No increase in adverse events with lateral extra-articular tenodesis augmentation of anterior cruciate ligament reconstruction - Results from the stability randomized trial.

Autor:	Heard M; Deparment of Surgery, University of Calgary, T2N 1N4, Canada; Banff Sport Medicine, T1W 0L5, Canada., Marmura H; Fowler Kennedy Sport Medicine Clinic, N6A 3K7, Canada; School of Physical Therapy, Western University, N6A 3K7, Canada., Bryant D; Fowler Kennedy Sport Medicine Clinic, N6A 3K7, Canada; School of Physical Therapy, Western University, N6A 3K7, Canada., Litchfield R; Fowler Kennedy Sport Medicine Clinic, N6A 3K7, Canada; Department of Surgery, Schulich School of Medicine and Dentistry, Western University, N6A 5C1, Canada., McCormack R; Department of Orthopaedics, University of British Columbia, V5Z 1M9, Canada; New West Orthopaedic & Sports Medicine Centre, V3L 5P5, Canada., MacDonald P; Department of Surgery, University of Manitoba, R3A 1R9, Canada; Pan Am Clinic, R3M 3E4, Canada., Spalding T; University Hospital Coventry and Warwickshire NHS Trust, CV2 2DX, UK., Verdonk P; Department of Physical Medicine and Orthopedics, Ghent University, 9000, Belgium; Antwerp Orthopedic Center, 2018, Belgium., Peterson D; Department of Surgery, McMaster University, L8S 4K1, Canada., Bardana D; Department of Surgery, Queen's University, K7L 2V7, Canada., Rezansoff A; Deparment of Surgery, University of Calgary, T2N 1N4, Canada; University of Calgary Sport Medicine Centre, T2N 1N4, Canada., Getgood A; Fowler Kennedy Sport Medicine Clinic, N6A 3K7, Canada; Department of Surgery, Schulich School of Medicine and Dentistry, Western University, N6A 5C1, Canada. Electronic address: alan.getgood@uwo.ca.
Jazyk:	angličtina
Zdroj:	Journal of ISAKOS : joint disorders & orthopaedic sports medicine [J ISAKOS] 2023 Aug; Vol. 8 (4), pp. 246-254. Date of Electronic Publication: 2023 Jan 14.
DOI:	10.1016/j.jisako.2022.12.001
Abstrakt:	Objectives: Results from the Stability Study suggest that adding a lateral extra-articular tenodesis (LET) to a hamstring tendon autograft reduces the rate of anterior cruciate ligament reconstruction (ACLR) failure in high-risk patients. The purpose of this study is to report adverse events over the 2-year follow-up period and compare groups (ACLR alone vs. ACLR + LET). Methods: Stability is a randomized clinical trial comparing hamstring tendon ACLR with and without LET. Patients aged 14-25 years with an ACL deficient knee were included. Patients were followed and adverse events documented (type, actions taken, resolution) with visits at 3, 6, 12, and 24 months postoperatively. Adverse events were categorized as none, minor medical, minor surgical, contralateral ACL rupture, or graft rupture. Patient reported outcome measures (PROMs) collected at each visit included the Knee Injury and Osteoarthritis Outcome Score (KOOS), International Knee Documentation Committee Score (IKDC), and ACL Quality of Life Questionnaire (ACL-QOL). Results: In total, 618 patients were randomized (mean age 18.9 years, 302 (49%) male). Forty-five patients (7%) suffered graft rupture; 34 (11%) in the ACLR group compared to 11 (4%) in the ACLR + LET group (RRR = 0.67, 95% CI 0.36 to 0.83, p < 0.001). There were no differences in effusion or infection rates between groups. The ACLR + LET group experienced an increased number of hardware removals (10 vs. 4). Overall, the rate of minor medical events (11%), minor surgical events (7%), and ipsilateral or contralateral ACL tears (10%) were low considering the high-risk patient profile. Increasing severity of adverse events was associated with lower PROMs at 24 months post-operative. Patients in the ACLR + LET group reported greater degree of pain at 3 months only. There were no clinically significant differences in range of motion between groups. Conclusions: The addition of LET to hamstring tendon autograft ACLR in young patients at high risk of re-injury resulted in a statistically significant reduction in graft rupture. While the addition of LET may increase rates of hardware irritation, there was no significant increase in overall rates of minor medical adverse events, minor surgical events, or overall re-operation rates. The concerns regarding complications associated with a LET did not materialize in this study. Level of Evidence: Level I. Competing Interests: Declaration of competing interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: Alan Getgood reports financial support was provided by International Society for Arthroscopic Knee Surgery and Orthopaedic Sports Medicine (ISAKOS). Alan Getgood reports a relationship with Canadian Institutes of Health Research that includes: funding grants. Alan Getgood reports a relationship with National Institutes of Health that includes: funding grants. Alan Getgood reports a relationship with Academic Medical Organization of Southwestern Ontario that includes: funding grants. Alan Getgood reports a relationship with Canadian Foundation for Innovation that includes: funding grants. Alan Getood reports a relationship with Ontario Research Foundation that includes: funding grants. Alan Getgood reports a relationship with Smith and Nephew that includes: consulting or advisory, royalties and funding grants. Alan Getgood reports a relationship with Graymont Inc that includes: royalties. Alan Getgood reports a relationship with Ossur that includes: consulting or advisory. Alan Getgood reports a relationship with Olympus that includes: consulting or advisory. Robert Litchfield reports a relationship with Smith and Nephew that includes: consulting or advisory. Robert McCormack reports a relationship with Canadian Institutes of Health Research that includes: funding grants. Robert McCormack reports a relationship with National Institutes of Health that includes: funding grants. Robert McCormack reports a relationship with Orthopaedic Trauma Association that includes: funding grants. Robert McCormack reports a relationship with Physicians' Services Inc Foundation that includes: funding grants. Robert McCormack reports a relationship with Bioventus that includes: speaking and lecture fees. Robert McCormack reports a relationship with Pendopharm that includes: speaking and lecture fees. Robert McCormack reports a relationship with Smith and Nephew that includes: speaking and lecture fees. Robert McCormack reports a relationship with Sanofi that includes: speaking and lecture fees. Tim Spalding reports a relationship with Conmed that includes: consulting or advisory and speaking and lecture fees. Tim Spalding reports a relationship with Smith and Nephew that includes: speaking and lecture fees. Tim Spalding reports a relationship with Joint Operations that includes: speaking and lecture fees. Peter Verdonk reports a relationship with Conmed that includes: consulting or advisory and speaking and lecture fees. Peter Verdonk reports a relationship with Smith and Nephew that includes: speaking and lecture fees. Laurie Hiemstra reports a relationship with Conmed that includes: consulting or advisory and speaking and lecture fees. Hana Marmura reports a relationship with Canadian Institutes of Health Research that includes: funding grants. Hana Marmura reports a relationship with Western University Bone and Joint Institute that includes: funding grants. (Copyright © 2023 The Authors. Published by Elsevier Inc. All rights reserved.)
Databáze:	MEDLINE
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