Knee Immobilization for Pain Control after a Hamstring Tendon Anterior Cruciate Ligament Reconstruction: A Randomized Clinical Trial

Background This study will attempt to evaluate the efficacy of knee immobilization on patient pain levels after an anterior cruciate ligament reconstruction. Hypothesis There is no difference in visual analog scale pain scores 2 days after anterior cruciate ligament reconstruction between patients who wear a knee immobilizer and those who do not wear a knee immobilizer. Study Design Randomized clinical trial; Level of evidence, 1. Methods Patients aged 18 to 40 years who met study inclusion criteria were eligible. Patients meeting intraoperative inclusion critiera were randomized (immobilizer or no immobilizer) after wound closure. The immobilizer used was a soft, unhinged brace with Velcro® straps. Preoperative, intraoperative, and postoperative protocols were standardized. The primary outcome was patient self-assessed pain using a 0-to-100-mm visual analog scale at day 2 after surgery. Secondary outcomes included pain and analgesic use in the first 14 days after surgery, complications, and range of motion (approximately 3 weeks postoperatively). A sample size estimate was calculated and resulted in the need for 44 patients per group. Results A total of 102 patients were enrolled; 88 patients were randomized, and 14 were excluded intraoperatively. There was no difference in mean visual analog scale pain scores at 2 days after surgery between immobilized and nonimmobilized patients (32.6 and 35.2, respectively; P = .59; difference, —2.6; 95% confidence interval, —12.2 to 6.9). There were no differences between groups in medication consumed, range of motion, or complications. Pain and analgesic use were the same for both groups at 7 and 14 days postoperatively. Conclusion No differences in pain or any of the secondary outcomes were detected between immobilized and nonimmobilized patients at any point during the first 14 days after anterior cruciate ligament reconstruction.