ACL InjuryNCT04901559
Subjective Outcomes After ACL Reconstruction With BQT Autograft
An observational study of ACL Injury and Knee Injuries, run by Region Zealand.
Trial 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). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- ACL Injury, Knee Injuries
- What is being tested?
- Graft type at ACLR
- Type of treatment
- Surgery or procedure
- How many people
- 30,000 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2005to 31 Dec 2018
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Child, Adult, Older adult
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.
Who may be able to join
- -
Who cannot join
- Revision ACL Surgery
- Multiligament surgery
- Nonresponders in PROM at preoperative baseline or one-year follow-up
About this study
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.
- Conditions
- ACL Injury, Knee Injuries
- Being tested
- Graft type at ACLR
- Medical subject headings
- Anterior Cruciate Ligament Injuries, Knee Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Graft type at ACLRProcedure or surgery
The choice of graft at primary ACL Reconstruction
| Study group | Role | What they receive |
|---|---|---|
| BQT | Patients treated with the Bone Quadriceps Tendon (BQT) autograft Receives: Procedure: Graft type at ACLR | |
| STG | Patients treated with the Semitendinosus-Gracilis (STG) autograft Receives: Procedure: Graft type at ACLR | |
| BPTB | Patients treated with the Bone-Patellar Tendon-Bone (BPTB) autograft Receives: Procedure: Graft type at ACLR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Knee Injury and Osteoarthritis Outcome Score from preoperative baseline to one-year follow-up
BQT compared to STG and BPTB, respectively
Measured: 1 year
Secondary outcomes (12)
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 1 year
Change in Tegner activity score from preoperative baseline to one-year follow-up
BQT compared to STG and BPTB, respectively
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 1 year
Absolute results of Tegner activity score at one-year follow-up
BQT compared to STG and BPTB, respectively
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2021
- Study start1 Jan 2005
- Primary completion31 Dec 2018
- Study completion31 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ACL InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30,000 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Region Zealand
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jesper Glerup, Region Zealand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04901559
- Sponsor's protocol ID
- BQT-1
- Status last verified
- May 2021
- First submitted
- 12 May 2021
- Last updated
- 25 May 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Subjective Outcomes After ACL Reconstruction With BQT Autograft
- ClinicalTrials.gov ID
- NCT04901559
- Acronym / sponsor ID
- BQT-1
- Conditions
- ACL Injury, Knee Injuries
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30,000 participants (actual)
- Lead sponsor
- Region ZealandUniversity, hospital or other
- Study start
- 1 Jan 2005 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 25 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| BQT | – | Procedure: Graft type at ACLRPatients treated with the Bone Quadriceps Tendon (BQT) autograft |
| STG | – | Procedure: Graft type at ACLRPatients treated with the Semitendinosus-Gracilis (STG) autograft |
| BPTB | – | Procedure: Graft type at ACLRPatients treated with the Bone-Patellar Tendon-Bone (BPTB) autograft |
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- -
Key exclusion criteria (3 listed)
- Revision ACL Surgery
- Multiligament surgery
- Nonresponders in PROM at preoperative baseline or one-year follow-up
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Graft type at ACLRThe choice of graft at primary ACL Reconstruction | Procedure or surgery | BPTB, BQT, STG |
Primary outcome
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
12 secondary outcomes
Change in Knee Injury and Osteoarthritis Outcome Score subscale Pain from preoperative baseline to one-year follow-up
Time frame: 1 year
Change in Knee Injury and Osteoarthritis Outcome Score subscale Symptoms from preoperative baseline to one-year follow-up
Time frame: 1 year
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
Change in Knee Injury and Osteoarthritis Outcome Score subscale Sports/Recreation from preoperative baseline to one-year follow-up
Time frame: 1 year
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
Change in Tegner activity score from preoperative baseline to one-year follow-up
Time frame: 1 year
Absolute results of Knee Injury and Osteoarthritis Outcome Score subscale Pain at one-year follow-up
Time frame: 1 year
Absolute results of Knee Injury and Osteoarthritis Outcome Score subscale Symptoms at one-year follow-up
Time frame: 1 year
Absolute results of Knee Injury and Osteoarthritis Outcome Score subscale Activities of Daily Living (ADL) at one-year follow-up
Time frame: 1 year
Absolute results of Knee Injury and Osteoarthritis Outcome Score subscale Sports/Recreation at one-year follow-up
Time frame: 1 year
Absolute results of Knee Injury and Osteoarthritis Outcome Score subscale Quality of Life (QoL) at one-year follow-up
Time frame: 1 year
Absolute results of Tegner activity score at one-year follow-up
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of ACL Injury and Knee Injuries, run by Region Zealand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 May 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Knee Injury and Osteoarthritis Outcome Score from preoperative baseline to one-year follow-up (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 May 2021.