ultraporous metal in both complex primary and revision total hip arthroplasty (THA) has increased survivorship with stable fixation and few failures. Smoking is considered a risk factor for surgical complications including transfusion, infection and cardiac. We hypothesized that the early results of ultraporous metal acetabular reconstruction would be unaffected by smoking in complex primary and revision THA.
METHODS
Between 1999 and 2009, ultraporous acetabular components were used in 535 hips (500 patients) for 160 complex primary and 375 revision cases. Of these patients 17% were smokers, 29.5% previous smokers, 49.0% non-smokers and 4.5% unknown. Early failures possibly related to negative effects of smoking were considered any infection, failure of in-growth or periacetabular fracture. Failures not considered related to smoking included dislocation and implant breakage.
RESULTS
There were 33 failures at an average of 18 months post-operative for a failure rate of 6.2%: 15 infections, 13 failure of ingrowth, three dislocations, and one each liner fracture and periacetabular fracture. The failure rate in smokers was 11%, in non-smokers 3.8%, and in previous smokers 5.3% (Pearson’s 6.5; p=0.01). With only smoking related failures included, the rate was 9% in smokers and 3.6% in non-smokers (4.6; p=0.03). With previous smokers included as smokers failure is 9.2% (6.2; p=0.01) and included as non-smokers 5.8% (3.7; p=0.05).
DISCUSSION AND CONCLUSION
Even with ultraporous metal technology, smoking is a significant risk factor for early failure in complex primary and revision THA. Quitting smoking reduces the inherent risk. Smoking cessation should be considered during pre-operative education.

 

PRP offers longer lasting improvement for chronic plantar fasciitis

Thursday, February 16th, 2012

 

Session: 4-Foot and Ankle I
Date/Time: Tuesday, Feb 07, 2012, 11:06 AM -11:12 AM
Presentation Number: 051
Title: Platelet-Rich Rich Plasma is More Effective than Cortisone for Chronic Severe Plantar Fasciitis
Classification: Foot/Ankle
Keywords: Plantar Fasciitis; Foot / Ankle
Author(s): Raymond R. Monto, MD, Nantucket, Massachusetts, United States
Abstract: INTRODUCTION
Chronic plantar fasciitis is a common but sometimes difficult condition to successfully treat. Platelet rich plasma (PRP), a concentrated bioactive component of autologous blood that is rich in cytokines and other growth factors, was compared with cortisone injection in the treatment of severe cases of plantar fasciitis resistant to traditional non-operative paradigms.
METHODS
Thirty-six patients (16 males, 20 females) with severe chronic plantar fasciitis who had failed traditional non-operative treatment (rest, heel lifts, PT, NSAIDS, cam walker immobilization, night splinting, local modalities) were randomized into two study groups and evaluated prospectively. All patients had pre-treatment MRI and ultrasound studies consistent with plantar fasciitis. Group 1 was treated with a single ultrasound-guided injection of 40 mg methylprednisolone at the injury site and Group 2 was treated with a single ultrasound-guided injection of un-buffered autologous PRP at the injury site. All patients were then immobilized fully weight bearing in a cam walker for two weeks, started on eccentric home exercises and then allowed to return to normal activities as tolerated and without support.
RESULTS
Group 1 had an average age of 59 (24-74) and had failed 5.4 months (4-24) of standard non-operative management and had pre-treatment AOFAS scores of 52 (24-60). The PRP group had an average age of 51 (21-67) and had failed 5.7 months (4-26) of standard non-operative management and had pre-treatment AOFAS scores of 37 (30-56). Post-treatment AOFAS scores in Group 1 initially improved to 81 (60-90) at three months but decreased to 74 (56-85) at six months and dropped further to 58 (45-77) at 12 months follow up. Post-treatment AOFAS scores in Group 2 improved to 95 (84-90) at three months and remained excellent at 94 (87-100) at six months and stayed at 94 (86-100) at 12 months follow up (CI 95% P=0.001). No patients were lost to follow up.
DISCUSSION AND CONCLUSION
This study suggests that platelet rich plasma injection is significantly more effective and durable than cortisone injection for the treatment of severe chronic plantar fasciitis refractory to traditional non-operative management.

