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

A Prospective Comparison of Clinical and Radiological Maturation Outcomes of Autologous Quadriceps and Hamstring Tendon Grafts in Anterior Cruciate Ligament Reconstruction

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.

Study Overview

• Status: Recruiting
• Conditions: Anterior Cruciate Ligament Injuries; Athletic Injuries; Tendon Graft; Complications
• Intervention / Treatment: Procedure: Anterior Cruciate Ligament Reconstruction with Quadriceps Autograft; Procedure: Anterior Cruciate Ligament Reconstruction with Hamstring Autograft

• Study Type: Interventional
• Enrollment (Estimated): 25
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Muzaffer Agir, MD; Phone Number: +905543060011; Email: muzafferagir@gmail.com

Study Locations

• Turkey
  • Istanbul, Turkey, 34394
    • Recruiting
    • Acibadem Fulya Hospital
    • Contact: Muzaffer Agir; Phone Number: +905543060011; Email: muzafferagir@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: All-inside Quadriceps Tendon Graft Group	Procedure: 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.
Experimental: All-inside Hamstring Tendon Graft Group	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Range of Motion	Measurement of knee flexion and extension degrees with a goniometer.	6 months
Muscle Strength	Measurement of quadriceps and hamstring muscle strength with Cybex test	9 months

Collaborators and Investigators

• Sponsor: Muzaffer Agir
• Collaborators: Acibadem University

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): May 14, 2024
• Primary Completion (Estimated): October 1, 2025
• Study Completion (Estimated): March 1, 2026

Study Registration Dates

• First Submitted: September 23, 2024
• First Submitted That Met QC Criteria: September 26, 2024
• First Posted (Actual): September 27, 2024

Study Record Updates

• Last Update Posted (Actual): September 27, 2024
• Last Update Submitted That Met QC Criteria: September 26, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Keywords: anterior cruciate ligament reconstruction; athletic injuries; hamstring tendons
• Additional Relevant MeSH Terms: Leg Injuries; Knee Injuries; Wounds and Injuries; Anterior Cruciate Ligament Injuries; Athletic Injuries
• Other Study ID Numbers: Fulyamaslak

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The investigators do not plan to share de-identified individual participant data (IPD).

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No