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Clinical Trials/NCT04901559
NCT04901559
Completed
Not Applicable

Subjective Outcomes After ACL Reconstruction With BQT Autograft

Region Zealand0 sites30,000 target enrollmentJanuary 1, 2005

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
ACL Injury
Sponsor
Region Zealand
Enrollment
30000
Primary Endpoint
Change in Knee Injury and Osteoarthritis Outcome Score from preoperative baseline to one-year follow-up
Status
Completed
Last Updated
4 years ago

Overview

Brief 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.

Registry
clinicaltrials.gov
Start Date
January 1, 2005
End Date
December 31, 2018
Last Updated
4 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Region Zealand
Responsible Party
Principal Investigator
Principal Investigator

Jesper Glerup

Medical student

Region Zealand

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

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

Outcomes

Primary Outcomes

Change in Knee Injury and Osteoarthritis Outcome Score from preoperative baseline to one-year follow-up

Time Frame: 1 year

BQT compared to STG and BPTB, respectively

Secondary Outcomes

  • Change in Knee Injury and Osteoarthritis Outcome Score subscale Activities of Daily Living (ADL) from preoperative baseline to one-year follow-up(1 year)
  • Change in Knee Injury and Osteoarthritis Outcome Score subscale Sports/Recreation from preoperative baseline to one-year follow-up(1 year)
  • Change in Knee Injury and Osteoarthritis Outcome Score subscale Quality of Life (QoL) from preoperative baseline to one-year follow-up(1 year)
  • Change in Tegner activity score from preoperative baseline to one-year follow-up(1 year)
  • Change in Knee Injury and Osteoarthritis Outcome Score subscale Symptoms from preoperative baseline to one-year follow-up(1 year)
  • Absolute results of Tegner activity score at one-year follow-up(1 year)
  • Absolute results of Knee Injury and Osteoarthritis Outcome Score subscale Quality of Life (QoL) at one-year follow-up(1 year)
  • Absolute results of Knee Injury and Osteoarthritis Outcome Score subscale Pain at one-year follow-up(1 year)
  • Absolute results of Knee Injury and Osteoarthritis Outcome Score subscale Symptoms at one-year follow-up(1 year)
  • Change in Knee Injury and Osteoarthritis Outcome Score subscale Pain from preoperative baseline to one-year follow-up(1 year)
  • Absolute results of Knee Injury and Osteoarthritis Outcome Score subscale Activities of Daily Living (ADL) at one-year follow-up(1 year)
  • Absolute results of Knee Injury and Osteoarthritis Outcome Score subscale Sports/Recreation at one-year follow-up(1 year)

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