Anterior Cruciate Ligament Reconstruction Made With Hamstring Tendon And Quadriceps Tendon Autografts

NCT ID: NCT04940169

Last Updated: 2021-06-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 38 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-07-06
• Study Completion Date: 2021-03-30

Brief Summary

Anterior cruciate ligament reconstruction (ACLR) is one of the most common procedure all around the world, however optimal graft source for ACLR still remains controversial. Although Quadriceps tendon (QT) is the least used and least studied autograft, it could be an appropriate and good alternative for ACLR. If investigaters use the same surgical technique, and exert the same rehabilitation methods they may have better results than hamstring tendon (HT) autografts.

Detailed Description

Investigators enrolled 36 patient and randomized them to different group (HT, QT). at the first evaluation examination findings noted, PROMs (patient reported outcome measurements) questioned, thigh circumference measured, flexor and extensor thigh muscle strength recorded with help of Humac CYBEX Norm (CSMI, 2004) device. After these examinations and preparations all patients operated by the same surgeon who is familiar with both technique. The same surgical technique and fixation method used for both groups. At 1st year follow-up all evaluations PROMs (İKDC,lysholm,VAS) and measurements repeated. Back to the sports rates and postoperative complications compared between HT-QT.

Conditions

Anterior Cruciate Ligament Injuries

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

quadriceps tendon autograft

Ramdomized half of the patient underwent quadriceps graft harvesting. Arthroscopic technique fixation methods rehabilitation style follow periods kept same as hamstring group except graft type.

Group Type: EXPERIMENTAL

anterior cruciate ligament recontruction

Intervention Type: PROCEDURE

Firstly graft is harvested with help of arthroscopy femoral and tibial tunnels created then graft placed into tunnels

hamstring tendon autograft

Ramdomized half of the patient underwent hamstring graft harvesting. Arthroscopic technique fixation methods rehabilitation style follow periods kept same as hamstring group except graft type.

Group Type: EXPERIMENTAL

anterior cruciate ligament recontruction

Intervention Type: PROCEDURE

Firstly graft is harvested with help of arthroscopy femoral and tibial tunnels created then graft placed into tunnels

Interventions

anterior cruciate ligament recontruction

Firstly graft is harvested with help of arthroscopy femoral and tibial tunnels created then graft placed into tunnels

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

diagnosed primary ACL rupture willing to involve study

• lesser than Outerbridge 2 cartilage lesions, non-buckethandle meniscus injuries

Exclusion Criteria

more than one ligament injury greater than outerbridge 3 cartilage injury buckethandle meniscus injuries re-ruptures bilateral injuries previous knee surgery any disease affecting muscle strength

-

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

SB Istanbul Education and Research Hospital

OTHER

Sponsor Role: lead

Responsible Party

Neset Tang

attendant

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Istanbul education and research hospital

Istanbul, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

IER Hospital

Identifier Type: -

Identifier Source: org_study_id