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Wijnand A C Palmbergen, Roy Beekman, A Marijne Heeren, Bart F L van Nuenen, Tim W H Alleman, Esther Verstraete, Korné Jellema, Wim I M Verhagen, Leo H Visser, Godard C W de Ruiter, Diederik van de Beek, Corianne A J M de Borgie, Johannes A Bogaards, Rob M A de Bie, Camiel Verhamme, Dutch CTS study group
Background: Surgery and corticosteroid injections are established treatments for carpal tunnel syndrome, but the optimal treatment strategy remains unclear. This study aimed to compare starting treatment with surgery versus starting with a corticosteroid injection.
Methods: We conducted an open-label, randomised controlled trial across 31 hospitals in the Netherlands. Eligible patients, diagnosed with carpal tunnel syndrome for at least 6 weeks and confirmed by electrophysiological or sonographic testing, were randomly assigned (1:1) to start treatment with either surgery or an injection via a web-based system. Randomisation was stratified by unilateral or bilateral symptoms, carpal tunnel syndrome with or without concomitant disease as risk factor, and previous ipsilateral injections. If needed, additional treatments were allowed, such as additional injections or surgery. The primary outcome, assessed in the intention-to-treat population, was the proportion of patients who were recovered (defined as a score of less than eight points on the six-item carpal tunnel syndrome scale) at 18 months. The trial was preregistered with the ISRCTN Registry (ISRCTN13164336) and is now completed.
Findings: From Nov 7, 2017, to Nov 4, 2021, 934 participants (545 female and 389 male participants) were included. 468 were randomised to the surgery group and 466 to the injection group. At 18 months, 805 (86%) of 934 participants had primary outcome data. In the surgery group, 243 (61%) of 401 participants had recovered, significantly higher than the 180 (45%) of 404 participants recovered in the injection group (relative risk 1·36; 95% CI 1·19-1·56; p<0·0001). One or more adverse event occurred in 376 (86%) of 436 participants in the surgery group and in 384 (85%) of 453 participants in the injection group. One participant in the surgery group was hospitalised due to complications. No treatment-related deaths were reported.
Interpretation: In patients with carpal tunnel syndrome, initiating treatment with surgery offers a higher chance of recovery after 18 months compared with starting with a corticosteroid injection, even with the possibility of additional interventions.
Funding: The Netherlands Organization for Health Research and Development and Zorgverzekeraars Nederland.
Noordyun, J. C. A., Van de Graaf, V. A., Willigenburg, N. W., Scholten-Peeters, G. G. M., Kret, E. J., Van Dijk, R. A., Buchbinder, R., Hawker, G. A., Coppieters, M. W., Poolman, R. W., ESCAPE Research Group
Importance: There is a paucity of high-quality evidence about the long-term effects (ie, 3-5 years and beyond) of arthroscopic partial meniscectomy vs exercise-based physical therapy for patients with degenerative meniscal tears.
Objectives: To compare the 5-year effectiveness of arthroscopic partial meniscectomy and exercise-based physical therapy on patient-reported knee function and progression of knee osteoarthritis in patients with a degenerative meniscal tear.
Design, setting, and participants: A noninferiority, multicenter randomized clinical trial was conducted in the orthopedic departments of 9 hospitals in the Netherlands. A total of 321 patients aged 45 to 70 years with a degenerative meniscal tear participated. Data collection took place between July 12, 2013, and December 4, 2020.
Interventions: Patients were randomly allocated to arthroscopic partial meniscectomy or 16 sessions of exercise-based physical therapy.
Main outcomes and measures: The primary outcome was patient-reported knee function (International Knee Documentation Committee Subjective Knee Form (range, 0 [worst] to 100 [best]) during 5 years of follow-up based on the intention-to-treat principle, with a noninferiority threshold of 11 points. The secondary outcome was progression in knee osteoarthritis shown on radiographic images in both treatment groups.
Results: Of 321 patients (mean [SD] age, 58 [6.6] years; 161 women [50.2%]), 278 patients (87.1%) completed the 5-year follow-up with a mean follow-up time of 61.8 months (range, 58.8-69.5 months). From baseline to 5-year follow-up, the mean (SD) improvement was 29.6 (18.7) points in the surgery group and 25.1 (17.8) points in the physical therapy group. The crude between-group difference was 3.5 points (95% CI, 0.7-6.3 points; P < .001 for noninferiority). The 95% CI did not exceed the noninferiority threshold of 11 points. Comparable rates of progression of radiographic-demonstrated knee osteoarthritis were noted between both treatments.
Conclusions and relevance: In this noninferiority randomized clinical trial after 5 years, exercise-based physical therapy remained noninferior to arthroscopic partial meniscectomy for patient-reported knee function. Physical therapy should therefore be the preferred treatment over surgery for degenerative meniscal tears. These results can assist in the development and updating of current guideline recommendations about treatment for patients with a degenerative meniscal tear.
