- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07671729
Quadriceps Tendon vs Peroneus Longus Tendon in ACL Reconstruction
A Prospective Randomized Clinical Trial Comparing Quadriceps Tendon and Peroneus Longus Tendon Autografts in Anterior Cruciate Ligament Reconstruction: Clinical, Functional, and Gait Analysis Outcomes
Study Overview
Status
Detailed Description
Anterior cruciate ligament (ACL) reconstruction is one of the most commonly performed orthopedic procedures for restoring knee stability and enabling return to sports activities after ACL injury. Various autograft options have been described for ACL reconstruction, including hamstring tendon, bone-patellar tendon-bone, quadriceps tendon, and more recently, peroneus longus tendon grafts. Each graft option has unique biomechanical characteristics, advantages, and potential donor site morbidities.
Quadriceps tendon autografts have gained increasing popularity because of their adequate graft diameter, favorable biomechanical properties, and relatively low donor site complications. Peroneus longus tendon autografts have also emerged as a promising alternative graft source with satisfactory clinical outcomes and sufficient graft size. However, concerns remain regarding donor site morbidity, particularly potential effects on ankle muscle strength and ankle function following peroneus longus tendon harvesting.
This prospective randomized study aims to compare quadriceps tendon and peroneus longus tendon autografts in patients undergoing primary ACL reconstruction. Patients will be randomly assigned into two groups according to graft type. Clinical evaluations, functional knee scores, return-to-sport outcomes, ankle muscle strength assessments, ankle-related functional scores, and gait analysis parameters will be assessed during postoperative follow-up.
Follow-up evaluations will be performed at 6 months and 12 months after surgery. The findings of this study are expected to contribute to graft selection strategies in ACL reconstruction by providing comparative data regarding clinical outcomes, functional recovery, gait characteristics, and donor site morbidity.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Besiktas
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Istanbul, Besiktas, Turkey (Türkiye), 34349
- Recruiting
- Acibadem Fulya Hospital, Sport Medicine Center
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Contact:
- Tunay Erden, M.D.
- Phone Number: +905546289045
- Email: tunayerden@gmail.com
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Patients diagnosed with anterior cruciate ligament rupture
- Patients scheduled for primary anterior cruciate ligament reconstruction
- Age between 18 and 50 years
- Ability to provide informed consent
- Willingness to comply with postoperative rehabilitation and follow-up evaluations
Exclusion Criteria:
- Previous ligament reconstruction surgery on the affected knee
- Multi-ligament knee injuries requiring additional ligament reconstruction
- Severe osteoarthritis of the knee
- Revision anterior cruciate ligament reconstruction
- Neuromuscular disorders affecting lower extremity function
- Active infection
- Inability to comply with follow-up protocol
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Quadriceps Tendon Autograft
Patients undergoing anterior cruciate ligament reconstruction using quadriceps tendon autograft.
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Anterior cruciate ligament reconstruction performed using quadriceps tendon autograft.
|
|
Experimental: Peroneus Longus Tendon Autograft
Patients undergoing anterior cruciate ligament reconstruction using peroneus longus tendon autograft.
|
Anterior cruciate ligament reconstruction performed using peroneus longus tendon autograft.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
International Knee Documentation Committee (IKDC) Subjective Knee Score
Time Frame: 12 months postoperatively
|
Comparison of postoperative subjective knee function between quadriceps tendon and peroneus longus tendon autograft groups using the International Knee Documentation Committee (IKDC) subjective knee evaluation form.
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12 months postoperatively
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Return to Sport Rate
Time Frame: Assessment of return to pre-injury level of sports activity following anterior cruciate ligament reconstruction.
|
6 and 12 months postoperatively
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Assessment of return to pre-injury level of sports activity following anterior cruciate ligament reconstruction.
|
|
Ankle Plantar Flexion Strength
Time Frame: 6 and 12 months postoperatively
|
Isokinetic ankle plantar flexion strength will be evaluated using an isokinetic dynamometer.
