Back to results

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

Primary Purpose

Anterior Cruciate Ligament Injuries

Status

Completed

Phase

Not Applicable

Locations

Turkey

Study Type

Interventional

Intervention

anterior cruciate ligament recontruction

About this trial

This is an interventional treatment trial for Anterior Cruciate Ligament Injuries

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Istanbul education and research hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

quadriceps tendon autograft

hamstring tendon autograft

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

KOOS

Simple patient reported questionnaire

lysholm

Simple patient reported questionnaire

VAS

Simple patient reported questionnaire

IKDC

Simple patient reported questionnaire

STRENGTH TEST

Simple patient reported questionnaire

subjective instability test

instability measure with help of examinations

thigh circumference

circumference measure

one leg hop test

ask to participant hop on operated leg

Secondary Outcome Measures

Full Information

NCT ID

NCT04940169

First Posted

June 11, 2021

Last Updated

June 17, 2021

Sponsor

SB Istanbul Education and Research Hospital

1. Study Identification

Unique Protocol Identification Number

NCT04940169

Brief Title

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

Official Title

Prospective Comparison Of Arthroscopic Anterior Cruciate Ligament Reconstrictions Made With Hamstring Tendon And Quadriceps Tendon Autografts

Study Type

Interventional

2. Study Status

Record Verification Date

June 2021

Overall Recruitment Status

Completed

Study Start Date

July 6, 2018 (Actual)

Primary Completion Date

January 30, 2021 (Actual)

Study Completion Date

March 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

SB Istanbul Education and Research Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Anterior Cruciate Ligament Injuries

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

38 (Actual)

8. Arms, Groups, and Interventions

Arm Title

quadriceps tendon autograft

Arm Type

Experimental

Arm Description

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.

Arm Title

hamstring tendon autograft

Arm Type

Experimental

Arm Description

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.

Intervention Type

Procedure

Intervention Name(s)

anterior cruciate ligament recontruction

Intervention Description

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

Primary Outcome Measure Information:

Title

KOOS

Description

Simple patient reported questionnaire

Time Frame

Change from Baseline score at one year.

Title

lysholm

Description

Simple patient reported questionnaire

Time Frame

Change from Baseline score at one year.

Title

VAS

Description

Simple patient reported questionnaire

Time Frame

Change from baseline score at one year.

Title

IKDC

Description

Simple patient reported questionnaire

Time Frame

Change from baseline score at one year.

Title

STRENGTH TEST

Description

Simple patient reported questionnaire

Time Frame

Change from baseline score at one year.

Title

subjective instability test

Description

instability measure with help of examinations

Time Frame

Change from baseline score at one year.

Title

thigh circumference

Description

circumference measure

Time Frame

Change from baseline score at one year.

Title

one leg hop test

Description

ask to participant hop on operated leg

Time Frame

Change from baseline score at one year.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

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 -

Facility Information:

Facility Name

Istanbul education and research hospital

City

Istanbul

ZIP/Postal Code

34098

Country

Turkey

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

We'll reach out to this number within 24 hrs