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Completed

NCT Number: NCT04901559

Subjective Outcomes After ACL Reconstruction With BQT Autograft

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.

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Key information

Conditions

ACL Injury Anterior Cruciate Ligament Injuries Knee Injuries Leg Injuries Wounds and Injuries

Sex eligibility

All sexes

Study type

Observational

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

-

Exclusion criteria

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

Treatment and study plan

Graft type at ACLR

Procedure

The choice of graft at primary ACL Reconstruction

Primary outcomes

  1. 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

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

    Time frame: 1 year

    BQT compared to STG and BPTB, respectively

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

    Time frame: 1 year

    BQT compared to STG and BPTB, respectively

  3. Change in Knee Injury and Osteoarthritis Outcome Score subscale Activities of Daily Living (ADL) from preoperative baseline to one-year follow-up

    Time frame: 1 year

    BQT compared to STG and BPTB, respectively

  4. Change in Knee Injury and Osteoarthritis Outcome Score subscale Sports/Recreation from preoperative baseline to one-year follow-up

    Time frame: 1 year

    BQT compared to STG and BPTB, respectively

  5. Change in Knee Injury and Osteoarthritis Outcome Score subscale Quality of Life (QoL) from preoperative baseline to one-year follow-up

    Time frame: 1 year

    BQT compared to STG and BPTB, respectively

  6. Change in Tegner activity score from preoperative baseline to one-year follow-up

    Time frame: 1 year

    BQT compared to STG and BPTB, respectively

  7. Absolute results of Knee Injury and Osteoarthritis Outcome Score subscale Pain at one-year follow-up

    Time frame: 1 year

    BQT compared to STG and BPTB, respectively

  8. Absolute results of Knee Injury and Osteoarthritis Outcome Score subscale Symptoms at one-year follow-up

    Time frame: 1 year

    BQT compared to STG and BPTB, respectively

  9. Absolute results of Knee Injury and Osteoarthritis Outcome Score subscale Activities of Daily Living (ADL) at one-year follow-up

    Time frame: 1 year

    BQT compared to STG and BPTB, respectively

  10. Absolute results of Knee Injury and Osteoarthritis Outcome Score subscale Sports/Recreation at one-year follow-up

    Time frame: 1 year

    BQT compared to STG and BPTB, respectively

  11. Absolute results of Knee Injury and Osteoarthritis Outcome Score subscale Quality of Life (QoL) at one-year follow-up

    Time frame: 1 year

    BQT compared to STG and BPTB, respectively

  12. Absolute results of Tegner activity score at one-year follow-up

    Time frame: 1 year

    BQT compared to STG and BPTB, respectively

Sponsors and collaborators

Lead sponsor

Region Zealand

Other

Registry information

Important dates

Study start
2005
Primary completion
2018
Study completion
2018
First posted
May 25, 2021
Registry last updated
May 25, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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