Anterior Cruciate Ligament Reconstruction Made With Hamstring Tendon And Quadriceps Tendon Autografts
Prospective Comparison Of Arthroscopic Anterior Cruciate Ligament Reconstrictions Made With Hamstring Tendon And Quadriceps Tendon Autografts
1 other identifier
interventional
38
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jul 2018
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 6, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 30, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
March 30, 2021
CompletedFirst Submitted
Initial submission to the registry
June 11, 2021
CompletedFirst Posted
Study publicly available on registry
June 25, 2021
CompletedJune 25, 2021
June 1, 2021
2.6 years
June 11, 2021
June 17, 2021
Conditions
Outcome Measures
Primary Outcomes (8)
KOOS
Simple patient reported questionnaire
Change from Baseline score at one year.
lysholm
Simple patient reported questionnaire
Change from Baseline score at one year.
VAS
Simple patient reported questionnaire
Change from baseline score at one year.
IKDC
Simple patient reported questionnaire
Change from baseline score at one year.
STRENGTH TEST
Simple patient reported questionnaire
Change from baseline score at one year.
subjective instability test
instability measure with help of examinations
Change from baseline score at one year.
thigh circumference
circumference measure
Change from baseline score at one year.
one leg hop test
ask to participant hop on operated leg
Change from baseline score at one year.
Study Arms (2)
quadriceps tendon autograft
EXPERIMENTALRamdomized half of the patient underwent quadriceps graft harvesting. Arthroscopic technique fixation methods rehabilitation style follow periods kept same as hamstring group except graft type.
hamstring tendon autograft
EXPERIMENTALRamdomized half of the patient underwent hamstring graft harvesting. Arthroscopic technique fixation methods rehabilitation style follow periods kept same as hamstring group except graft type.
Interventions
Firstly graft is harvested with help of arthroscopy femoral and tibial tunnels created then graft placed into tunnels
Eligibility Criteria
You may qualify if:
- diagnosed primary ACL rupture willing to involve study
- lesser than Outerbridge 2 cartilage lesions, non-buckethandle meniscus injuries
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Istanbul education and research hospital
Istanbul, 34098, Turkey (Türkiye)
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- attendant
Study Record Dates
First Submitted
June 11, 2021
First Posted
June 25, 2021
Study Start
July 6, 2018
Primary Completion
January 30, 2021
Study Completion
March 30, 2021
Last Updated
June 25, 2021
Record last verified: 2021-06
Data Sharing
- IPD Sharing
- Will not share