 

 

Neuromuscular training may help prevent ACL injuries.

Thursday, February 16th, 2012

Session: 7-Sports Medicine/Arthroscopy I
Date/Time: Tuesday, Feb 07, 2012, 4:30 PM – 4:36 PM
Presentation Number: 095
Title: A Randomized Trial of Anterior Cruciate Ligament Injury Prevention in Adolescent Female Soccer
Classification: Sports Medicine/Arthroscopy
Keywords: Injuries; ACL Deficient; Research / Clinical
Author(s): Markus Walden, MD, PhD, Kristianstad, Sweden Isam Atroshi, MD, Kristianstad, Sweden Henrik Magnusson, MSc, Linköping, Sweden Philippe Wagner, MSc, Lund, Sweden Martin Hagglund, PhD, Linkoping, Sweden
Abstract: INTRODUCTION
In the United States there are more than three million youth soccer players with nearly half of them females. Unfortunately, knee injuries are common, but there is limited evidence on the preventive effect of neuromuscular training.
METHODS
The study is a two-armed parallel-group cluster randomized trial where female soccer players aged 12-17 years in 309 clubs in Sweden were cluster randomized into an intervention group (n=154) or a control group (n=155). The intervention group was instructed to complete a 15-minute neuromuscular warm-up program, consisting of six exercises focusing on knee control and core stability, twice a week throughout the 2009 season. Each exercise is subdivided into four steps of progressing difficulty and a pair-exercise. Coaches documented individual player exposure during the season, and acute knee injuries were examined by physical therapists and physicians assigned to the clubs. The primary outcome was anterior cruciate ligament (ACL) injury rate and secondary outcomes were rates of severe knee injury (lay-off > four weeks) and any acute knee injury.
RESULTS
In total, 121 intervention clubs (2,479 players) and 109 control clubs (2,085 players) were included for analysis. Unadjusted Cox regression according to intention-to-treat showed a 64% reduction of ACL injury rate in the intervention group (hazard ratio 0.36, 95% confidence interval 0.14 to 0.90, P=0.03), but no significant effect for secondary outcomes. Per-protocol analyses of compliant players, carrying out minimum one exercise session per week, showed preventive effects for ACL injury (HR 0.14, 95% CI 0.04 to 0.50, P=0.003), severe knee injury (HR 0.20, 95% CI 0.08 to 0.55, P=0.001), and acute knee injury (HR 0.53, 95% CI 0.31 to 0.95, P=0.03).
DISCUSSION AND CONCLUSION
A 15-minute neuromuscular warm-up program significantly reduced the ACL injury rate in adolescent female soccer. Compliant players also had significant decrease in rates of severe knee injury and any acute knee injury.

 

 

Bearings symposium features international points of view

Thursday, February 16th, 2012

Maureen Leahy

Millions of individuals are living full and active lives thanks to joint replacement. Recent attempts to improve bearing surfaces, however, can lead to problems such as increased friction and joint wear.

On Tuesday, leading international experts discussed the current state of alternate bearings—ceramic-on-ceramic (CoC), metal-on-metal (MoM), and highly cross-linked polyethylene—for total hip arthroplasty during the “Worldwide Perspective on Alternate Bearings” symposium, moderated by Henrik Malchau, MD, of Massachusetts General Hospital in Boston.

All bearings fail
Wear debris–related failure is associated with MoM implants, according to William L. Walter, MD, PhD, of Sydney, Australia. He conducted a retrieval analysis on 55 CoC total hip arthroplasty (THA) and 17 MoM THA patients with similar demographics.

“We did not see any wear debris–related failures in the CoC cohort. The median rate of wear was greater for MoM than for CoC, but it is the outliers in MoM than tend to be much greater than CoC in terms of wear debris. We believe this is due to a difference in biologic activity where metals are much more toxic to tissues than ceramics,” he said.

Dr. Walter added that although posterior edge loading is common in CoC, it is clinically benign. On the other hand, anterosuperior edge loading is less common, but produces more wear and may be associated with problematic squeaking.

“All bearings can and do fail,” added John Skinner, FRCS, of London, United Kingdom. “But the problems that we began seeing with metal bearings—necrosis and tissue damage—were something new. We’re now looking at who to revise and how to follow-up on MoM patients.”

