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

Not Applicable

Completed

• Conditions: Anterior Cruciate Ligament Injuries
• Interventions: Procedure: anterior cruciate ligament recontruction

• Registration Number: NCT04940169
• Lead Sponsor: SB Istanbul Education and Research Hospital

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.

Study Timeline

• Study Start: 2018-07-06
• Primary Completion: 2021-01-30
• Study Completion: 2021-03-30
• Status Verified: 2021-06
• Study First Submitted: 2021-06-11
• Study First Submitted QC: 2021-06-17
• Last Update Submitted: 2021-06-17
• Study First Posted: 2021-06-25
• Last Update Posted: 2021-06-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 38

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
hamstring tendon autograft	anterior cruciate ligament recontruction	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.
quadriceps tendon autograft	anterior cruciate ligament recontruction	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.

Primary Outcome Measures

Name	Time	Method
lysholm	Change from Baseline score at one year.	Simple patient reported questionnaire
VAS	Change from baseline score at one year.	Simple patient reported questionnaire
KOOS	Change from Baseline score at one year.	Simple patient reported questionnaire
IKDC	Change from baseline score at one year.	Simple patient reported questionnaire
STRENGTH TEST	Change from baseline score at one year.	Simple patient reported questionnaire
subjective instability test	Change from baseline score at one year.	instability measure with help of examinations
thigh circumference	Change from baseline score at one year.	circumference measure
one leg hop test	Change from baseline score at one year.	ask to participant hop on operated leg

Trial Locations

Locations (1)

Istanbul education and research hospital; 🇹🇷 Istanbul, Turkey