Anterior Cruciate Ligament InjuryFIRMNCT02111759
The Effect of Knee Flexion Angle for Graft Fixation During Single-Bundle Anterior Cruciate Ligament Reconstruction
A study testing knee flexion angle 1 and knee flexion angle 2 in people with Anterior Cruciate Ligament Injury, run by University of Toronto Orthopaedic Sports Medicine at 1 site in Canada.
Trial summary
The purpose of this study is to conduct a randomized controlled trial to determine if the knee flexion angle (KFA) during anterior cruciate ligament reconstruction (ACLR) graft fixation has an effect on postoperative outcomes. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Anterior Cruciate Ligament Injury
- What is being tested?
- knee flexion angle 1 and knee flexion angle 2
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 204 participants
- Where
- 1 siteCanada
- Study dates
- May 2014to Feb 2018
- Phase
- Interventional
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Male and female patients older than 16 years old with an isolated anterior cruciate ligament injury as diagnosed by clinical examination and MRI
- No pre-existing arthritis as defined by the Kellgren-Lawrence radiographic rating system
- Patients treated with an initial period of rehabilitation to eliminate swelling, optimize quadriceps strength and restore range of motion
- surgical management with a transtibial or anteromedial portal single-bundle ACLR with bone patella tendon bone (BPTB) autograft by a fellowship-trained sports medicine surgeon.
Who cannot join
- Acute ACL injuries that have not undergone an initial period of physical therapy in order to restore the aforementioned parameters
- Associated grade III injury to the MCL (medial opening >10mm at 30 degrees of knee flexion or any medial opening in extension)
- Presence of a PCL or posterolateral corner injury
- Lack of informed consent.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Knee Flexion Angle for Graft Fixation During Single-Bundle Anterior Cruciate Ligament Reconstruction - A Multicentre, Patient and Assessor Blinded, Stratified, Two-arm Parallel Group Superiority Trial
The purpose of this study is to conduct a randomized controlled trial to determine if the knee flexion angle (KFA) during anterior cruciate ligament reconstruction (ACLR) graft fixation has an effect on postoperative outcomes. The specific research questions are: what is the effect of the KFA on 1) patient-reported outcomes; 2) postoperative extension loss; 3) antero-posterior (AP) knee stability; 4) rate of re-operation.
- Conditions
- Anterior Cruciate Ligament Injury
- Being tested
- knee flexion angle 1, knee flexion angle 2
- Medical subject headings
- Anterior Cruciate Ligament Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
knee flexion angle 1Procedure or surgery
0 degrees of knee flexion during ACL graft fixation
knee flexion angle 2Procedure or surgery
30 degrees of knee flexion during ACL graft fixation
| Study group | Role | What they receive |
|---|---|---|
| knee flexion angle 2 | Other | 30 degrees of knee flexion during ACL graft fixation Receives: Procedure: knee flexion angle 2 |
| knee flexion angle 1 | Other | 0 degrees of knee flexion during ACL graft fixation Receives: Procedure: knee flexion angle 1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Knee Injury and Osteoarthritis Outcome Score (KOOS)
Measured: 24 months postoperatively
Secondary outcomes (4)
KOOS scores
Measured: 3, 6, and 12 months
Marx Activity Score (MAS)
Measured: 3, 6, 12, 24 months
the degree of extension loss in the affected knee (vs. contralateral knee)
the degree of extension in the affected knee as measured by a goniometer
Measured: 3, 6, 12, and 24 months
Side to side differences in anterior-posterior (AP) stability
differences in anterior-posterior knee (in the affected knee vs. the contralateral knee) as measured by the KT1000 arthrometer
Measured: 3, 6, 12, and 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2014 (estimated)
- Study startMay 2014
- Primary completionFeb 2018 (estimated)
- Study completionFeb 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anterior Cruciate Ligament 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 204 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Toronto Orthopaedic Sports Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Arthroscopy Association of North America
- Responsible party
- Principal investigator, Jaskarndip Chahal, University of Toronto Orthopaedic Sports Medicine
