Intra-articular hylastan versus steroid for knee osteoarthritis.

PURPOSE: To assess the efficacy and safety of one and two intra-articular (IA) injections of the new viscosupplement, hylastan, compared with a single IA corticosteroid injection for pain due to knee osteoarthritis (OA). Hylastan is a high-molecular-weight hyaluronan derivative prepared from bacterial fermented sodium hyaluronate that was developed to remain in the joint for longer than most other viscosupplements. METHODS: This 6-month, double-blind, randomized, parallel group, multicenter trial enrolled patients aged ≥40 years who met American College of Rheumatology criteria for knee OA and had continued pain despite conservative treatment. Patients were randomized 1:1:1 to one of three arms: 2 × 4 mL hylastan (n = 129; arthrocentesis then IA hylastan Day 0, same treatment Week 2); 1 × 4 mL hylastan (n = 130; arthrocentesis then IA hylastan Day 0, arthrocentesis only Week 2); steroid (n = 132; arthrocentesis then IA methylprednisolone acetate 40 mg Day 0, arthrocentesis only Week 2). Participants and evaluators were blinded to treatment. The primary clinical outcome measure was change from baseline in WOMAC A pain score over all postbaseline visits to Week 26. RESULTS: Statistically significant pain reduction was observed in all three arms, with similar mean (95 % CI) changes in WOMAC A: 2 × 4 mL hylastan -0.9 (-1.0, -0.7); 1 × 4 mL hylastan -0.8 (-0.9, -0.7); steroid -0.9 (-1.0, -0.8); all P < 0.0001 versus baseline. Changes in secondary outcomes (OMERACT-OARSI and WOMAC A responder rates, patient/clinical observer global assessments, and WOMAC A1 walking pain) were similar in all three arms. Target knee adverse events were comparable for all treatments. CONCLUSIONS: Both IA hylastan injection regimens were effective in relieving pain with an acceptable safety profile. IA hylastan did not show a difference versus IA corticosteroid; therefore, the hypothesis of superior pain relief was not met. Further research is needed to compare the efficacy and safety of hylastan with other viscosupplements.

Five year results of the first US FDA-approved hip resurfacing device.

A prospective, multi-center postmarket approval study has been ongoing since May 2006 to assess safety and efficacy of the first US FDA approved hip resurfacing implant. 265 patients have been enrolled at five study sites. The average age of the patients is 51.3 years. There have been 7 revisions (2.4%) in the cohort to date. K-M survival curves for the cohort are 97.6% at 5 years. There is a trend toward a gender difference in implant survivorship, with 98.6% of men and 94.7% of women free from revision. Metal ion analysis revealed median cobalt and chromium levels of 1.5 ppb and 1.7 ppb at 1 year. In this prospective US study, the Birmingham Hip Resurfacing implant is demonstrating results comparable to those in the literature.

Results of the First U.S. FDA-Approved Hip Resurfacing Device at 10-Year Follow-up.

BACKGROUND: The BIRMINGHAM HIP Resurfacing (BHR) system is a metal-on-metal hip implant system approved by the U.S. Food and Drug Administration in 2006. The approval required a multicenter, prospective, post-market-approval study. Our purpose is to report the current results at 10 years of follow-up. METHODS: Between October 2006 and December 2009, 280 primary BHR procedures were performed at 5 sites. Outcome measures included Kaplan-Meier survivorship, reasons for revision, radiographic component stability and osteolysis, Harris hip scores, and metal levels including cobalt and chromium. The mean age at the time of the procedure was 51.3 ± 7.1 years, 74% (206) of 280 BHRs were implanted in male patients, the mean body mass index was 27.8 ± 4.4 kg/m2, and 95% (265) of 280 hips had a primary diagnosis of osteoarthritis. The mean follow-up among all 280 hips was 9.0 ± 2.5 years. Prior to 10-year follow-up, 20 hips were revised and 5 patients representing 5 hips had died. Among the remaining 255 hips, 218 (85%) met the minimum follow-up of 10 years. RESULTS: The 10-year survival free from all-cause component revision was 92.9% (95% confidence interval [CI], 89.8% to 96.1%) for all hips and 96.0% (95% CI, 93.1% to 98.9%) among male patients <65 years old at the time of the procedure. Reasons for revision included femoral loosening (n = 5), femoral neck fracture (n = 3), pseudotumor (n = 3), osteolysis (n = 2), and acetabular loosening (n = 1), as well as 6 revisions for a combination of pain, noise, or metal levels. Among unrevised hips, the median Harris hip score improved from preoperatively (59) to 1 year postoperatively (99; p < 0.001) and remained stable through 10 years postoperatively (99; p = 0.08). Radiographically, 5% (10) of 218 unrevised hips had osteolysis with no component migration. Median metal levels had increased at 1 year postoperatively (cobalt: from 0.12 ppb preoperatively to 1.5 ppb at 1 year postoperatively, p < 0.001; chromium: from 0.6 ppb preoperatively to 1.7 ppb at 1 year postoperatively, p < 0.001), then remained stable through 5 years before slightly decreasing at 10 years postoperatively (cobalt: 1.3 ppb, p < 0.001; chromium: 1.4 ppb, p < 0.001). CONCLUSIONS: This prospective, multicenter, post-market-approval study demonstrated that the BHR implant system is safe and effective through 10 years of follow-up, particularly among young male patients. LEVEL OF EVIDENCE: Therapeutic Level IV. See Instructions for Authors for a complete description of levels of evidence.