Symptoms such as pain and limp are very important in diagnosing adverse reactions to MoM implants; therefore, follow-up must be clinical, according to Dr. Skinner. Blood tests that measure metal ions level are also helpful, as is cross-sectional imaging.

“Some surgeons are reluctant to perform hip resurfacing procedures due to all the concern about MoM implants, yet these procedures can still produce excellent results,” he said. “However, I don’t believe we should be performing large-diameter MoM total hip replacements.”

Edge loading has been suggested to increase wear in MoM THA, and abnormal periprosthetic soft-tissue masses (pseudotumors) have been associated with elevated metal ion levels in serum and hip aspirate. These associations led to two studies by Young-Min Kwon, MD, PhD, of Massachusetts General Hospital. The first study quantified in vivo wear of implants revised for pseudotumors and a control group of implants revised for other reasons; the follow-up study investigated in vivo edge loading during functional activities in patients with pseudotumors.

Results showed that the MoM implants revised due to pseudotumor had significantly greater linear wear rates. Patients with pseudotumors also had elevated in vivo metal ion concentrations, confirming that pseudotumors are associated with increased wear at the MoM articulation. In addition, edge loading in MoM THA patients with pseudo-tumors occurred with significantly longer duration and greater magnitude of force impulse compared with patients with a well-functioning MoM implant.

This supports the hypothesis that edge loading is an important mechanism leading to localized high wear, with subsequent elevation of metal ion levels in MoM patients with pseudotumors. Dr. Kwon also noted that, although the acetabular component orientation appears to be an important factor in edge loading, the etiology of edge loading is likely to be multifactorial.

Polyethylene bearing surfaces
Highly cross-linked polyethylene THA cups show reduced wear at 10-year follow-up compared to conventional polyethylene cups, according to radiostereometric analysis (RSA) study data presented by Johan N. Kärrholm, MD, of Sweden. RSA involves taking two radiographs from different directions at the same time, thus creating a “stereo” image that enables surgeons to measure precisely how the body and the implant are interacting.

The study involved 60 osteoarthritic patients (30 females, 30 males; median age: 55 years) who were randomized to receive either highly cross-linked or conventional polyethylene cups. All implants had cemented stems and 28-mm CoCr heads. RSA examinations, radiographs, dual-energy x-ray absorptiometry (DXA) scans, and clinical examinations were performed at regular intervals for up to 10 years. Measurements of proximal wear and proximal migration of the cup and distal stem migration measurements were compared in the 47 patients (21 highly cross-linked, 26 control) who were followed for the entire study period.

After the 6-month follow-up, the proximal penetration increased mainly in the control group, resulting in a mean difference of 0.45 mm at 10 years (P < 0.0005). The mean proximal cup migration in the cross-linked group was 0.1 mm, compared to 0.3 mm in the control group (P = 0.6); the stem subsidence in the cross-linked group was –0.2, compared to –0.5 in the control group (P = 0.001). Based on these results, the researchers concluded that highly cross-linked polyethylene reduced wear, but did not significantly influence cup and stem migration.

In reviewing long-term wear data for highly cross-linked polyethylene as it relates to age and activity level, Charles R. Bragdon, PhD, and his colleagues at Massachusetts General Hospital identified 187 patients with greater than 5-year follow-up and UCLA activity scores. Patients were grouped according to age at the time of surgery (younger or older than 60 years), low (UCLA scores 1-6) or high (UCLA scores 7-10) activity levels, and standard (28 mm to 32 mm) or large (36 mm to 40 mm) femoral head sizes.

The researchers used Martell Hip Analysis to view two-dimensional measurements of the femoral head penetration.

“We found an extremely low femoral head penetration rate regardless of age, activity level, or femoral head size—we could not detect any increase in wear in any of these subgroups,” said Dr. Bragdon. “With metal-on–highly cross-linked polyethylene, it appears that the limiting factor for longevity of these reconstructions will no longer be concerns of wear. However, younger joint replacement patients will continue to challenge the component fixation as well as the modular interfaces of these modern implants.”

