VISCOSEAL® AIDS RECOVERY AFTER ARTHROSCOPY – A SINGLE BLIND, RANDOMISED, MULTICENTRE STUDY
Authors: Villamor et al.
References: Osteoarthritis & Cartilage 2004; 12(Suppl B)
Aim: To assess the safety and efficacy of Viscoseal® (TRB Chemedica AG, Germany), a synovial fluid substitute containing 0.5% hyaluronan for use after arthroscopy, on symptoms in the 4 week post-surgery period compared to standard protocol.
Methods: Patients (18-60 years old), requiring partial meniscectomy and/or osteochondral debridement were recruited after giving written informed consent and were randomised after confirmation of inclusion/exclusion criteria during arthroscopy. Those in the control group (CG) underwent standard arthroscopy while the other group (VG) received 10ml of Viscoseal® into the joint through the contro-lateral portal after the final joint lavage. No other intra-articular treatment was allowed. Only Diclofenac 50mg tablets were available as escape medication. From Day 1 to 7, patients recorded pain and Diclofenac intake daily in a diary and returned on Days 7, 12 and 28 (end of study) for assessments. The Mann-Whitney U test was used for the primary endpoint while the non-parametric Mann-Whitney U test and Mantal-Haenszel test were used for secondary endpoints.
Results: Ninety-three patients (66 males; mean age 44.7 + 12.75 years) were recruited and completed the study (CG: n = 45; VG: n = 48). Pain, which was similar in both groups at Day 0, decreased more rapidly in VG being significant (P<0.01) at Day 7 compared to CG. This was maintained until Day 28 (P < 0.05). AUC for pain (VAS) was 39% lower in VG than in CG (CG: 496.22; VG: 301.22) (P < 0.01). At Day 0, all patients had mild to severe pain on squatting. On Day 28, 53.3% in VG and 32.2% in CG had no pain on squatting. Diclofenac use was lower in VG on Day 1 post-surgery (1.6 + 1.1 tablets vs 1.9 + 1.9 in CG) and Day 28 (0.2 + 0.5 vs 0.7 + 1.0 in CG) indicating Viscoseal® had an NSAID sparing effect. By Day 28, 53.3% patients in VG returned to work compared to 32.4% in CG. By Day 28, 20% of the patients in the VG, compared to 13.5% in the CG, were able to practice sport. On Day 7 there was s 57% reduction in the sum of point scores for secondary efficacy parameters (meniscal examination, effusion, pain on squatting, Lachman test, knee rotation, MCL, LCL, etc) in the VG compared to 49% reduction in the CG. On Day 28, reductions were similar in both groups (73%). No adverse events were reported.
Conclusion: Viscoseal® was safe and effective in decreasing pain and improving function when used post-arthroscopy and resulted in an earlier return to work and sports practice.