A Treatment Option for Patients with Persistent Pain after Partial Menisectomy for Meniscal Tear
Results from 2 prospective, concurrent clinical trials demonstrate that compared with non-surgical care alone, surgery with a synthetic meniscus implant provides superior relief in patients who continue to experience pain following arthroscopic partial menisectomy for a meniscal tear.
The research was presented at the American Orthopedic Medicine Society-Arthroscopy Association of North America Combined 2021 Annual Meeting by Wayne Gersoff, MD, from Advanced Orthopedic & Sports Medicine Specialists, Parker, Colorado.
Arthroscopic partial meniscectomy is the most common surgical treatment for symptomatic, irreparable meniscal tears that do not improve with non-surgical care. For many patients, arthroscopic partial meniscectomy is associated with improvements in knee pain and function, but a subset of patients reports persistent or recurrent knee pain 1 to 2 years after surgery. Current treatment options for this knee pain are limited, especially for patients considered too young for knee replacement.
To broaden treatment options for these patients, 2 Food and Drug Administration-regulated clinical trials were conducted in the US and pooled for analysis to compare a synthetic medial meniscus implant with non-surgical care in treating persistent or recurrent knee pain following previous partial meniscectomy. The polymeric medial meniscus implant mimics the biomechanical function of the natural medial meniscus and is intended to provide relief from pain and improved function in subjects with persistent knee pain following arthroscopic partial menisectomy.
Researchers from 3 centers enrolled 242 patients (176 investigational, 66 control) who were treated in 2 prospective, concurrent clinical trials in the US: a randomized controlled superiority trial comparing the medial meniscus implant with non-surgical care (control) and a single-arm, implant-only trial.
Eligible subjects had persistent knee pain previously treated with partial meniscectomy at least 6 months before trial entry. Treated subjects returned for follow-up visits at 1 month, 6 months, 1 year, and 2 years after surgery. Patient-reported knee pain, function, and quality of life were assessed using the Knee Injury and Osteoarthritis Outcome Score (KOOS).
Patients enrolled in the implant arm of the trial reported a 63.4% higher KOOS score than the control group. In addition, more patients in the control group opted to stop treatment (17.3%) compared with the implant group (10.5%). This difference was not statistically significant.
“Two-year results from 2 prospective, concurrent US clinical trials demonstrate that the synthetic meniscus implant provides superior relief from post-arthroscopic partial meniscectomy knee pain when compared with treatment with non-surgical care alone,” Dr. Gersoff said.
“Overall, the implant group experienced superior improvements and outcomes at 2 years compared with subjects receiving non-surgical care alone.”