- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07523854
Effect of Graft Type on Knee Muscle Strength After ACL Reconstruction (GRAFT-ACL)
Effect of Graft Type on Knee Muscle Strength Development After Anterior Cruciate Ligament Reconstruction
Study Overview
Status
Detailed Description
Anterior cruciate ligament reconstruction is commonly performed in physically active individuals, and graft choice may influence postoperative muscle strength recovery, donor-site morbidity, and return to function. Although quadriceps tendon and hamstring tendon autografts are both widely used, previous studies have mainly focused on longer-term functional outcomes, while direct serial comparisons of early postoperative strength recovery remain limited. This study was designed to address that gap by prospectively comparing early and mid-term muscle strength profiles and 6-month clinical outcomes between these two autograft groups.
This is a prospective clinical observational study conducted at the Department of Sports Physiotherapy and Rehabilitation, Hacettepe University Faculty of Physical Therapy and Rehabilitation. The planned sample size is 34 participants, with 17 participants in each graft group. Eligible participants are individuals aged 13 to 45 years who undergo unilateral anterior cruciate ligament reconstruction with either a quadriceps tendon autograft or a hamstring tendon autograft, have a Tegner Activity Score of 5 or higher, and consent to participate. Key exclusion criteria include patellar tendon or allograft reconstruction, revision surgery, multiple ligament injuries, major collateral ligament injury, marked cartilage lesions, major systemic or neurologic disease, and inability to adhere to rehabilitation.
All participants will be followed prospectively and will receive a standardized postoperative rehabilitation program supervised by a physiotherapist twice weekly from the first postoperative week through week 12, together with a home exercise program. The rehabilitation protocol is phase- and criterion-based. Early rehabilitation focuses on pain and edema reduction, restoration of knee range of motion, quadriceps activation, and gait recovery. Later phases progressively add neuromuscular, balance, lumbopelvic stabilization, closed-chain and open-chain strengthening, and sport-specific exercises. Participants with hamstring tendon grafts begin resisted hamstring open-chain exercises from postoperative week 8, while resisted quadriceps open-chain exercises begin from postoperative week 4 within a limited range and later progress to full range as tolerated.
Outcome assessment includes demographic and clinical data collection, pain ratings, knee muscle strength testing, and patient-reported outcomes. Isometric quadriceps and hamstring strength will be measured at postoperative weeks 4, 8, and 12 and month 6 using an IsoMed 2000 dynamometer with the knee positioned at 60 degrees of flexion. After submaximal familiarization trials, participants will perform three 5-second maximal contractions, and the highest value normalized to body weight will be recorded. Isokinetic concentric quadriceps and hamstring strength will be assessed at months 3 and 6 at angular velocities of 60°/s for 5 repetitions and 180°/s for 15 repetitions. Peak torque normalized to body weight and limb symmetry index will be calculated. Functional outcomes will be assessed at month 6 using the International Knee Documentation Committee Subjective Knee Form and the Knee Injury and Osteoarthritis Outcome Score, and kinesiophobia will be evaluated using the Tampa Scale for Kinesiophobia.
