Clinical trial NCT04901559: Subjective Outcomes After ACL Reconstruction With BQT Autograft
Official title: Subjective Outcomes After ACL Reconstruction With BQT Autograft
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: ACL Injury
Knee Injuries
Lead sponsor: Region Zealand
Sponsor class: OTHER
First posted: 2021-05-25
Enrollment: 30000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients from the nationwide Danish Knee Ligament Reconstruction Register (DKLR) recruited from both private and public clinics from January 1st 2005 through December 31st 2018.

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.


Eligibility criteria: Inclusion Criteria:

-

Exclusion Criteria:

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

Primary outcomes:
measure: Change in Knee Injury and Osteoarthritis Outcome Score from preoperative baseline to one-year follow-up
timeFrame: 1 year
Secondary outcomes:
measure: Change in Knee Injury and Osteoarthritis Outcome Score subscale Pain from preoperative baseline to one-year follow-up
timeFrame: 1 year
measure: Change in Knee Injury and Osteoarthritis Outcome Score subscale Symptoms from preoperative baseline to one-year follow-up
timeFrame: 1 year
measure: Change in Knee Injury and Osteoarthritis Outcome Score subscale Activities of Daily Living (ADL) from preoperative baseline to one-year follow-up
timeFrame: 1 year
measure: Change in Knee Injury and Osteoarthritis Outcome Score subscale Sports/Recreation from preoperative baseline to one-year follow-up
timeFrame: 1 year
measure: Change in Knee Injury and Osteoarthritis Outcome Score subscale Quality of Life (QoL) from preoperative baseline to one-year follow-up
timeFrame: 1 year
measure: Change in Tegner activity score from preoperative baseline to one-year follow-up
timeFrame: 1 year
measure: Absolute results of Knee Injury and Osteoarthritis Outcome Score subscale Pain at one-year follow-up
timeFrame: 1 year
measure: Absolute results of Knee Injury and Osteoarthritis Outcome Score subscale Symptoms at one-year follow-up
timeFrame: 1 year
measure: Absolute results of Knee Injury and Osteoarthritis Outcome Score subscale Activities of Daily Living (ADL) at one-year follow-up
timeFrame: 1 year
measure: Absolute results of Knee Injury and Osteoarthritis Outcome Score subscale Sports/Recreation at one-year follow-up
timeFrame: 1 year
measure: Absolute results of Knee Injury and Osteoarthritis Outcome Score subscale Quality of Life (QoL) at one-year follow-up
timeFrame: 1 year
measure: Absolute results of Tegner activity score at one-year follow-up
timeFrame: 1 year
Other outcomes:
Locations:
Study officials:
References: