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.

Study Overview

• Status: Completed
• Conditions: Knee Injuries; ACL Injury
• Intervention / Treatment: Procedure: Graft type at ACLR

• Study Type: Observational
• Enrollment (Actual): 30000

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• 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.

Description

Inclusion Criteria:

-

Exclusion Criteria:

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

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
BQT; Patients treated with the Bone Quadriceps Tendon (BQT) autograft	Procedure: Graft type at ACLR; The choice of graft at primary ACL Reconstruction
STG; Patients treated with the Semitendinosus-Gracilis (STG) autograft	Procedure: Graft type at ACLR; The choice of graft at primary ACL Reconstruction
BPTB; Patients treated with the Bone-Patellar Tendon-Bone (BPTB) autograft	Procedure: Graft type at ACLR; The choice of graft at primary ACL Reconstruction

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
Change in Tegner activity score from preoperative baseline to one-year follow-up	BQT compared to STG and BPTB, respectively	1 year
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
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
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
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
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
Absolute results of Tegner activity score at one-year follow-up	BQT compared to STG and BPTB, respectively	1 year

Collaborators and Investigators

• Sponsor: Region Zealand

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2005
• Primary Completion (ACTUAL): December 31, 2018
• Study Completion (ACTUAL): December 31, 2018

Study Registration Dates

• First Submitted: May 12, 2021
• First Submitted That Met QC Criteria: May 20, 2021
• First Posted (ACTUAL): May 25, 2021

Study Record Updates

• Last Update Posted (ACTUAL): May 25, 2021
• Last Update Submitted That Met QC Criteria: May 20, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Leg Injuries; Wounds and Injuries; Anterior Cruciate Ligament Injuries; Knee Injuries
• Other Study ID Numbers: BQT-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No