Anterior Cruciate Ligament InjuryKFA-FIRMNCT03875807
The Effect of Knee Flexion Angle for Graft Fixation During Single-Bundle Anterior Cruciate Ligament Reconstruction
A study testing ACLR done at 0 degrees KFA and ACLR done at 30 degrees KFA in people with Anterior Cruciate Ligament Injury, run by Women's College Hospital.
Trial summary
The overall aim of this study is to determine the effect of the knee flexion angle (KFA) of either 0 degrees, or 30 degrees (measured by sterile goniometer) during anterior cruciate ligament (ACL) fixation on postoperative outcomes following single-bundle ACL reconstruction with bone patellar tendon bone (BPTB)… 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?
- ACLR done at 0 degrees KFA and ACLR done at 30 degrees KFA
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 204 participants
- Where
- No sites listed yet
- Study dates
- 16 Apr 2014to 1 Dec 2019
- 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.
- Provision of Informed Consent
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.
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 overall aim of this study is to determine the effect of the knee flexion angle (KFA) of either 0 degrees, or 30 degrees (measured by sterile goniometer) during anterior cruciate ligament (ACL) fixation on postoperative outcomes following single-bundle ACL reconstruction with bone patellar tendon bone (BPTB) autograft. The specific aims of the current study include determining the effect of the knee flexion angle on 1) patient-reported outcomes; 2) postoperative extension loss; 3) antero-posterior (AP) knee stability; 4) rate of re-operation.
Read the detailed description
At the present time, there is no consensus about the position of the knee during tensioning anterior cruciate ligament (ACL) graft fixation at the time of reconstruction, although it can be assumed to be one of the key factors for successful ACL reconstruction (ACLR). In studies that have investigated transtibial ACLR, it was suggested that 20 degrees is the ideal KFA to optimize graft force and the relative Antero-Posterior (AP) tibiofemoral relationship, while several other authors have advocated fixation in full extension to avoid overconstraining the knee. In the setting of anatomic ACLR, it has been reported that the tensioning of the graft at 30 degrees of knee flexion was associated with loss of knee extension when the anatomic femoral tunnel was chosen. Previous studies have performed gait analysis during walking in 24 patients with ACLR with hamstring autograft where graft fixation was performed at 25 degrees of knee flexion. In these study, the trans tibial (TT) technique resulted in significantly greater anterior femoral translation than healthy controls during the swing phase and excessive tibial internal rotation (IR) was found at midstance. In knees repaired with the anteromedial portal (AMP) technique, subjects were significantly less extended (5 degrees) compared with controls in late stance phase. While the AMP technique has the potential to improve overall joint stability, patients were shown to have increased difficulty with knee extension. It has also been demonstrated that since the anteromedial (AM) and posterolateral (PL) bundles of the ACL are at their longest in knee extension, the best angle for fixation would be near full extension. The aforementioned studies support the concept that anatomic ACL has an increased likelihood of anisometry and as a result the chosen KFA for fixation becomes increasingly important.
The lack of consensus regarding the optimal KFA in ACLR is reflected in the practice patterns of surgeons. A survey of Canadian Orthopaedic Surgeons demonstrated that 40% of surgeons fix the ACL at a 30 degree KFA while 30% perform fixation in full extension. The purpose of this study is to conduct a randomized controlled trial to determine if the KFA during ACLR graft fixation has an effect on postoperative outcomes. Patients undergoing single bundle BPTB ACLR will be randomized to have the surgical repair done with a KFA of either 0 degrees, or 30 degrees (measured by sterile goniometer) during anterior cruciate ligament (ACL) fixation. Patients will be followed for 24 months post surgery, with a number of qualitative patient surveys and clinical measurements being collected at 3, 6, 12 and 24 months post op, with changes being compared to baseline survey response and clinical measurement scores.
- Conditions
- Anterior Cruciate Ligament Injury
- Being tested
- ACLR done at 0 degrees KFA, ACLR done at 30 degrees KFA
- Keywords
- ACL, ACL reconstruction, Knee Flexion Angle, Bone Patellar Tendon Bone
- 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.
