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

NCT06617559 | Recruiting

• 1 other identifier: Fulyamaslak
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Keywords

anterior cruciate ligament reconstruction; hamstring tendons; athletic injuries

Outcome Measures

Primary Outcomes (4)

• 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.

  12 months

• Stability of Knee

  Pivot shift test

  9 months

• Stability of Knee

  laxity measuring with KT-1000 device

  9 months

• Stability of Knee

  Lachman test

  9 months

Secondary Outcomes (2)

• Range of Motion

  6 months

• Muscle Strength

  9 months

Study Arms (2)

All-inside Quadriceps Tendon Graft Group

EXPERIMENTAL

Procedure: Anterior Cruciate Ligament Reconstruction with Quadriceps Autograft

All-inside Hamstring Tendon Graft Group

EXPERIMENTAL

Procedure: Anterior Cruciate Ligament Reconstruction with Hamstring Autograft

Interventions

Anterior Cruciate Ligament Reconstruction with Quadriceps Autograft 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 Quadriceps Tendon Graft Group

Anterior Cruciate Ligament Reconstruction with Hamstring Autograft PROCEDURE

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

All-inside Hamstring Tendon Graft Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Elite athletes
• Amateur athletes
• Anterior cruciate ligament injury

You may not qualify if:

• 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

Sponsors & Collaborators

• Muzaffer Agir: lead
• Acibadem University: collaborator

Study Sites (1)

Acibadem Fulya Hospital

Istanbul, 34394, Turkey (Türkiye)

RECRUITING

Related Publications (3)

• 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.

  PMID: 30790526 BACKGROUND

• 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.

  PMID: 32345925 BACKGROUND

• 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.

  PMID: 28273424 BACKGROUND

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries; Athletic Injuries

Interventions

Anterior Cruciate Ligament Reconstruction

Condition Hierarchy (Ancestors)

Knee Injuries; Leg Injuries; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Arthroplasty; Orthopedic Procedures; Surgical Procedures, Operative; Plastic Surgery Procedures

Central Study Contacts

Muzaffer Agir, MD

CONTACT

+905543060011; muzafferagir@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Medical Doctor

Model Details: There are two standard autografts used for ACL reconstruction in the investigators\&#39; 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.

Study Record Dates

• First Submitted: September 23, 2024
• First Posted: September 27, 2024
• Study Start: May 14, 2024
• Primary Completion: October 1, 2025
• Study Completion: March 1, 2026
• Last Updated: September 27, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)