Objectives It is demonstrated that Synvisc® (S) (3 intra-articular injections at 1 week apart) improved algofunctional status of patients with knee OA. In this cohort study, the efficacy of S. was followed for up to 2 years in a specific population of patients with severe knee OA, confirmed clinically and radiologically. One half of those patients were candidates for a total knee replacement.
Methods In all patients treated with S. between June 1998 and September 1999, demographic data and medical history were recorded. Following S. course, a rheumatological evaluation was performed to assess improvement and local safety. Then, a long-term follow-up was performed in May 2000, all patients completing a questionnaire recording their clinical status, global satisfaction, tolerance of S. and concomitant therapies consumption. Due to methodology of this study, patients? long-term follow-up ranked from 9 to 24 (mean = 15.5) months.
Results Out of 117 patients treated, 81 (70%) completed the follow-up questionnaire.
Baseline characteristics of those 81 patients are as follow:
demographic data: mean age = 71 years; female = 57%; BMI = 27.5 kg/m²;
medical history: mean disease duration = 8 years; femoro-tibial knee OA: 97% (isolated: 33% or associated with femoro-patelar knee OA: 64%); chondrocalcinose: 19%
At baseline, 54% of patients had a ?severe? and 42% a ?very severe? knee OA according to physician. Nineteen patients (23%) were treated by S. in both knees and 15 (19%) received two courses of S. in the same knee (mean time between these two courses = 11 months).
A clinically significant improvement (moderate, important or very important) was observed by the physician after 77% of S. courses, while this treatment was followed by transient local adverse events (pain, swelling) after only 15% of S. courses (3 IA injections).
The analysis of patients? questionnaires showed that 49% reported a ?severe? pain and 22% a ?very severe? pain before treatment with S. The treatment was considered as globally satisfactory by 63% of patients, the main symptoms improved being pain on movement (56% of patients) and nocturnal pain (52%). Out of daily living? activities, ascending and descending stairs were improved in 51% and 46% of patients respectively. Most patients (53%) improved their maximum distance walked and 22% resumed their leisure activities. Moreover 90% of them reported a good tolerance of S. and 47% decreased their analgesics and NSAIDs consumption.
Conclusion This study demonstrates the interest of high molecular viscosupplementation with Synvisc® in the management of severe knee OA patients. Of special interest, 32 patients (82%) out of 39 candidates for total knee replacement at baseline, were able to delay this surgical treatment.
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