Name: Comparison of Clinical and Functional Outcomes After Anterior Cruciate Ligament Reconstruction and Primary Repair Surgery
Creator: Gazi University
Published: 2026-01-05
License: https://www.clinicaltrials.gov/about-site/terms-conditions#availability

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	Clinical Trial NCT07318272 for Anterior Cruciate Ligament (ACL) Tear, Anterior Cruciate Ligament Reconstruction, Isokinetic Test is not yet recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.

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Clinical and Functional Outcomes After ACL Reconstruction Versus Primary Repair 45 Translation Available

Not yet recruiting

Clinical Trial NCT07318272 is an observational study for Anterior Cruciate Ligament (ACL) Tear, Anterior Cruciate Ligament Reconstruction, Isokinetic Test and is currently not yet recruiting. Enrollment is planned to begin on January 1, 2026 and continue until the study accrues 45 participants. Led by Gazi University, this study is expected to complete by August 30, 2027. The latest data from ClinicalTrials.gov was last updated on January 5, 2026.

Brief 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, refi...Show More

Detailed Description

The anterior cruciate ligament (ACL), one of the key stabilizers of the knee joint, plays a crucial role in maintaining both anteroposterior and rotational stability. The increasing popularity of recreational and competitive sports has contributed to a rising incidence of ACL injuries in recent years. Until the late 1980s, primary repair was widely accepted as the standard treatment for ACL injuries. Although short-t...Show More

Official Title

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

Conditions

Anterior Cruciate Ligament (ACL) TearAnterior Cruciate Ligament ReconstructionIsokinetic Test

Publications

Hoogeslag RAG, Brouwer RW, Boer BC, de Vries AJ, Huis In 't Veld R. Acute Anterior Cruciate Ligament Rupture: Repair or Reconstruction? Two-Year Results of a Randomized Controlled Clinical Trial. Am J Sports Med. 2019 Mar;47(3):567-577. doi: 10.1177/0363546519825878.

Other Study IDs

Gazi2025

NCT ID Number

NCT07318272

Start Date (Actual)

2026-01-01

Last Update Posted

2026-01-05

Completion Date (Estimated)

2027-08-30

Enrollment (Estimated)

Study Type

Observational

Status

Not yet recruiting

Keywords

ACL Injury
Anterior Cruciate Ligament
ACL Reconstruction
ACL Primary Repair
Postoperative Outcomes
Muscle Oxygenation
Isokinetic Testing

Arms / Interventions

Participant Group/Arm	Intervention/Treatment
ACL Reconstruction Group Demographic data, injury history, and surgical details will be recorded for all participants. The International Physical Activity Questionnaire, IKDC, and ACL-RSI scales will be administered. Assessments will be completed over two days. Isokinetic knee flexor/extensor strength, fatigue protocol, and H/Q ratios will be measured using the Cybex Norm dynamometer. Quadriceps and hamstring muscle oxygenation will be asses...Show More	N/A
Primary ACL Repair Group Demographic data, injury history, and surgical details will be recorded for all participants. The International Physical Activity Questionnaire, IKDC, and ACL-RSI scales will be administered. Assessments will be completed over two days. Isokinetic knee flexor/extensor strength, fatigue protocol, and H/Q ratios will be measured using the Cybex Norm dynamometer. Quadriceps and hamstring muscle oxygenation will be asses...Show More	N/A
Healthy Control Group Demographic data and physical activity levels will be recorded for healthy participants. All individuals will complete the International Physical Activity Questionnaire, IKDC, and ACL-RSI scales. Assessments will be conducted over two days. Knee flexor/extensor strength and H/Q ratios will be measured using the Cybex Norm isokinetic dynamometer. Quadriceps and hamstring muscle oxygenation will be assessed with the Tr...Show More	N/A

