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

NCT ID: NCT06617559

Last Updated: 2024-09-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-05-14

Study Completion Date

2026-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Anterior Cruciate Ligament Injuries Athletic Injuries Tendon Graft; Complications

Keywords

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anterior cruciate ligament reconstruction hamstring tendons athletic injuries

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

There are two standard autografts used for ACL reconstruction in the investigators\' clinic: quadriceps and hamstring autografts. Patients will be randomly assigned to groups based on the order of their hospital admission. It is planned to have at least 25 patients in each group.
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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All-inside Quadriceps Tendon Graft Group

Group Type EXPERIMENTAL

Anterior Cruciate Ligament Reconstruction with Quadriceps Autograft

Intervention Type PROCEDURE

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.

All-inside Hamstring Tendon Graft Group

Group Type EXPERIMENTAL

Anterior Cruciate Ligament Reconstruction with Hamstring Autograft

Intervention Type PROCEDURE

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

Interventions

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Anterior 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.

Intervention Type PROCEDURE

Anterior 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.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Elite athletes
* Amateur athletes
* Anterior cruciate ligament injury

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Acibadem University

OTHER

Sponsor Role collaborator

Muzaffer Agir

OTHER

Sponsor Role lead

Responsible Party

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Muzaffer Agir

Medical Doctor

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Acibadem Fulya Hospital

Istanbul, , Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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Muzaffer Agir, MD

Role: CONTACT

Phone: +905543060011

Email: [email protected]

Facility Contacts

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Muzaffer Agir

Role: primary

References

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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.

Reference Type BACKGROUND
PMID: 30790526 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32345925 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28273424 (View on PubMed)

Other Identifiers

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Fulyamaslak

Identifier Type: -

Identifier Source: org_study_id