ACLR done at 0 degrees KFAProcedure or surgery
Patients randomized to this arm will undergo the following intervention: Anterior Cruciate Ligament Reconstruction (ACLR) done at 0 degrees knee angle flexion (KFA)
ACLR done at 30 degrees KFAProcedure or surgery
Patients randomized to this arm will undergo the following intervention: Anterior Cruciate Ligament Reconstruction (ACLR) done at 30 degrees knee angle flexion (KFA)
| Study group | Role | What they receive |
|---|---|---|
| 0 degree Knee Flexion Angle ACLR | Active comparator | At the time of surgery, tunnel position and surgical technique will be standardized for transtibial and anteromedial portal ACLR. Individuals randomized to this arm intra-operatively to undergo fixation of the ACL graft on the tibial side at a KFA of 0 degrees as measured by a sterile goniometer. Grafts will be tensioned according to the maximum surgeon-applied tension at the designated KFA. After surgery, patients will be treated with a standardized accelerated physical therapy protocol Receives: Procedure: ACLR done at 0 degrees KFA |
| 30 degree Knee Flexion Angle ACLR | Active comparator | At the time of surgery, tunnel position and surgical technique will be standardized for transtibial and anteromedial portal ACLR. Individuals randomized to this arm intra-operatively to undergo fixation of the ACL graft on the tibial side at a KFA of 30 degrees as measured by a sterile goniometer. Grafts will be tensioned according to the maximum surgeon-applied tension at the designated KFA. After surgery, patients will be treated with a standardized accelerated physical therapy protocol Receives: Procedure: ACLR done at 30 degrees KFA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Knee Injury and Osteoarthritis Outcome Score (KOOS)
The KOOS questionnaire consists of 5 subscales; Pain, other Symptoms, Function in daily living (ADL), Function in sport and recreation (Sport/Rec) and knee related Quality of life (QOL). The previous week is the time period considered when answering the questions. Standardized answer options are given (5 Likert boxes) and each question is assigned a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale.
Measured: Completed 24 months post ACL repair at 0 or 30 degrees flexion
Secondary outcomes (5)
Knee Injury and Osteoarthritis Outcome Score (KOOS)
The KOOS questionnaire consists of 5 subscales; Pain, other Symptoms, Function in daily living (ADL), Function in sport and recreation (Sport/Rec) and knee related Quality of life (QOL). The previous week is the time period considered when answering the questions. Standardized answer options are given (5 Likert boxes) and each question is assigned a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale.
Measured: Completed 3, 6 and 12 months post ACL repair at 0 or 30 degrees flexion
Marx Activity Score questionnaire
The Marx Scale is a validated survey for orthopaedics that consists of four questions concerning four activities or actions: running, cutting, deceleration, and pivoting. The patient or survey respondent is asked to report on the frequency with which they performed the activity in their healthiest state within the past year.
It is designed to be completed in less than one minute. The questionnaire is focused on actions that may be affected by disorders of the knee.
Measured: Completed at 3, 6, 12, 24 months post ACL repair at 0 or 30 degrees flexion
Loss of Extension on Operative Knee
Extension loss versus contralateral knee measured clinically in degrees with a goniometer
Measured: Extension is measured at 3, 6, 12 and 24 months post ACL repair
Side to side differences in Anterior Posterior joint stability as measured by the KT-1000 Arthrometer
The KT-1000 knee arthrometer (KT-1000) is an objective instrument to measure anterior tibial motion relative to the femur for anterior cruciate ligament (ACL) reconstruction. Measurements are captured on both the operative and non operative knee, and recorded at 0 degrees and 25 degrees flexion with a support placed under the knee for the latter measurement
Measured: KT-1000 measurements are recorded at 3, 6,12 and 24 months post ACL repair
Rate of Reoperation
Rate of reoperation is recorded from date of original surgery to 24 months post original ACL repair, reoperations captured include retear of ACL, and any meniscus related tears.
Measured: Patients are followed for 24 months post initial ACL surgery to capture any instances of reoperation on the affected knee
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2019
- Study start16 Apr 2014
- Primary completion1 Dec 2019
- Study completion1 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Model description
- A Multicentre, Pragmatic, Patient and Assessor Blinded, Stratified, Two-arm Parallel (1:1) Group Superiority Trial
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 204 participants (actual)
Sponsor and investigators
- Lead sponsor
- Women's College Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Arthroscopy Association of North America
- Responsible party
- Principal investigator, Dr. Jas Chahal, Women's College Hospital
- Investigators
- Jas Chahal, MD, MSc, MBA, Principal investigator, Women's College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03875807
- Sponsor's protocol ID
- 2014-0006-B
- Acronym
- KFA-FIRM
- Status last verified
- May 2020
- First submitted
- 13 Mar 2019
- Last updated
- 19 May 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Chahal J, Whelan DB, Hoit G, Theodoropoulos J, Ajrawat P, Betsch M, Docter S, Dwyer T. Anterior Cruciate Ligament Patellar Tendon Autograft Fixation at 0 degrees Versus 30 degrees Results in Improved Activity Scores and a Greater Proportion of Patients Achieving the Minimal Clinical Important Difference For Knee Injury and Osteoarthritis Outcome Score Pain: A Randomized Controlled Trial. Arthroscopy. 2022 Jun;38(6):1969-1977. doi: 10.1016/j.arthro.2021.12.018. Epub 2021 Dec 22.
