1. Total knee replacement (TKR) followed by 12 weeks of nonsurgical treatment yielded greater pain relief and functional improvement in patients with severe knee osteoarthritis compared to nonsurgical treatment alone.
2. TKR was associated with a significantly higher number of adverse events in patients compared to participants in the nonsurgical treatment group.
Evidence Rating Level: 1 (Excellent)
Study Rundown: TKR is a widely employed treatment for end-stage osteoarthritis of the knee. In 2012, more than 670,000 TKRs were performed in the United States, with corresponding aggregate charges estimated at $36.1 billion. As the average age of the population continues to increase, the number of TKRs is expected also to increase.
This study investigated the effectiveness of TKR versus nonsurgical treatment of severe osteoarthritis. Participants were randomly assigned in a 1:1 ratio to undergo TKR followed by 12 weeks of nonsurgical treatment or to receive only the 12 weeks of nonsurgical treatment. The TKR group had a significantly greater improvement in mean KOOS and all four subscales than did the nonsurgical-treatment group. Overall and episodic serious adverse events were significantly higher in the TKR group than in the nonsurgical treatment group. In the TKR group, the two most common serious adverse events were deep venous thrombosis and stiffness requiring brisement forcé. The study is limited because it does not include a sham-surgery control group and therefore the results of this study may be an overestimation.
Relevant Reading: Randomized trial support for orthopedic surgical procedures
In-Depth [randomized controlled trial]: This was a parallel-group, randomized, controlled trial and included 100 patients with radiographically confirmed knee osteoarthritis. Participants were randomly assigned to either the TKR group or the nonsurgical group. Both groups received a 12-week nonsurgical treatment program which consisted of exercise, education, dietary advice, use of insoles, and pain medication. The primary outcome of the study was the between-group difference in change from baseline to 12 months in the mean knee injury and osteoarthritis outcome score subscales (KOOS) and its four subscales covering pain, symptoms, activities of daily living and quality of life (KOOS4).
49 of 50 patients in the nonsurgical treatment group and 46 of 50 patients in the TKR group completed the 12-month follow up assessment. In the nonsurgical treatment group, 13 of 50 patients had a TKR before the 12 month follow up. There was a mean improvement of 16.5 (95% [CI], 10.2 to 22.7) in the KOOS4 score of the TKR group. In the nonsurgical treatment group, the increase in KOOS4 from baseline to month 12 was 16.0 (95% [CI], 10.1 to 21.9) whereas the increase in KOOS4 in the TKR group was 32.5 (95% [CI], 26.6 to 38.3). There were 8 serious adverse events involving the index knee in the TKR group versus 1 in the nonsurgical treatment group (p=0.05) and 24 versus 6 adverse events overall (p=0.005).
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