Actual arthroscopic knee surgeries were not statistically better than sham surgeries - several studies
Arthroscopic Partial Meniscectomy for Degenerative Tear - 10-Year Outcomes - NEJM 2026
The New England Journal of Medicine 10.1056/NEJMc2516079
Kalske, Roope; Sihvonen, Raine; Paavola, Mika; Malmivaara, Antti; Itälä, Ari; Joukainen, Antti; Kalske, Juha; Nurmi, Heikki; Toivonen, Pirjo; Sillanpää, Niko; Kiekara, Tommi; Turkiewicz, Aleksandra; Englund, Martin; Taimela, Simo; Järvinen, Teppo L N; FIDELITY Investigators - Finland
Arthroscopic partial meniscectomy (APM) — keyhole resection of torn meniscus tissue — is commonly performed in middle-aged and older adults with knee pain attributed to a degenerative meniscal tear; it is among the most commonly performed orthopedic procedures worldwide.
Over the past decade, randomized trials comparing APM with nonoperative care or sham surgery have shown little or no benefit, while observational evidence has raised concern that APM may accelerate structural degeneration and increase the likelihood of subsequent knee replacement (1).
The FIDELITY trial (NCT00549172 and NCT01052233) is a multicenter, randomized, participant- and assessor-blinded, sham- surgery-controlled study evaluating APM for degenerative medial meniscal tear in adults without established radiographic osteoarthritis. Trial methods and short- and intermediate-term outcomes (2-5) have been published previously, and the study protocol is available with the full text of this letter at NEJM.org. Here we report the 10-year outcomes.
Participants underwent diagnostic arthroscopy to confirm eligibility before intraoperative randomization to APM or sham surgery. Over the 10-year follow-up, we collected repeated patient-reported outcome measures, serial radiographic assessments of osteoarthritis, and predefined clinical endpoints including reoperations and subsequent knee procedures (See supplementary appendix).
Of the 146 participants originally randomized, 64 of 70 (91%) in the APM group and 69 of 76 (91%) in the sham group completed 10-year follow-up (Tables S1 and S2). At 10 years, adjusted mean differences between the APM and sham surgery groups for the 3 primary patient- reported measures were: -9.4 points (98.33% CI, -17.0 to -1.7) for the WOMET score (assessing meniscal symptoms and related disability), - 5.1 points (98.33% CI, -11.2 to 0.95) for the Lysholm score (assessing knee function), and 0.86 points (98.33 CI, -0.12 to 1.85) for knee pain after exercise (Table 1 ; legend provides score ranges and interpretation.) Radiographic OA progression occurred in 81% of participants in the APM group and 70% in the sham group (adjusted risk difference, 12 percentage points; 95% CI, -1 to 26). Eight (11%) participants in the APM group and three (4%) in the sham group underwent knee replacement or high tibial osteotomy (Table 1). Findings were similar in sensitivity analyses censoring patient-reported data after knee replacement or osteotomy and accounting for missing radiographic outcome data (Tables S3 and S4).
Because the original study was designed to maximize the chance of detecting benefit from APM, we enrolled patients with minimal or no radiographic osteoarthritis. Yet, even in this low-risk group, we found no evidence of benefit and a suggestion of worse outcomes following APM.
Taken together with other evidence, these findings raise concern regarding the use of APM for degenerative meniscal tear in middle-aged and older adults.
- Sihvonen R, Paavola M, Malmivaara A, Itala A, Joukainen A, Nurmi H, et al. Arthroscopic partial meniscectomy versus sham surgery for a degenerative meniscal tear. N Engl J Med. 2013;369(26):2515-24.
- Sihvonen R, Englund M, Turkiewicz A, Jarvinen TL. Mechanical Symptoms and Arthroscopic Partial Meniscectomy in Patients With Degenerative Meniscus Tear: A Secondary Analysis of a Randomized Trial. Ann Intern Med. 2016;164(7):449-55.
- Sihvonen R, Paavola M, Malmivaara A, Itala A, Joukainen A, Nurmi H, et al. Arthroscopic partial meniscectomy versus placebo surgery for a degenerative meniscus tear: a 2-year follow-up of the randomised controlled trial. Ann Rheum Dis. 2018;77(2):188-95.
- Sihvonen R, Paavola M, Malmivaara A, Itala A, Joukainen A, Kalske J, et al. Arthroscopic partial meniscectomy for a degenerative meniscus tear: a 5 year follow-up of the placebo-surgery controlled FIDELITY (Finnish Degenerative Meniscus Lesion Study) trial. Br J Sports Med. 2020;54(22):1332-9.
709 - MULTICENTER RANDOMIZED CONTROLLED TRIAL OF STANDARD PHYSICAL THERAPY VS. SHAM PT IN PERSONS WITH KNEE PAIN, MENISCAL TEAR, AND OSTEOARTHRITIS -2025
"Conclusions: The outcomes of Standard PT and Sham PT were essentially identical at all time points. "
Sham Surgery Studies in Orthopaedic Surgery May Just Be a Sham: A Systematic Review of Randomized Placebo-Controlled Trials - 2020
Arthroscopy: The Journal of Arthroscopic & Related Surgery, Oct 2020, https://doi.org/10.1016/j.arthro.2020.05.001 PDF behind paywall
Seven sham surgery-controlled trials (845 subjects [370 knees, 449 shoulders, 26 elbows]; 5 from Europe, 1 from North America, and 1 from Australia;
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