PubMed 34952186
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2020. 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
- NCT03875807
- Acronym / sponsor ID
- KFA-FIRM / 2014-0006-B
- Conditions
- Anterior Cruciate Ligament Injury
- Keywords
- ACL, ACL reconstruction, Knee Flexion Angle, Bone Patellar Tendon Bone
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 204 participants (actual)
- Lead sponsor
- Women's College HospitalUniversity, hospital or other
- Collaborators
- Arthroscopy Association of North America
- Study start
- 16 Apr 2014 (actual)
- Primary completion
- 1 Dec 2019 (actual)
- Study completion
- 1 Dec 2019 (actual)
- First posted
- 15 Mar 2019 (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 overall aim of this study is to determine the effect of the knee flexion angle (KFA) of either 0 degrees, or 30 degrees (measured by sterile goniometer) during anterior cruciate ligament (ACL) fixation on postoperative outcomes following single-bundle ACL reconstruction with bone patellar tendon bone (BPTB) autograft. The specific aims of the current study include determining the effect of the knee flexion angle on 1) patient-reported outcomes; 2) postoperative extension loss; 3) antero-posterior (AP) knee stability; 4) rate of re-operation.
Detailed description
At the present time, there is no consensus about the position of the knee during tensioning anterior cruciate ligament (ACL) graft fixation at the time of reconstruction, although it can be assumed to be one of the key factors for successful ACL reconstruction (ACLR). In studies that have investigated transtibial ACLR, it was suggested that 20 degrees is the ideal KFA to optimize graft force and the relative Antero-Posterior (AP) tibiofemoral relationship, while several other authors have advocated fixation in full extension to avoid overconstraining the knee. In the setting of anatomic ACLR, it has been reported that the tensioning of the graft at 30 degrees of knee flexion was associated with loss of knee extension when the anatomic femoral tunnel was chosen. Previous studies have performed gait analysis during walking in 24 patients with ACLR with hamstring autograft where graft fixation was performed at 25 degrees of knee flexion. In these study, the trans tibial (TT) technique resulted in significantly greater anterior femoral translation than healthy controls during the swing phase and excessive tibial internal rotation (IR) was found at midstance. In knees repaired with the anteromedial portal (AMP) technique, subjects were significantly less extended (5 degrees) compared with controls in late stance phase. While the AMP technique has the potential to improve overall joint stability, patients were shown to have increased difficulty with knee extension. It has also been demonstrated that since the anteromedial (AM) and posterolateral (PL) bundles of the ACL are at their longest in knee extension, the best angle for fixation would be near full extension. The aforementioned studies support the concept that anatomic ACL has an increased likelihood of anisometry and as a result the chosen KFA for fixation becomes increasingly important.
