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RecruitingNCT06617559Updated Sep 27, 2024

Comparison of Autologous Quadriceps and Hamstring Tendon Grafts in Anterior Cruciate Ligament Reconstruction

An interventional study of Anterior Cruciate Ligament Reconstruction with Quadriceps Autograft and Anterior Cruciate Ligament Reconstruction with Hamstring Autograft in Anterior Cruciate Ligament Injuries, Athletic Injuries and Tendon Graft; Complications, sponsored by Muzaffer Agir. Recruiting at 1 site in Turkey. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-09-27.

Sponsored by Muzaffer Agir · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Oct 2025, 1 year 1 month ago, but the record still lists the study as recruiting.
  • Registered 4 months after the study started (first participant enrolled May 2024, registered Sep 2024).
  • Started May 2024; still recruiting 2 years 5 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
25
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

With the recent technological advancements, the use of the quadriceps tendon with an all-inside technique has come to the forefront, and large-scale research has focused especially on quadriceps tendon grafts. Clinical study results have reported that the outcomes are similar to those of patellar tendon grafts and either equivalent or superior to hamstring tendon grafts.

The aim of this study is the prospective comparison of the clinical and radiological outcomes of patients who underwent anterior cruciate ligament (ACL) reconstruction with autologous hamstring and quadriceps tendon grafts.

02

Conditions studied

  • Anterior Cruciate Ligament Injuries
  • Athletic Injuries
  • Tendon Graft; Complications

Keywords

  • anterior cruciate ligament reconstruction
  • hamstring tendons
  • athletic injuries
03

In context

Anterior Cruciate Ligament Injuries

625 studies on the registry are indexed under Anterior Cruciate Ligament Injuries; 192 are open to participants now.

This study's planned enrollment of 25 is below the median of 56 across 458 interventional studies indexed under Anterior Cruciate Ligament Injuries.

Browse Anterior Cruciate Ligament Injuries studies →

Lead sponsor

This is the only study on the registry with Muzaffer Agir as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Elite athletes
  • Amateur athletes
  • Anterior cruciate ligament injury

Exclusion criteria

Exclusion Criteria:

  • Revision surgery
  • Another ligament injury ( medial collateral ligament, lateral collateral ligament, etc.. )
  • > Grade-2 cartilage injury
  • Having previously undergone surgery on the same knee
  • \< 18 years age
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
25 participants (estimated)

Study arms

  • Experimental
    All-inside Quadriceps Tendon Graft Group

    Procedure: Anterior Cruciate Ligament Reconstruction with Quadriceps Autograft

  • Experimental
    All-inside Hamstring Tendon Graft Group

    Procedure: Anterior Cruciate Ligament Reconstruction with Hamstring Autograft

Interventions

  • ProcedureAnterior Cruciate Ligament Reconstruction with Quadriceps Autograft

    The investigators will perform all-inside anterior cruciate ligament reconstruction using only the tendon portion of the quadriceps tendon (without bone fragments) in this group.

  • ProcedureAnterior Cruciate Ligament Reconstruction with Hamstring Autograft

    The investigators will perform all-inside anterior cruciate ligament reconstruction using the hamstring tendon as a graft in this group.

06

What researchers measure

Primary outcomes

  1. Autograft Maturation

    Comparison of different autografts maturation on MRI images. The signal-to-noise quotient formula will be used to assess graft maturation. According to the method described by Chan and Yau, the difference between the signals of the ACL graft and the quadriceps tendon will be used to evaluate maturation by relating it to the background signal.

    Time frame: 12 months

  2. Stability of Knee

    Pivot shift test

    Time frame: 9 months

  3. Stability of Knee

    laxity measuring with KT-1000 device

    Time frame: 9 months

  4. Stability of Knee

    Lachman test

    Time frame: 9 months

Secondary outcomes

  1. Range of Motion

    Measurement of knee flexion and extension degrees with a goniometer.

    Time frame: 6 months

  2. Muscle Strength

    Measurement of quadriceps and hamstring muscle strength with Cybex test

    Time frame: 9 months

07

Study locations

1 of 1 sites recruiting
  • Acibadem Fulya Hospital
    Istanbul, 34394, Turkey
    Recruiting
08

References and documents

Publications

  • Mouarbes D, Menetrey J, Marot V, Courtot L, Berard E, Cavaignac E. Anterior Cruciate Ligament Reconstruction: A Systematic Review and Meta-analysis of Outcomes for Quadriceps Tendon Autograft Versus Bone-Patellar Tendon-Bone and Hamstring-Tendon Autografts. Am J Sports Med. 2019 Dec;47(14):3531-3540. doi: 10.1177/0363546518825340. Epub 2019 Feb 21. PubMed 30790526 ↗
  • Lin KM, Boyle C, Marom N, Marx RG. Graft Selection in Anterior Cruciate Ligament Reconstruction. Sports Med Arthrosc Rev. 2020 Jun;28(2):41-48. doi: 10.1097/JSA.0000000000000265. PubMed 32345925 ↗
  • Cavaignac E, Coulin B, Tscholl P, Nik Mohd Fatmy N, Duthon V, Menetrey J. Is Quadriceps Tendon Autograft a Better Choice Than Hamstring Autograft for Anterior Cruciate Ligament Reconstruction? A Comparative Study With a Mean Follow-up of 3.6 Years. Am J Sports Med. 2017 May;45(6):1326-1332. doi: 10.1177/0363546516688665. Epub 2017 Mar 8. PubMed 28273424 ↗

Individual participant data

Plan to share: No — The investigators do not plan to share de-identified individual participant data (IPD).

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 27, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06617559
Lead sponsor
Muzaffer Agir
Collaborators
Acibadem University
Responsible party
Muzaffer Agir (Medical Doctor, Acibadem University) — Sponsor-investigator
First posted
Sep 27, 2024
Start date
May 14, 2024
Primary completion
Oct 2025 (estimated)
Completion
Mar 2026 (estimated)
Last update
Sep 27, 2024

Study contacts

Muzaffer Agir, MD
Contact
muzafferagir@gmail.com
+905543060011

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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