“When polyethylene is subjected to radiation for cross-linking to reduce wear resistance, free radicals are formed throughout the material. And when free radicals are present, the material degrades even when just sitting on the shelf before it is implanted in the patient,” said Orhun Muratoglu, PhD, of Massachusetts General Hospital.

Annealing, melting, or doping with antioxidants, such as vitamin E, can be used to stabilize the material. To determine the effectiveness of these methods, Dr. Muratoglu and his colleagues analyzed in vivo oxidation of surgical retrievals that were irradiated and melted (n = 44), irradiated and annealed (n = 14), sequentially irradiated and annealed (n = 27), and irradiated and vitamin E–stabilized (n = 10).

“Our analysis revealed that annealing is not necessarily desirable because it leaves behind residual free radicals, resulting in high levels of in vivo oxidation and ex vivo oxidation,” said Dr. Muratoglu. “Melting results in very low oxidation up to 10 years, but we did see some ex vivo oxidation, which we think is related to lipids absorbed in vivo and/or cyclic loading. In contrast, vitamin E stabilization showed little oxidation; it appears the free-radical scavenging activity of vitamin E is a very effective in preventing both in vivo and ex vivo oxidation.”

The value of arthroplasty registries
“Assessing the outcome of bearing surfaces is difficult,” said Australian Steven Graves, MD. “Registry data are valuable because they provide reliable information on the comparative performance of different bearing surfaces.”

For example, 10-year data from the Australian Orthopaedic Association National Joint Replacement Registry reveal the following:

  • the lowest rate of revision occurs when a cross-linked polyethylene bearing is used
  • the highest rate of revision occurs when a large (36 mm or larger) MoM head is used, due to an increased incidence of loosening and metal sensitivity
  • cross-linked polyethylene has a significantly lower rate of revision at 10 years compared to non-modified polyethylene, whether the femoral head is metal or ceramic
  • CoC has a higher rate of revision compared to cross-linked polyethylene when a ceramic head of 28 mm or less is used. There is no difference between cross-linked polyethylene and CoC bearings when ceramic heads greater than 28 mm are used.

Disclosures: Dr. Walter—Stryker; DePuy, a Johnson & Johnson Co.; Smith & Nephew; Matortho; Dr. Skinner—London Implant Research Centre for Recalled ASR Implant Analysis; Biomet; DePuy, a Johnson & Johnson Co.; Mathys Ltd.; Smith & Nephew; Zimmer; Stryker; Finsbury; Dr. Kwon—MAKO Surgical Inc.; Dr. Kärrholm—Stryker; Link Orthopaedics; RSA Biometica; Umea; Zimmer, Biomet, DePuy, a Johnson & Johnson Co.; Dr. Bragdon—Zimmer; Dr. Graves—no conflicts; Dr. Muratoglu—Biomet; Zimmer; Corin USA; ConforMIS; Renovis; Cambridge Polymer Group; Johnson & Johnson; MAKO Surgical Inc.; DePuy.

2012 Annual Meeting News

 

 

What is the proper interval for osteoporosis testing?

Tuesday, January 24th, 2012

Bone loss and osteoporosis develop so slowly in most women whose bones test normal at age 65 that many can safely wait as long as 15 years before having a second bone density test, researchers report in a new study.

The study, published in Thursday’s issue of The New England Journal of Medicine, is part of a broad rethinking of how to diagnose and treat the potentially debilitating bone disease that can lead to broken hips and collapsing spines.

A class of drugs, bisphosphonates, which includes Fosamax, has been found to prevent fractures in people with osteoporosis. But medical experts no longer recommend the medicines to prevent osteoporosis itself. They no longer want women to take them indefinitely, and no longer consider bone density measurements the sole defining factor in deciding if a woman needs to be treated.

Now, with the new study, researchers are asking whether frequent bone density measurements even make sense for the majority of older women whose bone density is not near a danger zone on initial tests, recommended at age 65.

“Bone density testing has been oversold,” said Steven Cummings, the study’s principal investigator and an emeritus professor of medical epidemiology and biostatistics at the University of California, San Francisco.

The study followed nearly 5,000 women ages 67 and older for more than a decade. The women had a bone density test when they entered the study and did not have osteoporosis. (In a separate national study by the Centers for Disease Control and Prevention, about 70 percent of women over age 65 did not have osteoporosis.)

