Anterior Cruciate Ligament Reconstruction RehabilitationGRAFT-ACLNCT07523854
Effect of Graft Type on Knee Muscle Strength After ACL Reconstruction
An observational study of Anterior Cruciate Ligament Reconstruction Rehabilitation and Strength Outcomes, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
This prospective observational study will compare recovery after anterior cruciate ligament reconstruction using quadriceps tendon autograft or hamstring tendon autograft. The main goal is to examine differences in knee muscle strength recovery during the early and mid-term postoperative period. Read more about this study
- Who is it for?
- Ages 13 to 45 years
- Conditions the study is for
- Anterior Cruciate Ligament Reconstruction Rehabilitation, Strength Outcomes, Anterior Cruciate Ligament (ACL) Reconstruction Surgery
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 23 Jan 2026to 25 Feb 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 45 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Participants will be patients with anterior cruciate ligament reconstruction using either quadriceps tendon autograft or hamstring tendon autograft who are referred by an orthopedist to the Hacettepe University Sports Health Unit, meet the eligibility criteria, and provide voluntary consent
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Hacettepe University
Ankara, 06100
Volga Bayrakci Tunay, Prof. Dr., Phd, 312-305-25-33-186 ext. +90, volgatunay@hacettepe.edu.tr
About this study
Official title: Effect of Graft Type on Knee Muscle Strength Development After Anterior Cruciate Ligament Reconstruction
This prospective observational study will compare recovery after anterior cruciate ligament reconstruction using quadriceps tendon autograft or hamstring tendon autograft. The main goal is to examine differences in knee muscle strength recovery during the early and mid-term postoperative period. Participants aged 13 to 45 years who undergo unilateral ACL reconstruction and meet the eligibility criteria will be followed at Hacettepe University. Knee extensor and flexor strength will be assessed using isometric testing at postoperative weeks 4, 8, and 12 and month 6, and with isokinetic concentric testing at months 3 and 6. Functional outcomes and kinesiophobia will also be evaluated at month 6 using IKDC, KOOS, and the Tampa Scale for Kinesiophobia. All participants will receive the same standard postoperative rehabilitation program under physiotherapist supervision. The study aims to clarify whether graft type is associated with different patterns of muscle strength recovery and functional improvement after ACL reconstruction
Read the 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
- Conditions
- Anterior Cruciate Ligament Reconstruction Rehabilitation, Strength Outcomes, Anterior Cruciate Ligament (ACL) Reconstruction Surgery
- Keywords
- ACL reconstruction, quadriceps tendon autograft, hamstring tendon autograft, knee muscle strength, rehabilitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. | |
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Isometric Quadriceps Muscle Strengt
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).
Measured: Postoperative weeks 4, 8, and 12, and month 6
Isometric Hamstring Muscle Strength
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)
Measured: Postoperative weeks 4, 8, and 12, and month 6
Secondary outcomes (5)
Concentric Quadriceps- Hamstring Peak Torque at 60°/s and 180°/s
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).
Measured: Postoperative months 3 and 6
Limb Symmetry Index
Limb Symmetry Index calculated from isokinetic peak torque values as operated limb / contralateral limb × 100.
Measured: Postoperative months 3 and 6
International Knee Documentation Committee Subjective Knee Form Score
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.
Measured: Postoperative month 6
Knee Injury and Osteoarthritis Outcome Score
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.
Measured: Postoperative month 6
Tampa Scale for Kinesiophobia Score
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)
Measured: Postoperative month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2026
- Study start23 Jan 2026
- Primary completion25 Jan 2027 (estimated)
- Study completion25 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anterior Cruciate Ligament Reconstruction RehabilitationStudies of the same condition, open and under way.
- More trials run by Hacettepe UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kubra Caylan Gurses, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07523854
- Sponsor's protocol ID
- FTREK25/175
- Acronym
- GRAFT-ACL
- Status last verified
- Apr 2026
- First submitted
- 5 Apr 2026
- Last updated
- 15 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Graft Type on Knee Muscle Strength Development After Anterior Cruciate Ligament Reconstruction
- ClinicalTrials.gov ID
- NCT07523854
- Acronym / sponsor ID
- GRAFT-ACL / FTREK25/175
- Conditions
- Anterior Cruciate Ligament Reconstruction Rehabilitation, Strength Outcomes, Anterior Cruciate Ligament (ACL) Reconstruction Surgery
- Keywords
- ACL reconstruction, quadriceps tendon autograft, hamstring tendon autograft, knee muscle strength, rehabilitation
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 23 Jan 2026 (actual)
- Primary completion
- 25 Jan 2027 (estimated)
- Study completion
- 25 Feb 2027 (estimated)
- First posted
- 13 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This prospective observational study will compare recovery after anterior cruciate ligament reconstruction using quadriceps tendon autograft or hamstring tendon autograft. The main goal is to examine differences in knee muscle strength recovery during the early and mid-term postoperative period. Participants aged 13 to 45 years who undergo unilateral ACL reconstruction and meet the eligibility criteria will be followed at Hacettepe University. Knee extensor and flexor strength will be assessed using isometric testing at postoperative weeks 4, 8, and 12 and month 6, and with isokinetic concentric testing at months 3 and 6. Functional outcomes and kinesiophobia will also be evaluated at month 6 using IKDC, KOOS, and the Tampa Scale for Kinesiophobia. All participants will receive the same standard postoperative rehabilitation program under physiotherapist supervision. The study aims to clarify whether graft type is associated with different patterns of muscle strength recovery and functional improvement after ACL reconstruction
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
| 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. |
Who may qualify
- Ages
- 13 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Participants will be patients with anterior cruciate ligament reconstruction using either quadriceps tendon autograft or hamstring tendon autograft who are referred by an orthopedist to the Hacettepe University Sports Health Unit, meet the eligibility criteria, and provide voluntary consent
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Isometric Quadriceps Muscle Strengt
Time frame: Postoperative weeks 4, 8, and 12, and month 6
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).
Isometric Hamstring Muscle Strength
Time frame: Postoperative weeks 4, 8, and 12, and month 6
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)
5 secondary outcomes
Concentric Quadriceps- Hamstring Peak Torque at 60°/s and 180°/s
Time frame: Postoperative months 3 and 6
Limb Symmetry Index
Time frame: Postoperative months 3 and 6
International Knee Documentation Committee Subjective Knee Form Score
Time frame: Postoperative month 6
Knee Injury and Osteoarthritis Outcome Score
Time frame: Postoperative month 6
Tampa Scale for Kinesiophobia Score
Time frame: Postoperative month 6
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anterior Cruciate Ligament Reconstruction Rehabilitation and Strength Outcomes, run by Hacettepe University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Volga Bayrakci Tunay Bayrakci Tunay, Phd (+90 532 354 7626, volgamel@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Isometric Quadriceps Muscle Strengt (time frame: Postoperative weeks 4, 8, and 12, and month 6). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2026.