NCT04940169

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
38

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 6, 2018

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2021

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 11, 2021

Completed
14 days until next milestone

First Posted

Study publicly available on registry

June 25, 2021

Completed
Last Updated

June 25, 2021

Status Verified

June 1, 2021

Enrollment Period

2.6 years

First QC Date

June 11, 2021

Last Update Submit

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

EXPERIMENTAL

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.

Procedure: anterior cruciate ligament recontruction

hamstring tendon autograft

EXPERIMENTAL

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.

Procedure: anterior cruciate ligament recontruction

Interventions

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

hamstring tendon autograftquadriceps tendon autograft

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

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)

Location

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries

Condition Hierarchy (Ancestors)

Knee InjuriesLeg InjuriesWounds and Injuries

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

Locations