Purpose: To determine if patients randomized to a knee immobilizer following a primary hamstring tendon anterior cruciate ligament (ACL) reconstruction have lower visual analog scale (VAS) pain scores at day two postoperative than patients who do not wear a knee immobilizer.
Method: Patients aged 18–40 with symptomatic ACL deficiency as determined by MRI or physical exam who met the study inclusion criteria were eligible. Patients meeting intra-operative inclusion critiera were randomized (immobilizer or no immobilizer) during wound closure. The immobilizer used was a soft unhinged brace with velcro straps and three metal bars (Breg). Pre, intra and post operative protocols were standardized. Analgesic use and VAS scores were recorded at: one hour after surgery, 8am and 8pm for the first two days postoperative, and 5pm for days 3–14 postoperative. Patients were examined by the surgeon within 14–28 days postoperative. Based on a published survey and the literature, the primary outcome was patient self-assessed pain using a 0–100mm VAS (no pain-worst pain) at day 2 postoperative. Secondary outcomes included: analgesic use, complications, and range of motion. A sample size estimate was calculated resulting in 44 patients per group. A total of 102 patients were enrolled; 88 randomized and 14 excluded intra-operatively. Recruitment was achieved within 11 months.
Results: There was no difference in mean VAS pain scores at 2 days post-operative between immobilized and non-immobilized patients (32.6 and 35.2, respectively; p=0.59, 95% CI −6.99, 12.3). Regardless of group allocation, the greatest pain reported was on the evening of day 1 post-operative. Throughout the first week, patients medicated to a pain level of approximately 30/100. There were no differences between groups in medication consumed, range of motion or complications. At 2 days post-operative all patients randomized to the immobilizer group reported that they worn their brace 76–100% of the time.
Conclusion: No differences in pain were detected between immobilized and non-immobilized patients at any point during 14 days post ACL reconstruction. Based on these findings, a knee immobilizer is not recommended post-operatively for pain control. This study does not address other reasons for immobilizer use such as graft protection or range of motion.
