Objectives:
To review patient outcome measures at 1 year in patients who underwent the Bridge-Enhanced-ACL-Restoration (BEAR) procedure in the BEAR III clinical trial.
Methods:
Prospective analysis was performed for 151 consecutive patients who underwent the BEAR procedure as part of the BEAR III clinical trial. IKDC and KOOS scores were collected at baseline, 6, 9, and 12 months. Marx Activity Scales were collected at baseline, 9 and 12 months. Patients were analyzed based upon age greater than or less than 18.
Results:
All timepoints for IKDC [6 months (70+14; N=147), 9 months (79+15; N=139), and 12 months (83+16; N=130)] were statistically improved compared to baseline (45+14; N=150; p<0.0001). All timepoints for all five KOOS subscales [6 months (N=148), 9 months (N=145), and 12 months (N=138)] were statistically improved compared to baseline (P<0.0001). All postoperative timepoints for the MARX activity scale [9 months (9.6+5.5; N=141), 12 months (9.1+5.3; N=130)] were statistically inferior to baseline (12.8+4.5; N=150); p<0.0001].
All postoperative IKDC scores were statistically superior in patients <18 compared to >18 (p<0.001) but baseline scores were similar (48+13 <18 vs 44+15 >18; p=0.14). All preoperative KOOS domains were statistically similar between age groups except for the Function: Sports and Recreational Activities (41+27 <18 vs 31+27 >18; p=0.04). All postoperative KOOS domain scores were statistically superior in patients <18 compared to >18 (range p<0.03 to p<0.001) except for 1 year Quality of Life (70+21 <18 vs 67+22 >18; p=0.49). All Marx activity scores were statistically superior in patients <18 but age did not affect change from baseline at 9 or 12 months
Conclusions:
There were statistically significant improvements in IKDC and KOOS at all timepoints after BEAR. Marx Activity Scale scores were statistically inferior to baseline. Younger age consistently demonstrated statistically better postoperative scores. Further analysis at longer time intervals is warranted.
