NCT07671729

Brief Summary

This prospective randomized clinical trial aims to compare quadriceps tendon and peroneus longus tendon autografts in anterior cruciate ligament reconstruction. Patients with anterior cruciate ligament injury undergoing primary reconstruction surgery will be randomly assigned to one of the two graft groups. Clinical examination findings, return-to-sport outcomes, ankle muscle strength, ankle-related functional scores, and gait analysis parameters will be evaluated at 6 months and 12 months postoperatively. The study aims to investigate both knee-related functional outcomes and donor site morbidity associated with graft harvesting techniques.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
16mo left

Started May 2026

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress16%
May 2026Dec 2027

Study Start

First participant enrolled

May 1, 2026

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

June 12, 2026

Completed
14 days until next milestone

First Posted

Study publicly available on registry

June 26, 2026

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2027

Expected
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2027

Last Updated

June 26, 2026

Status Verified

April 1, 2026

Enrollment Period

1 year

First QC Date

June 12, 2026

Last Update Submit

June 23, 2026

Conditions

Anterior Cruciate Ligament InjuryAnterior Cruciate Ligament Rupture

Keywords

ACL reconstructionAnterior cruciate ligamentQuadriceps tendon autograftPeroneus longus tendon autograftGait analysisReturn to sportKnee stabilityAnkle muscle strengthFunctional outcomesRandomized controlled trial

Outcome Measures

Primary Outcomes (1)

  • International Knee Documentation Committee (IKDC) Subjective Knee Score

    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

Secondary Outcomes (9)

  • Return to Sport Rate

    Assessment of return to pre-injury level of sports activity following anterior cruciate ligament reconstruction.

  • Ankle Plantar Flexion Strength

    6 and 12 months postoperatively

  • Ankle Dorsiflexion Strength

    6 and 12 months postoperatively

  • Ankle Inversion Strength

    6 and 12 months postoperatively

  • Ankle Eversion Strength

    6 and 12 months postoperatively

  • +4 more secondary outcomes

Study Arms (2)

Quadriceps Tendon Autograft

EXPERIMENTAL

Patients undergoing anterior cruciate ligament reconstruction using quadriceps tendon autograft.

Procedure: Anterior Cruciate Ligament Reconstruction Using Quadriceps Tendon Autograft

Peroneus Longus Tendon Autograft

EXPERIMENTAL

Patients undergoing anterior cruciate ligament reconstruction using peroneus longus tendon autograft.

Procedure: Anterior Cruciate Ligament Reconstruction Using Peroneus Longus Tendon Autograft

Interventions

Anterior Cruciate Ligament Reconstruction Using Peroneus Longus Tendon AutograftPROCEDURE

Anterior cruciate ligament reconstruction performed using peroneus longus tendon autograft.

Peroneus Longus Tendon Autograft
Anterior Cruciate Ligament Reconstruction Using Quadriceps Tendon AutograftPROCEDURE

Anterior cruciate ligament reconstruction performed using quadriceps tendon autograft.

Quadriceps Tendon Autograft

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Acibadem Fulya Hospital, Sport Medicine Center

Istanbul, Besiktas, 34349, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries

Condition Hierarchy (Ancestors)

Knee InjuriesLeg InjuriesWounds and Injuries

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Participants will be randomly assigned to undergo anterior cruciate ligament reconstruction using either quadriceps tendon autograft or peroneus longus tendon autograft in parallel groups.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Orthopaedic Surgeon, Department of Orthopaedics and Traumatology

Study Record Dates

First Submitted

June 12, 2026

First Posted

June 26, 2026

Study Start

May 1, 2026

Primary Completion (Estimated)

May 1, 2027

Study Completion (Estimated)

December 1, 2027

Last Updated

June 26, 2026

Record last verified: 2026-04

Locations

TU(1)