The researchers report that fewer than 1 percent of women with normal bone density when they entered the study, and fewer than 5 percent with mildly low bone density, developed osteoporosis in the ensuing 15 years. But of those with substantially low bone density at the study’s start, close to the cutoff point for osteoporosis of fewer than 2.5 standard deviations from the reference level, 10 percent progressed to osteoporosis in about a year.

Dr. Margaret Gourlay, the study’s lead author and a family practice specialist and osteoporosis researcher at the University of North Carolina, said she and her colleagues were surprised by how slowly osteoporosis progressed in women.

Medicare pays for a bone density test every two years and many doctors have assumed that is the ideal interval, although national guidelines recommend them only at “regular intervals.”

“I think this will change the way doctors think about screening,” Dr. Gourlay said.

The results, said Joan A. McGowan, director of the division of musculoskeletal diseases at the National Institute of Arthritis and Musculoskeletal and Skin Diseases, “provide telling evidence that you are not going to fall off a cliff if you have normal bone density in your 60s or early 70s, that you are not going to have osteoporosis in the next five years unless something else happens.”

For example, said Dr. McGowan, who was not involved in the study, a woman who had to take high doses of corticosteroids for another medical condition would lose bone rapidly. But the findings “cover most normal women,” she said.

Bone density screening took off after Fosamax, the first bisphosphonate, was approved at the end of 1995. For the first time, doctors had a specific treatment that had been shown to prevent fractures in people with osteoporosis.

For years doctors were overly enthusiastic, prescribing it for women whose bone density was lower than normal but not in a danger zone, keeping women on the drug indefinitely. They even gave a name, osteopenia, to lower than normal bone density, although it was not clear it had real clinical significance.

Now, osteoporosis experts consider osteopenia to be a risk factor, not a disease, and its importance varies depending on a patient’s age, said Dr. Ethel S. Siris, an osteoporosis researcher at Columbia University who was not involved in the study.

Doctors are more likely to prescribe bisphosphonates for older patients and recommend against them for most younger postmenopausal women with osteopenia.

The experts also generally recommend that most people on bisphosphonates take them for just five years at a time, followed by a drug holiday of undetermined length. The idea is to reduce the risk of rare but serious side effects, including unusual thighbone fractures and loss of bone in the jaw.

A risk calculator, FRAX, can help determine whether treatment is recommended. It assesses a combination of risk factors: whether a parent has had a hip fracture, the age of the patient, steroid use, bone density at the hip, and whether the person has broken a bone after age 50, an especially important indicator. Nearly half who break a hip already had already broken another bone, Dr. Siris said.

“If you are an older individual, a man or a woman, who already broke a major bone — spine, hip, shoulder, or pelvis or wrist — take it very seriously and get treated,” she said. “If you have relatively good bone density then you are not at risk now.”

This article has been revised to reflect the following correction:

Correction: January 20, 2012

By GINA KOLATA/New York Times

 

A headline on Thursday with an article about a finding that bone density tests for osteoporosis can be delayed in women whose bones have already tested normal misstated the researchers’ conclusions. As the article correctly noted, the study included only women who did not have osteoporosis at the outset, and those who developed osteoporosis did not undergo further screenings; the study did not suggest that osteoporosis patients could delay further tests.

 

 

How common is VTE after arthroplasty?

Tuesday, January 24th, 2012

(HealthDay News) — One of every 100 people undergoing knee replacement surgery and 1 of 200 people having hip replacement surgery will develop a blood clot before they leave the hospital, even if they take steps to prevent the development of these blood clots, a new evidence review suggests.

A deep venous thrombosis (DVT) or blood clot can form deep within the veins, usually in the leg. The real risk occurs if these blood clots dislodge, travel through your bloodstream, and block blood flow in your lungs, which is called pulmonary embolism.

The new study, published in the Jan. 18 Journal of the American Medical Association, seeks to provide a reliable benchmark of this risk, but many experts in the field worry that the actual risk of blood clots after joint replacement is really much higher than this study suggests.

