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      Lateral Extra-articular Tenodesis Reduces Failure of Hamstring Tendon Autograft Anterior Cruciate Ligament Reconstruction: 2-Year Outcomes From the STABILITY Study Randomized Clinical Trial

      1 , 1 , 1 , 1 , 1 , 1 , 1 , 1 , 1 , 1 , 1 , 1 , 1 , 1 , 1 , 1 , 1 , 1 , 1 , 1 , 1 , 1 , 1 , 1 , 1 , 1 , 1 , 1 , 1 , 1 , 1 , 1 , 1 , 1 , 1 , 1 , 1 , 1 , 1 , 1 , 1 , 1 , 1 , 1 , 1 , 1 , 1 , 1 , 1 , 1 , 1 , 1 , 1 , 1 , 1 , 1 , 1 , 1 , 1 , 1 , 1 , 1 , 1 , 1 , 1 , 1 , 1 , 1 , 1 , 1 , 1 , 1 , 1 , 1 , 1 , the STABILITY Study Group

      The American Journal of Sports Medicine

      SAGE Publications

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          Abstract

          Background:

          Persistent anterolateral rotatory laxity after anterior cruciate ligament (ACL) reconstruction (ACLR) has been correlated with poor clinical outcomes and graft failure.

          Hypothesis:

          We hypothesized that a single-bundle, hamstring ACLR in combination with a lateral extra-articular tenodesis (LET) would reduce the risk of ACLR failure in young, active individuals.

          Study Design:

          Randomized controlled trial; Level of evidence, 1.

          Methods:

          This is a multicenter, prospective, randomized clinical trial comparing a single-bundle, hamstring tendon ACLR with or without LET performed using a strip of iliotibial band. Patients 25 years or younger with an ACL-deficient knee were included and also had to meet at least 2 of the following 3 criteria: (1) grade 2 pivot shift or greater, (2) a desire to return to high-risk/pivoting sports, (3) and generalized ligamentous laxity (GLL). The primary outcome was ACLR clinical failure, a composite measure of rotatory laxity or a graft rupture. Secondary outcome measures included the P4 pain scale, Marx Activity Rating Scale, Knee injury Osteoarthritis and Outcome Score (KOOS), International Knee Documentation Committee score, and ACL Quality of Life Questionnaire. Patients were reviewed at 3, 6, 12, and 24 months postoperatively.

          Results:

          A total of 618 patients (297 males; 48%) with a mean age of 18.9 years (range, 14-25 years) were randomized. A total of 436 (87.9%) patients presented preoperatively with high-grade rotatory laxity (grade 2 pivot shift or greater), and 215 (42.1%) were diagnosed as having GLL. There were 18 patients lost to follow-up and 11 who withdrew (~5%). In the ACLR group, 120/298 (40%) patients sustained the primary outcome of clinical failure, compared with 72/291 (25%) in the ACLR+LET group (relative risk reduction [RRR], 0.38; 95% CI, 0.21-0.52; P < .0001). A total of 45 patients experienced graft rupture, 34/298 (11%) in the ACLR group compared with 11/291 (4%) in the ACL+LET group (RRR, 0.67; 95% CI, 0.36-0.83; P < .001). The number needed to treat with LET to prevent 1 patient from graft rupture was 14.3 over the first 2 postoperative years. At 3 months, patients in the ACLR group had less pain as measured by the P4 ( P = .003) and KOOS ( P = .007), with KOOS pain persisting in favor of the ACLR group to 6 months ( P = .02). No clinically important differences in patient-reported outcome measures were found between groups at other time points. The level of sports activity was similar between groups at 2 years after surgery, as measured by the Marx Activity Rating Scale ( P = .11).

          Conclusion:

          The addition of LET to a single-bundle hamstring tendon autograft ACLR in young patients at high risk of failure results in a statistically significant, clinically relevant reduction in graft rupture and persistent rotatory laxity at 2 years after surgery.

          Registration:

          NCT02018354 ( ClinicalTrials.gov identifier)

          Related collections

          Most cited references 59

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          Knee Injury and Osteoarthritis Outcome Score (KOOS)--development of a self-administered outcome measure.

          There is broad consensus that good outcome measures are needed to distinguish interventions that are effective from those that are not. This task requires standardized, patient-centered measures that can be administered at a low cost. We developed a questionnaire to assess short- and long-term patient-relevant outcomes following knee injury, based on the WOMAC Osteoarthritis Index, a literature review, an expert panel, and a pilot study. The Knee injury and Osteoarthritis Outcome Score (KOOS) is self-administered and assesses five outcomes: pain, symptoms, activities of daily living, sport and recreation function, and knee-related quality of life. In this clinical study, the KOOS proved reliable, responsive to surgery and physical therapy, and valid for patients undergoing anterior cruciate ligament reconstruction. The KOOS meets basic criteria of outcome measures and can be used to evaluate the course of knee injury and treatment outcome.
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            Articular mobility in an African population.

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              Return to sport following anterior cruciate ligament reconstruction surgery: a systematic review and meta-analysis of the state of play.

              An athlete's intention to return to sport following anterior cruciate ligament (ACL) injury is a major indication for surgical intervention. The purpose of this review was to determine postoperative return-to-sport outcomes after ACL reconstruction surgery. Meta-analysis and systematic review Electronic databases including Medline, Embase, SPORTDiscus and CINAHL were searched from the earliest possible entry to April 2010. Studies were included that reported the number of patients returning to sports participation following ACL reconstruction surgery. The results were presented using the World Health Organization's International Classification of Functioning, Disability and Health as a framework and combined using proportion meta-analyses. Forty-eight studies evaluating 5770 participants at a mean follow-up of 41.5 months were included for review. Overall, 82% of participants had returned to some kind of sports participation, 63% had returned to their preinjury level of participation, and 44% had returned to competitive sport at final follow-up. Approximately 90% of participants achieved normal or nearly normal knee function when assessed postoperatively using impairment-based outcomes such as laxity and strength, and 85% when using activity-based outcomes such as the International Knee Documentation Committee knee evaluation form. Fear of reinjury was the most common reason cited for a postoperative reduction in or cessation of sports participation. The relatively low rate of return to competitive sport despite the high rates of successful outcome in terms of knee impairment-based function suggests that other factors such as psychological factors may be contributing to return-to-sport outcomes.
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                Author and article information

                Journal
                The American Journal of Sports Medicine
                Am J Sports Med
                SAGE Publications
                0363-5465
                1552-3365
                February 2020
                January 15 2020
                February 2020
                : 48
                : 2
                : 285-297
                Affiliations
                [1 ]Investigation performed at The Fowler Kennedy Sport Medicine Clinic, Western University, London, Ontario, Canada
                Article
                10.1177/0363546519896333
                © 2020

                http://journals.sagepub.com/page/policies/text-and-data-mining-license

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