Abstract | BACKGROUND: METHODS: We conducted a multicenter, randomized, double-blind, sham-controlled trial in 146 patients 35 to 65 years of age who had knee symptoms consistent with a degenerative medial meniscus tear and no knee osteoarthritis. Patients were randomly assigned to arthroscopic partial meniscectomy or sham surgery. The primary outcomes were changes in the Lysholm and Western Ontario Meniscal Evaluation Tool (WOMET) scores (each ranging from 0 to 100, with lower scores indicating more severe symptoms) and in knee pain after exercise (rated on a scale from 0 to 10, with 0 denoting no pain) at 12 months after the procedure. RESULTS: In the intention-to-treat analysis, there were no significant between-group differences in the change from baseline to 12 months in any primary outcome. The mean changes (improvements) in the primary outcome measures were as follows: Lysholm score, 21.7 points in the partial- meniscectomy group as compared with 23.3 points in the sham-surgery group (between-group difference, -1.6 points; 95% confidence interval [CI], -7.2 to 4.0); WOMET score, 24.6 and 27.1 points, respectively (between-group difference, -2.5 points; 95% CI, -9.2 to 4.1); and score for knee pain after exercise, 3.1 and 3.3 points, respectively (between-group difference, -0.1; 95% CI, -0.9 to 0.7). There were no significant differences between groups in the number of patients who required subsequent knee surgery (two in the partial- meniscectomy group and five in the sham-surgery group) or serious adverse events (one and zero, respectively). CONCLUSIONS: In this trial involving patients without knee osteoarthritis but with symptoms of a degenerative medial meniscus tear, the outcomes after arthroscopic partial meniscectomy were no better than those after a sham surgical procedure. (Funded by the Sigrid Juselius Foundation and others; ClinicalTrials.gov number, NCT00549172.).
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Authors | Raine Sihvonen, Mika Paavola, Antti Malmivaara, Ari Itälä, Antti Joukainen, Heikki Nurmi, Juha Kalske, Teppo L N Järvinen, Finnish Degenerative Meniscal Lesion Study (FIDELITY) Group |
Journal | The New England journal of medicine
(N Engl J Med)
Vol. 369
Issue 26
Pg. 2515-24
(Dec 26 2013)
ISSN: 1533-4406 [Electronic] United States |
PMID | 24369076
(Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Chemical References |
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Topics |
- Adult
- Aged
- Arthroscopy
(methods)
- Double-Blind Method
- Exercise Therapy
- Female
- Humans
- Intention to Treat Analysis
- Knee Injuries
(rehabilitation, surgery)
- Male
- Menisci, Tibial
(surgery)
- Middle Aged
- Pain
- Pain Measurement
- Placebos
- Postoperative Care
- Tibial Meniscus Injuries
- Treatment Outcome
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