Researchers led by Jean-Marie Januel, of the Lausanne University Hospital, in Switzerland, analyzed 47 studies comprising nearly 45,000 joint replacement cases. All patients received preventive measures to lower their risk of developing a blood clot. Despite this treatment, one in every 100 patients undergoing knee replacement and 1 in every 200 patients undergoing hip replacement developed a blood clot before hospital discharge. Prevention typically involves getting patients moving soon after surgery, providing compression stockings or boots and administering some type of medication that prevents clots from forming.

Dr. John Heit, a cardiologist at the Mayo Clinic in Rochester, Minn., wrote an editorial accompanying the new report.

“The authors are trying to estimate the magnitude of the problem among patients who receive the most effective prophylaxis available today,” Heit said. But the risk is actually much higher than the study suggests, he said. “One has to understand the period of risk extends beyond the duration of hospitalization, which these days, is really quite short.”

He added, “Orthopedic surgeons are very aware of this problem and do an excellent job in choosing patients that are most likely to benefit from surgery, and they are very religious in terms of providing some form of prophylaxis after surgery.”

Dr. Joel Buchalter, an orthopedic surgeon at Somers Orthopaedic Surgery and Sports Medicine Group in Carmel, N.Y., agreed. He said that the risk of blood clots after joint replacement surgery may be even higher. The new study looked only at patients who developed blood clots in the hospital, but these blood clots can develop weeks after the surgery, he said.

Signs of a blood clot may include swelling, tenderness and pain when flexing the ankle, Buchalter said. “If a person has any of these symptoms, an ultrasound exam can rule a blood clot in or out, but many times blood clots have no symptoms. Some people have a great-looking leg and have a blood clot and don’t even know it,” he said.

Dr. Mathias Bostrom, an orthopedic surgeon at the Hospital for Special Surgery in New York City, said that the risk for blood clots after a joint replacement is real. “The new study once again reinforces that even in 2012, the risk of blood clots after total knee or hip replacement surgery is significant,” Bostrom said. There are many new drugs available today to help lower risk for blood clots after surgery, but these do have risks of their own, he said.

SOURCES: John Heit, M.D., cardiologist, Mayo Clinic, Rochester, Minn.; Mathias Bostrom, M.D., orthopedic surgeon, Hospital for Special Surgery, New York City; Joel Scott Buchalter, M.D., orthopedic surgeon, Somers Orthopaedic Surgery and Sports Medicine Group, Carmel, N.Y.; Jan. 18, 2012, Journal of the American Medical Association

HealthDay

 

 

Resurfacing of humeral head restores intact geometry better than hemiarthroplasty

Monday, January 16th, 2012

Background:Resurfacing of the humeral head has gained interest as an alternative to traditional hemiarthroplasty because it preserves bone stock and respects the native geometry of the glenohumeral articulation. The purpose of this study was to compare the biomechanics of the intact glenohumeral joint with those following humeral head resurfacing and following hemiarthroplasty.

Methods:Seven fresh-frozen cadaveric shoulders were tested with the rotator cuff, pectoralis major, and latissimus dorsi musculature loaded with 20 N and the deltoid muscle loaded with 40 N in a custom shoulder testing system. Each specimen was tested in 20°, 40°, 60°, and 80° of vertical abduction. The articular surfaces of the humeral head and the glenoid were digitized to calculate the positions of the geometric center and apex of the humeral head relative to the geometric center of the glenoid at each testing position. The contact area and contact pressures were also measured with use of a Tekscan pressure sensor.

Results:The geometric center of the humeral head shifted by a mean (and standard error) of 2.2 ± 0.3 mm following humeral resurfacing and 4.7 ± 0.3 mm following hemiarthroplasty (p < 0.0002). The apex of the humeral head was shifted superiorly at all abduction angles following hemiarthroplasty (p < 0.03). Both humeral resurfacing and hemiarthroplasty decreased the glenohumeral contact area and increased the peak pressure.

Conclusions:Resurfacing more closely restored the geometric center of the humeral head than hemiarthroplasty did, with less eccentric loading of the glenoid.

Clinical Relevance:Compared with hemiarthroplasty, humeral resurfacing may limit eccentric glenoid wear and permit better function because the glenohumeral joint biomechanics and the moment arms of the rotator cuff and the deltoid muscle are restored more closely to those of the intact condition.

 

 

 


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