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
Studie Overzicht
Toestand
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Geschat)
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
-
-
Besiktas
-
Istanbul, Besiktas, Turkije (Türkiye), 34349
- Werving
- Acibadem Fulya Hospital, Sport Medicine Center
-
Contact:
- Tunay Erden, M.D.
- Telefoonnummer: +905546289045
- E-mail: tunayerden@gmail.com
-
-
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
Accepteert gezonde vrijwilligers
Beschrijving
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Experimenteel: Quadriceps Tendon Autograft
Patients undergoing anterior cruciate ligament reconstruction using quadriceps tendon autograft.
|
Anterior cruciate ligament reconstruction performed using quadriceps tendon autograft.
|
|
Experimenteel: 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.
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
International Knee Documentation Committee (IKDC) Subjective Knee Score
Tijdsspanne: 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.
|
12 months postoperatively
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Return to Sport Rate
Tijdsspanne: Assessment of return to pre-injury level of sports activity following anterior cruciate ligament reconstruction.
|
6 and 12 months postoperatively
|
Assessment of return to pre-injury level of sports activity following anterior cruciate ligament reconstruction.
|
|
Ankle Plantar Flexion Strength
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
|
|
Ankle Rotational Strength
Tijdsspanne: 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
Tijdsspanne: 6 and 12 months postoperatively
|
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
Tijdsspanne: 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
Tijdsspanne: 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
|
Medewerkers en onderzoekers
Sponsor
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- Quadriceps vs PL
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .