Randomized Controlled Trial of Sensor-Guided Knee Balancing Compared to Standard Balancing Technique in Total Knee Arthroplasty
Abstract
BACKGROUND
Despite advances in total knee arthroplasty (TKA) technology, up to 1 in 5 patients remain dissatisfied. This study sought to evaluate if sensor-guided knee balancing improves postoperative clinical outcomes and patient satisfaction compared to a conventional gap balancing technique.
METHODS
We undertook a prospective double-blind randomized controlled trial of patients presenting for elective primary TKA to determine a difference in TKA soft tissue balance between a standard gap balancing (tensiometer) approach compared to augmenting the balance using a sensor-guided device. The sensor-guided experimental group had adjustments made to achieve a balanced knee to within 15 pounds of intercompartmental pressure difference. Secondary outcomes included differences in clinical outcome scores at 6 months and 1 year postoperative, including the Oxford Knee Score and Knee Society Score and patient satisfaction.
RESULTS
The sample comprised of 152 patients, 76 controls and 76 experimental sensor-guided cases. Within the control group, 36% (27/76) of knees were unbalanced based on an average coronal plane intercompartmental difference >15 pounds, compared to only 5.3% (4/76) within the experimental group (P < .0001). There were no significant differences in 1-year postoperative flexion, Knee Society Score, or Oxford scores. Overall, TKA patient satisfaction at 1 year was comparable, with 81% of controls and experimental cases reporting they were very satisfied (P = .992).…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 152 participants or records.
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