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NCT07318272

Clinical and Functional Outcomes After ACL Reconstruction Versus Primary Repair

Sponsor: Gazi University

View on ClinicalTrials.gov

Summary

The anterior cruciate ligament (ACL) is the primary structure responsible for controlling anterior-posterior translation and rotational stability of the knee joint. Although ACL reconstruction has long been considered the gold standard among surgical interventions following ACL injury, arthroscopic primary repair techniques have recently regained interest. With advances in minimally invasive surgical procedures, refined patient selection criteria, and improved rehabilitation strategies, the clinical effectiveness of primary repair is once again being re-evaluated. However, there remains a limited body of literature directly comparing the medium- to long-term effects of these two surgical techniques on neuromuscular performance, fatigue tolerance, and functional outcomes. The aim of this study is to comparatively investigate postoperative muscle strength and endurance, isokinetic fatigue response, muscle oxygenation, proprioception, knee stability, postural control, and patient-reported outcome measures in individuals who have undergone ACL reconstruction or primary repair. Assessments will include low- and high-velocity tests performed on the Cybex Norm isokinetic dynamometer, a 33-repetition fatigue protocol at 300°/s, muscle oxygenation analysis using Train.Red NIRS, knee laxity measurement via the GNRB arthrometer, single-leg balance and landing evaluations using the KFORCE force platform, and subjective outcome measures (IKDC, ACL-RSI). The findings of this study are expected to provide a more comprehensive understanding of how surgical technique influences physiological, biomechanical, and functional outcomes. This knowledge may contribute to the development of individualized rehabilitation approaches and evidence-based return-to-sport criteria.

Official title: Comparison of Clinical and Functional Outcomes After Anterior Cruciate Ligament Reconstruction and Primary Repair Surgery

Key Details

Gender

All

Age Range

18 Years - 40 Years

Study Type

OBSERVATIONAL

Enrollment

Start Date

2026-01-01

Completion Date

2027-08-30

Last Updated

2026-01-05

Healthy Volunteers

Yes

Conditions

Anterior Cruciate Ligament (ACL) Tear Anterior Cruciate Ligament Reconstruction Isokinetic Test

Inclusion Criteria for the ACL Reconstruction Group * Age 18-40 years * History of complete ACL rupture treated with ACL reconstruction * Surgery performed at Gazi University Department of Orthopedics and Traumatology * At least 12 months postoperative at the time of evaluation * Ability to comply with all study procedures * Signed informed consent Exclusion Criteria for the ACL Reconstruction Group * Previous surgery for partial or chronic ACL tear * Concomitant multi-ligament knee injuries * Prior surgery on the ipsilateral or contralateral knee * Lower extremity malalignment (e.g., significant varus/valgus) * Tibial avulsion-type ACL injury * Neurological or musculoskeletal disorders affecting lower limb function * Any medical condition that may interfere with test performance or safety Inclusion Criteria for the Primary ACL Repair Group * Age 18-40 years * Complete ACL rupture treated with arthroscopic primary ACL repair * Surgery performed at Gazi University Department of Orthopedics and Traumatology * Minimum 12 months postoperative at the time of assessment A-bility to follow and complete study procedures * Signed informed consent Exclusion Criteria for the Primary ACL Repair Group * Previous surgery for partial or chronic ACL injury * Multi-ligament knee injuries * History of surgery on either knee * Lower extremity malalignment * Tibial avulsion-type ACL rupture * Neuromuscular or musculoskeletal diseases affecting lower limb function or balance * Any condition that may affect participation or compromise safety Inclusion Criteria for the Healthy Control Group * Age 18-40 years * No significant lower-extremity malalignment (e.g., varus/valgus deformity) * No history of lower-extremity injury within the past 12 months * No known chronic systemic disease * No history of knee surgery or diagnosed knee pathology * Ability to understand and comply with study procedures * Signed informed consent Exclusion Criteria for the Healthy Control Group * Presence of clinically significant lower-extremity malalignment * Lower-extremity musculoskeletal injury within the last 12 months * Any chronic systemic or metabolic disease * History of knee injury, knee surgery, or diagnosed knee pathology * Neurological, vestibular, or musculoskeletal disorder affecting balance or gait * Inability to complete study procedures

Locations (1)

Gazi University Faculty of Health Sciences Department of Physiotherapy and Rehabilitation

Ankara, Çankaya, Turkey (Türkiye)