Subjective Outcomes After ACL Reconstruction With BQT Autograft

NCT ID: NCT04901559

Last Updated: 2021-05-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

30000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2005-01-01

Study Completion Date

2018-12-31

Brief Summary

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The purpose of the study is to compare short-term patient reported outcome measures (PROM) of Bone-Quadriceps-Tendon (BQT) autograft with Semitendinosus-Gracilis (STG) and Bone-Patellar-Tendon-Bone (BPTB) autografts following Anterior Cruciate Ligament Reconstruction (ACLR).

The PROM used are Knee Injury and Osteoarthrithis Outcome Score (KOOS) and Tegner. Difference in change in KOOS, KOOS subscales and Tegner from preoperative baseline to one-year follow-up and absolute KOOS, KOOS subscales and Tegner at one-year follow-up were evaluated. All of which were BQT compared to STG and BPTB, respectively. The primary outcome is change in KOOS from preoperative baselinge to one-year follow-up. Other outcomes are secondary.

The hypothesis was that patients receiving the BQT autograft show similar results in KOOS, KOOS subscales and Tegner as patients receiving STG or BPTB autografts.

Detailed Description

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Conditions

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ACL Injury Knee Injuries

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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BQT

Patients treated with the Bone Quadriceps Tendon (BQT) autograft

Graft type at ACLR

Intervention Type PROCEDURE

The choice of graft at primary ACL Reconstruction

STG

Patients treated with the Semitendinosus-Gracilis (STG) autograft

Graft type at ACLR

Intervention Type PROCEDURE

The choice of graft at primary ACL Reconstruction

BPTB

Patients treated with the Bone-Patellar Tendon-Bone (BPTB) autograft

Graft type at ACLR

Intervention Type PROCEDURE

The choice of graft at primary ACL Reconstruction

Interventions

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Graft type at ACLR

The choice of graft at primary ACL Reconstruction

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

\-

Exclusion Criteria

* Revision ACL Surgery
* Multiligament surgery
* Nonresponders in PROM at preoperative baseline or one-year follow-up
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Region Zealand

OTHER

Sponsor Role lead

Responsible Party

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Jesper Glerup

Medical student

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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BQT-1

Identifier Type: -

Identifier Source: org_study_id

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