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Peak Torque (Isokinetic Strength)	Peak torque of the knee flexor and extensor muscles will be measured using an isokinetic dynamometer (Cybex NORM® isokinetic dynamometer, Humac, CA, USA). Measurements will be performed in the following modes: concentric contraction at 60°/s, eccentric contraction at 60°/s, concentric contraction at 180°/s, and concentric contraction at 300°/s. Peak torque values will be recorded for each testing velocity and contraction mode and expressed in Newton-meters (Nm). Unit of Measure: Newton-meter (Nm)	First Day
Extremity Symmetry Index (ESI)	Extremity Symmetry Index will be calculated by comparing the involved and uninvolved limbs using peak torque values obtained from isokinetic testing. Unit of Measure: Percentage (%)	First day
Conventional Hamstring-to-Quadriceps Ratio (H/Q Ratio)	The conventional H/Q ratio will be calculated as the ratio of concentric hamstring peak torque to concentric quadriceps peak torque. Unit of Measure: Ratio	First day
Functional Hamstring-to-Quadriceps Ratio	The functional H/Q ratio will be calculated as the ratio of eccentric hamstring peak torque to concentric quadriceps peak torque. Unit of Measure: Ratio	First day
Functional Range	Functional range will be defined as the angular range in which at least 85% of peak torque is maintained during isokinetic testing. Unit of Measure: Percentage (%)	First Day
Fatigue-Induced Peak Torque Decline	Fatigue-related performance decline will be calculated as the percentage decrease in peak torque following a 33-repetition isokinetic fatigue protocol at 300°/s. Unit of Measure: Percentage (%)	First Day
Muscle Oxygenation	Muscle oxygenation will be assessed using the Train.Red FYER wireless near-infrared spectroscopy (NIRS) system (Train.Red, Gelderland, Netherlands). The device provides continuous, non-invasive measurements of tissue oxygen saturation (StO₂) and the oxy-deoxyhemoglobin difference (HbDiff). Sensors will be placed over the quadriceps and hamstring muscles following SENIAM guidelines. Muscle oxygenation will be recorded before and immediately after the isokinetic fatigue protocol to evaluate changes in local oxygen utilization and metabolic stress.	First Day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Knee Joint Proprioception	Knee proprioception will be assessed using an active joint repositioning test performed on the Cybex NORM® isokinetic system (Humac, CA, USA). Participants will actively reproduce a target angle (30° knee flexion) starting from 90° flexion. Three trials will be recorded, and the absolute angular error will be calculated as the mean difference between the target angle and the reproduced angles. This measure reflects the accuracy of joint position sense and will be used to evaluate proprioceptive function.	First Day
Single Leg Balance	Postural control will be assessed using the KFORCE Plates force platform (Kinvent, Montpellier, France). Participants will perform a single-leg balance task, and Center of Pressure (CoP)-based variables such as mean CoP velocity, path length, sway area, and stabilization time will be recorded. Measurements will be obtained under standardized testing conditions for both limbs.	Second Day
Single Leg Landing	Dynamic stability will be assessed using the KFORCE Plates force platform. Participants will perform a single-leg landing task, and Center of Pressure (CoP)-based variables including stabilization time, CoP displacement, sway area, and CoP velocity will be analyzed. This measure evaluates the participant's ability to achieve stable posture following landing.	Second Day
Knee Laxity	Knee anterior laxity will be assessed using the GNRB® arthrometer at 20° of knee flexion. The primary outcome variable will be Anterior Tibial Translation (ATT) measured in millimeters under standardized forces (134 N and 200 N). The side-to-side difference in ATT and the slope value (stiffness index) will also be recorded to evaluate anterior cruciate ligament integrity. These parameters provide an objective and quantitative measure of ligamentous stability.	First Day
IKDC Subjective Knee Evaluation	The International Knee Documentation Committee (IKDC) Subjective Knee Evaluation Form will be used to assess patient-reported knee symptoms, function, and sports activity levels. Scores range from 0 to 100, with higher scores indicating better knee function and fewer symptoms. This measure provides a validated assessment of functional recovery following ACL surgery.	First Day
ACL-RSI (Return to Sport Index)	The Anterior Cruciate Ligament-Return to Sport after Injury (ACL-RSI) scale will be administered to evaluate psychological readiness to return to sport. The 12-item scale assesses emotions, confidence, and risk appraisal related to returning to physical activity. Scores range from 0 to 100, with higher scores indicating greater psychological readiness. This measure allows comparison of psychological recovery after ACL reconstruction and primary repair.	First Day

Participation Assistant

Eligibility Criteria

Eligible Ages

Adult

Minimum Age

18 Years

Eligible Sexes

All

Accepts Healthy Volunteers

Yes

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

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

Gazi University

Study Responsible Party

Dudu Özdemir, Principal Investigator, MSc., Gazi University

Study Central Contact

Contact: Dudu Ozdemir Can, Msc, 90 5534448492, [email protected]

1 Study Locations in 1 Countries

Turkey (Türkiye)

Çankaya

Gazi University Faculty of Health Sciences Department of Physiotherapy and Rehabilitation, Ankara, Çankaya, 06490, Turkey (Türkiye)

Dudu Ozdemir Can, MSc, Contact, 90 5534448492, [email protected]