The primary aim is to compare postoperative quadriceps and hamstring isometric strength recovery and functional outcomes between quadriceps tendon and hamstring tendon autograft groups across postoperative weeks 4, 8, and 12 and month 6. The secondary aim is to compare knee symptoms, function, and fear of movement at month 6 and to interpret these findings together with strength asymmetries. The study is considered low risk; possible discomfort is limited mainly to temporary pain, fatigue, or muscle strain during rehabilitation or strength testing. To minimize risk, all procedures are supervised by experienced physiotherapists, warm-up and stretching are performed before testing, symptoms are monitored, and testing is stopped if clinically significant pain occurs. Participant data will be coded and analyzed in anonymized form
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Volga Bayrakci Tunay Bayrakci Tunay, Phd
- Phone Number: +90 532 354 7626
- Email: volgamel@yahoo.com
Study Locations
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Ankara, Turkey (Türkiye), 06100
- Recruiting
- Hacettepe University
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Contact:
- Volga Bayrakci Tunay, Prof. Dr., Phd
- Phone Number: +90 312-305-25-33-186
- Email: volgatunay@hacettepe.edu.tr
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Age 13 to 45 years
- Undergoing anterior cruciate ligament reconstruction with either hamstring tendon autograft or quadriceps tendon autograft
- Unilateral anterior cruciate ligament injury
- Complete ACL tear with accompanying minimal collateral ligament injury and first-degree meniscal tear
- Tegner Activity Score of 5 or higher
- Willingness to participate in the study
Exclusion Criteria:
- Anterior cruciate ligament reconstruction with patellar tendon autograft or allograft
- Revision surgery
- Systemic or neurological disease
- Multiple ligament injuries
- Grade III lateral or medial collateral ligament tear or significant articular cartilage lesion
- Failure to regularly attend the rehabilitation program during the first 3 postoperative months
- History of lower extremity injury in the contralateral limb within the last 12 months
- Hypertension, cardiovascular disease, peripheral vascular disease, history of deep vein thrombosis, neurological disease, systemic inflammation, diabetes, cancer, or obesity
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Quadriceps Tendon Autograft
Participants who underwent anterior cruciate ligament reconstruction with quadriceps tendon autograft and were followed prospectively with standardized rehabilitation and serial strength assessments.
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Hamstring Tendon Autograft
Participants who underwent anterior cruciate ligament reconstruction with hamstring tendon autograft and were followed prospectively with standardized rehabilitation and serial strength assessments.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Isometric Quadriceps Muscle Strengt
Time Frame: Postoperative weeks 4, 8, and 12, and month 6
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Maximum voluntary isometric quadriceps strength measured with an IsoMed 2000 dynamometer at 60° of knee flexion.
The highest value from 3 maximal 5-second contractions will be recorded and normalized to body weight (Nm/kg).
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Postoperative weeks 4, 8, and 12, and month 6
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Isometric Hamstring Muscle Strength
Time Frame: Postoperative weeks 4, 8, and 12, and month 6
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Maximum voluntary isometric hamstring strength measured with an IsoMed 2000 dynamometer at 60° of knee flexion.
The highest value from 3 maximal 5-second contractions will be recorded and normalized to body weight (Nm/kg)
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Postoperative weeks 4, 8, and 12, and month 6
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Concentric Quadriceps- Hamstring Peak Torque at 60°/s and 180°/s
Time Frame: Postoperative months 3 and 6
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Concentric quadriceps and hamstring peak torque measured with an IsoMed 2000 dynamometer during isokinetic testing at 60°/s for 5 repetitions and 180°/s for 15 repetitions.
Values will be normalized to body weight (Nm/kg).
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Postoperative months 3 and 6
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Limb Symmetry Index
Time Frame: Postoperative months 3 and 6
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Limb Symmetry Index calculated from isokinetic peak torque values as operated limb / contralateral limb × 100.
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Postoperative months 3 and 6
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International Knee Documentation Committee Subjective Knee Form Score
Time Frame: Postoperative month 6
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Patient-reported knee symptoms, function, and sports activity assessed using the IKDC Subjective Knee Form.
Scores range from 0 to 100, with higher scores indicating better knee function.
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Postoperative month 6
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Knee Injury and Osteoarthritis Outcome Score
Time Frame: Postoperative month 6
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Patient-reported knee outcomes assessed using the KOOS, including pain, symptoms, activities of daily living, sport and recreation, and knee-related quality of life.
Scores range from 0 to 100, with higher scores indicating better status.
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Postoperative month 6
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Tampa Scale for Kinesiophobia Score
Time Frame: Postoperative month 6
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Fear of movement assess using the Tampa Scale for Kinesiophobia.
Higher scores indicate greater kinesiophobia.
Tampa Scale for Kinesiophobia (TSK) total score (17 to 68): higher scores indicate greater kinesiophobia (worse outcome)
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Postoperative month 6
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- FTREK25/175
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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