Peak torque (Nm) during plantar flexion will be recorded and compared between study groups.
|
6 and 12 months postoperatively
|
|
Ankle Dorsiflexion Strength
Time Frame: 6 and 12 months postoperatively
|
Isokinetic ankle dorsiflexion strength will be evaluated using an isokinetic dynamometer.
Peak torque (Nm) during dorsiflexion will be recorded and compared between study groups.
|
6 and 12 months postoperatively
|
|
Ankle Inversion Strength
Time Frame: 6 and 12 months postoperatively
|
Isokinetic ankle inversion strength will be evaluated using an isokinetic dynamometer.
Peak torque (Nm) during inversion will be recorded and compared between study groups.
|
6 and 12 months postoperatively
|
|
Ankle Eversion Strength
Time Frame: 6 and 12 months postoperatively
|
Isokinetic ankle eversion strength will be evaluated using an isokinetic dynamometer.
Peak torque (Nm) during eversion will be recorded and compared between study groups.
|
6 and 12 months postoperatively
|
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Ankle Rotational Strength
Time Frame: 6 and 12 months postoperatively
|
Isokinetic ankle rotational strength will be evaluated using an isokinetic dynamometer.
Peak torque (Nm) during rotational movements will be recorded and compared between study groups.
|
6 and 12 months postoperatively
|
|
Ground Reaction Force
Time Frame: 6 and 12 months postoperatively
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Lower extremity biomechanical performance will be assessed using the VALD ForceDecks dual force plate system.
Ground reaction force (N) during standardized standing and functional testing tasks will be recorded and compared between study groups.
|
6 and 12 months postoperatively
|
|
Force Asymmetry
Time Frame: 6 and 12 months postoperatively
|
Lower extremity biomechanical performance will be assessed using the VALD ForceDecks dual force plate system.
Force asymmetry (%) during standardized standing and functional testing tasks will be recorded and compared between study groups.
|
6 and 12 months postoperatively
|
|
Weight Distribution
Time Frame: 6 and 12 months postoperatively
|
Lower extremity biomechanical performance will be assessed using the VALD ForceDecks dual force plate system.
Weight distribution (%) during standardized standing and functional testing tasks will be recorded and compared between study groups.
|
6 and 12 months postoperatively
|
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- Quadriceps vs PL
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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Clinical Trials on Anterior Cruciate Ligament Reconstruction Using Quadriceps Tendon Autograft
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Muzaffer AgirAcibadem UniversityRecruitingAnterior Cruciate Ligament Injuries | Athletic Injuries | Tendon Graft; ComplicationsTurkey
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Artromedical Konrad Malinowski ClinicRecruitingAnterior Cruciate Ligament Injuries | Anterior Cruciate Ligament Rupture | Anterior Cruciate Ligament TearPoland
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Universidad de GranadaCompletedKnee Injuries and DisordersSpain
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Instituto Nacional de RehabilitacionEnrolling by invitationAnterior Cruciate Ligament RuptureMexico
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University of Sao PauloUnknownComplete Tear, Knee, Anterior Cruciate Ligament | Rupture of Anterior Cruciate LigamentBrazil
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Peking University Third HospitalUnknownRupture of Anterior Cruciate Ligament
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Centre Hospitalier Universitaire de NīmesTerminatedAnterior Cruciate Ligament InjuryFrance
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Vita CareUnknownAnterior Cruciate Ligament InjuryBrazil
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Universitaire Ziekenhuizen KU LeuvenCentre Hospitalier Universitaire de Liege; Federaal Kenniscentrum voor de GezondheidszorgCompletedAnterior Cruciate Ligament InjuriesBelgium
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Universitaire Ziekenhuizen KU LeuvenCentre Hospitalier Universitaire de Liege; Belgian Health Care Knowledge Centre and other collaboratorsRecruiting