Comparable Instrumented Knee Joint Laxity and Patient-Reported Outcomes After ACL Repair With Dynamic Intraligamentary Stabilization or ACL Reconstruction: 5-Year Results of a Randomized Controlled Trial.

"One or more of the authors has declared the following potential conflict of interest or source of funding: M.H. is a consultant for Medacta, Conmed Linvatec, Olympus, and DJO. M.H., C.K., and B.S. are consultants for Mathys Medical. AOSSM checks author disclosures against the Open Payments Database (OPD). AOSSM has not conducted an independent investigation on the OPD and disclaims any liability or responsibility relating thereto."

"One or more of the authors has declared the following potential conflict of interest or source of funding: M.H. is a consultant for Medacta, Conmed Linvatec, Olympus, and DJO. M.H., C.K., and B.S. are consultants for Mathys Medical. AOSSM checks author disclosures against the Open Payments Database (OPD). AOSSM has not conducted an independent investigation on the OPD and disclaims any liability or responsibility relating thereto."

"A single-center RCT was performed. Institutional review board approval was obtained before the study (2013-414-f-S) and registered on the World Health Organization’s International Clinical Trials Registry Platform (DRKS0 0015466). In 2014 and 2015, patients aged between 18 and 50 years with the clinical diagnosis of an acute injury of the ACL (recent trauma with positive Lachman or pivot-shift test findings) were included if a proximal or midsubstance tear was confirmed by magnetic resonance imaging and if surgical treatment was possible within 3 weeks after the injury. Patients with previous knee injuries of the affected or contralateral knee or concomitant lesions such as meniscal tears, cartilage injuries, and collateral ligament injuries that would alter the operative procedure or the postoperative rehabilitation program were excluded. Stable meniscal lesions that neither required surgical treatment nor affected the rehabilitation protocol did not lead to exclusion. A block randomization protocol (n = 4 per block) was used to assign patients to undergo either ACL repair with DIS (Ligamys; Mathys Medical) or ACL reconstruction with an ipsilateral semitendinosus tendon autograft. A resident, who was not involved in the study, opened a sealed envelope just before surgery to allocate the patients to one of the treatment groups. Registration:: DRKS00015466 (German Clinical Trials Register)."