Gap balanced adjusted mechanical alignment versus measured resection mechanical alignment: a randomised controlled trial.
OrthoEvidence Journal (OE Journal) - ACE Report
OE Journal. 2023;11(12):2 Arch Orthop Trauma Surg. 2023 Apr;143(4): 2141-2151.What this means for my practice?
The results of this randomized trial found that the use of the Equibalance instrumented gap balancer for mechanical alignment did not significantly improve knee extension power, but resulted in significantly less pain, better early improvements in balance, and better improvements in range of motion at 3 months compared to standard mechanical resection. This study had a limited sample size which may have resulted in Type II error. Moreover, the assessment of long-term outcomes and implant survivorship was not possible due to the short follow-up time. Long-term studies are required to assess the long-term efficacy and safety outcomes.
Study Summary
94 patients undergoing a total knee arthroplasty procedure were randomized to receive mechanical alignment with an individualized gap balancing technique (n=47) or with standard measured resection (n=47). The primary outcome of interest was knee extension power measured via the peak torque of the quadriceps. Secondary outcomes of interest included peak hamstring torque, balance, functional outcome measures (timed up and go test; 6-minute walk test; timed stairs test; range of motion), Knee Injury and Osteoarthritis Outcomes Scale (KOOS) pain scores, Oxford Knee Scores (OKS), and EQ-5D quality of life scores. Outcomes were assessed at 6 weeks, 3, 6, and 12 months post-operation. The gap balancing technique did not significantly improve knee extension power compared to measured resection at any time point. However, patients in the gap balancing technique group reported significantly better improvement in KOOS pain scores up to 6 months post-operation, better range of motion improvement at 3 months post-operation, and better improvement in balance at 6 weeks post-operation compared to the measured resection group.
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