NCT04901559

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2005

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2005

Completed
14 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2018

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

May 12, 2021

Completed
13 days until next milestone

First Posted

Study publicly available on registry

May 25, 2021

Completed
Last Updated

May 25, 2021

Status Verified

May 1, 2021

Enrollment Period

14 years

First QC Date

May 12, 2021

Last Update Submit

May 20, 2021

Conditions

ACL InjuryKnee Injuries

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (12)

  • Change in Knee Injury and Osteoarthritis Outcome Score subscale Pain 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

  • 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

  • +7 more secondary outcomes

Study Arms (3)

BQT

Patients treated with the Bone Quadriceps Tendon (BQT) autograft

Procedure: Graft type at ACLR

STG

Patients treated with the Semitendinosus-Gracilis (STG) autograft

Procedure: Graft type at ACLR

BPTB

Patients treated with the Bone-Patellar Tendon-Bone (BPTB) autograft

Procedure: Graft type at ACLR

Interventions

Graft type at ACLRPROCEDURE

The choice of graft at primary ACL Reconstruction

BPTBBQTSTG

Eligibility Criteria

Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Anterior Cruciate Ligament InjuriesKnee Injuries

Condition Hierarchy (Ancestors)

Leg InjuriesWounds and Injuries

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Year
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical student

Study Record Dates

First Submitted

May 12, 2021

First Posted

May 25, 2021

Study Start

January 1, 2005

Primary Completion

December 31, 2018

Study Completion

December 31, 2018

Last Updated

May 25, 2021

Record last verified: 2021-05

Data Sharing

IPD Sharing
Will not share