- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving 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
Studieoversikt
Status
Detaljert beskrivelse
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
Registrering (Antatt)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
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Besiktas
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Istanbul, Besiktas, Tyrkia (Türkiye), 34349
- Rekruttering
- Acibadem Fulya Hospital, Sport Medicine Center
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Ta kontakt med:
- Tunay Erden, M.D.
- Telefonnummer: +905546289045
- E-post: tunayerden@gmail.com
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
Tar imot friske frivillige
Beskrivelse
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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: 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.
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Eksperimentell: Peroneus Longus Tendon Autograft
Patients undergoing anterior cruciate ligament reconstruction using peroneus longus tendon autograft.
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Anterior cruciate ligament reconstruction performed using peroneus longus tendon autograft.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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International Knee Documentation Committee (IKDC) Subjective Knee Score
Tidsramme: 12 months postoperatively
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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
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Return to Sport Rate
Tidsramme: Assessment of return to pre-injury level of sports activity following anterior cruciate ligament reconstruction.
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6 and 12 months postoperatively
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Assessment of return to pre-injury level of sports activity following anterior cruciate ligament reconstruction.
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Ankle Plantar Flexion Strength
Tidsramme: 6 and 12 months postoperatively
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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.
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6 and 12 months postoperatively
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Ankle Dorsiflexion Strength
Tidsramme: 6 and 12 months postoperatively
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Isokinetic ankle dorsiflexion strength will be evaluated using an isokinetic dynamometer.
Peak torque (Nm) during dorsiflexion will be recorded and compared between study groups.
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6 and 12 months postoperatively
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Ankle Inversion Strength
Tidsramme: 6 and 12 months postoperatively
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Isokinetic ankle inversion strength will be evaluated using an isokinetic dynamometer.
Peak torque (Nm) during inversion will be recorded and compared between study groups.
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6 and 12 months postoperatively
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Ankle Eversion Strength
Tidsramme: 6 and 12 months postoperatively
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Isokinetic ankle eversion strength will be evaluated using an isokinetic dynamometer.
Peak torque (Nm) during eversion will be recorded and compared between study groups.
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6 and 12 months postoperatively
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Ankle Rotational Strength
Tidsramme: 6 and 12 months postoperatively
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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.
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6 and 12 months postoperatively
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Ground Reaction Force
Tidsramme: 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.
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6 and 12 months postoperatively
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Force Asymmetry
Tidsramme: 6 and 12 months postoperatively
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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.
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6 and 12 months postoperatively
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Weight Distribution
Tidsramme: 6 and 12 months postoperatively
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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.
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6 and 12 months postoperatively
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Samarbeidspartnere og etterforskere
Sponsor
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
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