Repair versus reconstruction for proximal anterior cruciate ligament tears: a study protocol for a prospective multicenter randomized controlled trial

For active patients with a tear of the anterior cruciate ligament (ACL) who would like to return to active level of sports, the current surgical gold standard is reconstruction of the ACL. Recently, there has been renewed interest in repairing the ACL in selected patients with a proximally torn liga...

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Bibliographic Details
Published in:	BMC musculoskeletal disorders Vol. 22; no. 1; p. 399
Main Authors:	van der List, Jelle P, Vermeijden, Harmen D, Sierevelt, Inger N, Rademakers, Maarten V, Falke, Mark L M, Helmerhorst, Gijs T T, Hoogeslag, Roy A G, van der Wal, Wybren A, van Noort, Arthur, Kerkhoffs, Gino M M J
Format:	Journal Article
Language:	English
Published:	England BioMed Central Ltd 30-04-2021 BioMed Central BMC
Subjects:	Anterior cruciate ligament Anterior Cruciate Ligament Injuries - diagnostic imaging Anterior Cruciate Ligament Injuries - surgery Anterior Cruciate Ligament Reconstruction Anterior cruciate ligament repair Autografts Cartilage Clinical trials Follow-Up Studies Humans Injuries Knee Knee injury Knee Joint - surgery Ligaments Morbidity Motion detection Multicenter Studies as Topic Musculoskeletal diseases Netherlands Osteoarthritis Patients Primary repair Prospective Studies Proximal tear Randomized Controlled Trials as Topic Sports injuries Study Protocol Surgeons Surgery Systematic review Treatment Outcome Netherlands Anterior cruciate ligament reconstruction Ligament preservation Anterior cruciate ligament repair Suture repair Primary repair Remnant Knee injury Anterior cruciate ligament Proximal tear
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Summary:	For active patients with a tear of the anterior cruciate ligament (ACL) who would like to return to active level of sports, the current surgical gold standard is reconstruction of the ACL. Recently, there has been renewed interest in repairing the ACL in selected patients with a proximally torn ligament. Repair of the ligament has (potential) advantages over reconstruction of the ligament such as decreased surgical morbidity, faster return of range of motion, and potentially decreased awareness of the knee. Studies comparing both treatments in a prospective randomized method are currently lacking. This study is a multicenter prospective block randomized controlled trial. A total of 74 patients with acute proximal isolated ACL tears will be assigned in a 1:1 allocation ratio to either (I) ACL repair using cortical button fixation and additional suture augmentation or (II) ACL reconstruction using an all-inside autologous hamstring graft technique. The primary objective is to assess if ACL repair is non-inferior to ACL reconstruction regarding the subjective International Knee Documentation Committee (IKDC) score at two-years postoperatively. The secondary objectives are to assess if ACL repair is non-inferior with regards to (I) other patient-reported outcomes measures (i.e. Knee Injury and Osteoarthritis Outcome Score, Lysholm score, Forgotten Joint Score, patient satisfaction and pain), (II) objective outcome measures (i.e. failure of repair or graft defined as rerupture or symptomatic instability, reoperation, contralateral injury, and stability using the objective IKDC score and Rollimeter/KT-2000), (III) return to sports assessed by Tegner activity score and the ACL-Return to Sports Index at two-year follow-up, and (IV) long-term osteoarthritis at 10-year follow-up. Over the last decade there has been a resurgence of interest in repair of proximally torn ACLs. Several cohort studies have shown encouraging short-term and mid-term results using these techniques, but prospective randomized studies are lacking. Therefore, this randomized controlled trial has been designed to assess whether ACL repair is at least equivalent to the current gold standard of ACL reconstruction in both subjective and objective outcome scores. Registered at Netherlands Trial Register ( NL9072 ) on 25th of November 2020.
Bibliography:	ObjectType-Article-2 SourceType-Scholarly Journals-1 ObjectType-Undefined-1 ObjectType-Feature-3 content type line 23
ISSN:	1471-2474 1471-2474
DOI:	10.1186/s12891-021-04280-y