The lack of consensus regarding the optimal KFA in ACLR is reflected in the practice patterns of surgeons. A survey of Canadian Orthopaedic Surgeons demonstrated that 40% of surgeons fix the ACL at a 30 degree KFA while 30% perform fixation in full extension. The purpose of this study is to conduct a randomized controlled trial to determine if the KFA during ACLR graft fixation has an effect on postoperative outcomes. Patients undergoing single bundle BPTB ACLR will be randomized to have the surgical repair done with a KFA of either 0 degrees, or 30 degrees (measured by sterile goniometer) during anterior cruciate ligament (ACL) fixation. Patients will be followed for 24 months post surgery, with a number of qualitative patient surveys and clinical measurements being collected at 3, 6, 12 and 24 months post op, with changes being compared to baseline survey response and clinical measurement scores.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- A Multicentre, Pragmatic, Patient and Assessor Blinded, Stratified, Two-arm Parallel (1:1) Group Superiority Trial
| Arm | Type | Receives |
|---|---|---|
| 0 degree Knee Flexion Angle ACLR | Active comparator | Procedure: ACLR done at 0 degrees KFAAt the time of surgery, tunnel position and surgical technique will be standardized for transtibial and anteromedial portal ACLR. Individuals randomized to this arm intra-operatively to undergo fixation of the ACL graft on the tibial side at a KFA of 0 degrees as measured by a sterile goniometer. Grafts will be tensioned according to the maximum surgeon-applied tension at the designated KFA. After surgery, patients will be treated with a standardized accelerated physical therapy protocol |
| 30 degree Knee Flexion Angle ACLR | Active comparator | Procedure: ACLR done at 30 degrees KFAAt the time of surgery, tunnel position and surgical technique will be standardized for transtibial and anteromedial portal ACLR. Individuals randomized to this arm intra-operatively to undergo fixation of the ACL graft on the tibial side at a KFA of 30 degrees as measured by a sterile goniometer. Grafts will be tensioned according to the maximum surgeon-applied tension at the designated KFA. After surgery, patients will be treated with a standardized accelerated physical therapy protocol |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 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.
- Provision of Informed Consent
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 |
|---|---|---|
| ACLR done at 0 degrees KFAPatients randomized to this arm will undergo the following intervention: Anterior Cruciate Ligament Reconstruction (ACLR) done at 0 degrees knee angle flexion (KFA) | Procedure or surgery | 0 degree Knee Flexion Angle ACLR |
| ACLR done at 30 degrees KFAPatients randomized to this arm will undergo the following intervention: Anterior Cruciate Ligament Reconstruction (ACLR) done at 30 degrees knee angle flexion (KFA) | Procedure or surgery | 30 degree Knee Flexion Angle ACLR |
Primary outcome
Knee Injury and Osteoarthritis Outcome Score (KOOS)
Time frame: Completed 24 months post ACL repair at 0 or 30 degrees flexion
The KOOS questionnaire consists of 5 subscales; Pain, other Symptoms, Function in daily living (ADL), Function in sport and recreation (Sport/Rec) and knee related Quality of life (QOL). The previous week is the time period considered when answering the questions. Standardized answer options are given (5 Likert boxes) and each question is assigned a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale.
5 secondary outcomes
Knee Injury and Osteoarthritis Outcome Score (KOOS)
Time frame: Completed 3, 6 and 12 months post ACL repair at 0 or 30 degrees flexion
Marx Activity Score questionnaire
Time frame: Completed at 3, 6, 12, 24 months post ACL repair at 0 or 30 degrees flexion
Loss of Extension on Operative Knee
Time frame: Extension is measured at 3, 6, 12 and 24 months post ACL repair
Side to side differences in Anterior Posterior joint stability as measured by the KT-1000 Arthrometer
Time frame: KT-1000 measurements are recorded at 3, 6,12 and 24 months post ACL repair
Rate of Reoperation
Time frame: Patients are followed for 24 months post initial ACL surgery to capture any instances of reoperation on the affected knee
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 19 May 2020.
- Derived from this study: PubMed 34952186Chahal J, Whelan DB, Hoit G, Theodoropoulos J, Ajrawat P, Betsch M, Docter S, Dwyer T. Anterior Cruciate Ligament Patellar Tendon Autograft Fixation at 0 degrees Versus 30 degrees Results in Improved Activity Scores and a Greater Proportion of Patients Achieving the Minimal Clinical Important Difference For Knee Injury and Osteoarthritis Outcome Score Pain: A Randomized Controlled Trial. Arthroscopy. 2022 Jun;38(6):1969-1977. doi: 10.1016/j.arthro.2021.12.018. Epub 2021 Dec 22.
- Individual participant dataSharing planned: Undecided
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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.
Jas Chahal, MD, MSc, MBA principal investigator
Women's College Hospital
Questions about this trial
What is this clinical trial studying?
A study testing ACLR done at 0 degrees KFA and ACLR done at 30 degrees KFA in people with Anterior Cruciate Ligament Injury, run by Women's College Hospital.
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 5 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: finished, as of the sponsor's last update on 19 May 2020. 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?
Knee Injury and Osteoarthritis Outcome Score (KOOS) (time frame: Completed 24 months post ACL repair at 0 or 30 degrees flexion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03875807, which also lists 1 linked publication.
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 19 May 2020.