Abstract

Dynamic intraligamentary stabilization was recently proposed as an option for the treatment of acute ACL ruptures. The aim of this study was to investigate the feasibility of the procedure in mid-substance ACL ruptures andexamine whether the additional application of a bilayer collagen I/III membrane would provide for a superior outcome. The study group consisted of patients presenting with a mid-substance ACL rupture undergoing dynamic intraligamentary stabilization using the Ligamys™ device along with application of a collagen I/III membrane to the surface of the ACL (group A, n=23). The control group comprised a matched series of patients presenting with a mid-substance ACL rupture also treated by dynamic intraligamentary stabilization Ligamys™ repair, however, without additional collagen application (group B, n=33). Patients were evaluated preoperatively and at 24-month follow-up forstability as well as Tegner and Lysholm scores. Knee laxity was measured as a difference in anterior translation (ΔAP) and pivot shift. Any events occurring during the follow-up period of 24months were documented. Logistic regression of complications was performed, and adjustment undertaken where necessary. A hightotal complication rate of 78.8% was noted in group B, compared to group A (8.7%) (p=0.002). The addition of a collagen membrane was the only independent prognostic factor associated with reduced complications (OR 8.0, CI 2.0-32.2, p=0.003, for collagen-free treatment). In group B, 6 patients suffered a re-rupture with subsequent instability requiring secondary hamstring reconstruction surgery, and 11 developed extension loss requiring arthroscopic debridement, whilstin group A, 2 patients required arthroscopic debridement for loss of exension, with no further encountered complication.Median Lysholm score was significantly higher in group A compared to group B (median 100 range 93-100vs median 95 range 60-100, p=0.03) at final follow-up. A high complication rate following ACL Ligamys™ repair of mid-substance ruptures was noted. Application of a collagen membrane to the surface of the ACL resulted in a reduced incidence of extension deficit and re-ruptures. The results indicate that solitary ACL Ligamys™ repair does not present an appropriate treatment modality for mid-substance ACL ruptures. Collage application proved to providehealingbenefitswith superiorclinicaloutcome after ACL repair. Case control study, Level III.

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