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NCT04901559 Clinical Trial

Subjective Outcomes After ACL Reconstruction With BQT Autograft

Knee Injuries Clinical Trial

Official title:
Subjective Outcomes After ACL Reconstruction With BQT Autograft

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04901559
Other study ID # BQT-1
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 1, 2005
Est. completion date December 31, 2018

Study information
Verified date May 2021
Source Region Zealand
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Completed
Enrollment 30000
Est. completion date December 31, 2018
Est. primary completion date December 31, 2018
Accepts healthy volunteers
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - Exclusion Criteria: - Revision ACL Surgery - Multiligament surgery - Nonresponders in PROM at preoperative baseline or one-year follow-up

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Graft type at ACLR
The choice of graft at primary ACL Reconstruction

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Region Zealand

Outcome
Type Measure Description Time frame Safety issue
Primary Change in Knee Injury and Osteoarthritis Outcome Score from preoperative baseline to one-year follow-up BQT compared to STG and BPTB, respectively 1 year
Secondary Change in Knee Injury and Osteoarthritis Outcome Score subscale Pain from preoperative baseline to one-year follow-up BQT compared to STG and BPTB, respectively 1 year
Secondary Change in Knee Injury and Osteoarthritis Outcome Score subscale Symptoms from preoperative baseline to one-year follow-up BQT compared to STG and BPTB, respectively 1 year
Secondary Change in Knee Injury and Osteoarthritis Outcome Score subscale Activities of Daily Living (ADL) from preoperative baseline to one-year follow-up BQT compared to STG and BPTB, respectively 1 year
Secondary Change in Knee Injury and Osteoarthritis Outcome Score subscale Sports/Recreation from preoperative baseline to one-year follow-up BQT compared to STG and BPTB, respectively 1 year
Secondary Change in Knee Injury and Osteoarthritis Outcome Score subscale Quality of Life (QoL) from preoperative baseline to one-year follow-up BQT compared to STG and BPTB, respectively 1 year
Secondary Change in Tegner activity score from preoperative baseline to one-year follow-up BQT compared to STG and BPTB, respectively 1 year
Secondary Absolute results of Knee Injury and Osteoarthritis Outcome Score subscale Pain at one-year follow-up BQT compared to STG and BPTB, respectively 1 year
Secondary Absolute results of Knee Injury and Osteoarthritis Outcome Score subscale Symptoms at one-year follow-up BQT compared to STG and BPTB, respectively 1 year
Secondary Absolute results of Knee Injury and Osteoarthritis Outcome Score subscale Activities of Daily Living (ADL) at one-year follow-up BQT compared to STG and BPTB, respectively 1 year
Secondary Absolute results of Knee Injury and Osteoarthritis Outcome Score subscale Sports/Recreation at one-year follow-up BQT compared to STG and BPTB, respectively 1 year
Secondary Absolute results of Knee Injury and Osteoarthritis Outcome Score subscale Quality of Life (QoL) at one-year follow-up BQT compared to STG and BPTB, respectively 1 year
Secondary Absolute results of Tegner activity score at one-year follow-up BQT compared to STG and BPTB, respectively 1 year
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