- Investigators
- Jaskarndip Chahal, MD, Principal investigator, University of Toronto Orthopaedic Sports Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02111759
- Sponsor's protocol ID
- UTOSM0001
- Acronym
- FIRM
- Status last verified
- Nov 2016
- First submitted
- 27 Mar 2014
- Last updated
- 10 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Knee Flexion Angle for Graft Fixation During Single-Bundle Anterior Cruciate Ligament Reconstruction - A Multicentre, Patient and Assessor Blinded, Stratified, Two-arm Parallel Group Superiority Trial
- ClinicalTrials.gov ID
- NCT02111759
- Acronym / sponsor ID
- FIRM / UTOSM0001
- Conditions
- Anterior Cruciate Ligament Injury
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 204 participants (actual)
- Lead sponsor
- University of Toronto Orthopaedic Sports MedicineUniversity, hospital or other
- Collaborators
- Arthroscopy Association of North America
- Study start
- May 2014
- Primary completion
- Feb 2018 (estimated)
- Study completion
- Feb 2018 (estimated)
- First posted
- 11 Apr 2014 (estimated)
- 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 this study is to conduct a randomized controlled trial to determine if the knee flexion angle (KFA) during anterior cruciate ligament reconstruction (ACLR) graft fixation has an effect on postoperative outcomes. The specific research questions are: what is the effect of the KFA on 1) patient-reported outcomes; 2) postoperative extension loss; 3) antero-posterior (AP) knee stability; 4) rate of re-operation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| knee flexion angle 2 | Other | Procedure: knee flexion angle 230 degrees of knee flexion during ACL graft fixation |
| knee flexion angle 1 | Other | Procedure: knee flexion angle 10 degrees of knee flexion during ACL graft fixation |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Male and female patients older than 16 years old with an isolated anterior cruciate ligament injury as diagnosed by clinical examination and MRI
- No pre-existing arthritis as defined by the Kellgren-Lawrence radiographic rating system
- Patients treated with an initial period of rehabilitation to eliminate swelling, optimize quadriceps strength and restore range of motion
- surgical management with a transtibial or anteromedial portal single-bundle ACLR with bone patella tendon bone (BPTB) autograft by a fellowship-trained sports medicine surgeon.
Key exclusion criteria (4 listed)
- Acute ACL injuries that have not undergone an initial period of physical therapy in order to restore the aforementioned parameters
- Associated grade III injury to the MCL (medial opening >10mm at 30 degrees of knee flexion or any medial opening in extension)
- Presence of a PCL or posterolateral corner injury
- Lack of informed consent.
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 |
|---|---|---|
| knee flexion angle 10 degrees of knee flexion during ACL graft fixation | Procedure or surgery | knee flexion angle 1 |
| knee flexion angle 230 degrees of knee flexion during ACL graft fixation | Procedure or surgery | knee flexion angle 2 |
Primary outcome
Knee Injury and Osteoarthritis Outcome Score (KOOS)
Time frame: 24 months postoperatively
4 secondary outcomes
KOOS scores
Time frame: 3, 6, and 12 months
Marx Activity Score (MAS)
Time frame: 3, 6, 12, 24 months
the degree of extension loss in the affected knee (vs. contralateral knee)
Time frame: 3, 6, 12, and 24 months
Side to side differences in anterior-posterior (AP) stability
Time frame: 3, 6, 12, and 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2016.
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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.
Jaskarndip Chahal, MD principal investigator
University of Toronto Orthopaedic Sports Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing knee flexion angle 1 and knee flexion angle 2 in people with Anterior Cruciate Ligament Injury, run by University of Toronto Orthopaedic Sports Medicine at 1 site in Canada.
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 4 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 10 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
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?
Knee Injury and Osteoarthritis Outcome Score (KOOS) (time frame: 24 months postoperatively). 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 10 Nov 2016.