Anterior Cruciate Ligament ReconstructionNCT03192761
The Best Method for ACL Reconstruction.
A study testing ACL reconstruction hamstrings, ACL reconstruction patella tendon and ACL reconstruction iliotibial tract in people with Anterior Cruciate Ligament Reconstruction, run by Lars Konradsen at 1 site in Denmark.
Trial summary
The investigators wish to compare 3 methods for reconstruction of the anterior cruciate ligament using 3 different grafts: bone-patella tendon-bone, hamstrings and iliotibial tract graft, as these methods influence the muscles around the knee differently. Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Anterior Cruciate Ligament Reconstruction
- What is being tested?
- ACL reconstruction hamstrings, ACL reconstruction patella tendon and ACL reconstruction iliotibial tract
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Feb 2017to Dec 2021
- 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 18 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients with an ACL rupture scheduled for ACL reconstruction after clinical investigation by an orthopedic specialist at the Section of Sports Traumatology M51.
- Age 18-40 years.
- Patients able to understand given information in relation to the study and to complete out-come questionnaires.
Who cannot join
- Patient activity (sports or work) that excludes one or more of the three methods of surgery, e.g. work predominantly performed kneeling would exclude the use of the BPTBG.
- Other ligament injuries (except non-surgically treated lesion of MCL - medial collateral ligament) to the same knee or ligament injury (except non-surgically treated lesion of MCL - medial collateral ligament) to the contralateral knee
- Conditions in either knee with pain of such intensity, that participation in the functional tests of this study are impossible.
- Auto-immune disease that involves lower limb joints or muscles.
- Local or systemic infection.
- Actual or previous systemic corticosteroid, chemotherapeutic, or immunosuppressive treatment.
- BMI>30.
Trial locations and contacts
1 site in 1 country.
Denmark1 site, 1 recruiting
- Recruiting
Bisppebjerg Hospital
Copenhagen, 3400
Michael Krogsgaard, +4520512714, Michael.Krogsgaard@regionh.dk
About this study
Official title: The Best Method for ACL Reconstruction. A Study Comparing Reconstructions of Anterior Cruciate Ligament Using Grafts Taken From Three Different Anatomical Locations at the Knee and Thigh. A Randomized Clinical Trial
The investigators wish to compare 3 methods for reconstruction of the anterior cruciate ligament using 3 different grafts: bone-patella tendon-bone, hamstrings and iliotibial tract graft, as these methods influence the muscles around the knee differently. Methods using bone-patella tendon-bone and hamstrings are performed as standard operations, and the use of the iliotibial tract graft using a new method of reconstruction.
The purpose is:
- To assess whether one of three different grafts used for reconstruction of the ACL shows superior results compared to the others in relation to mechanical stability and re-rupture rates.
- To assess whether one of three different methods for reconstruction of the ACL shows superior results compared to the others in subjective patient outcome measures.
- To assess whether one of three different methods for reconstruction of the ACL shows superior results compared to the others when considering specific symptoms and complications that can be related to donor-site morbidity.
- To assess whether one of three different methods for reconstruction of the ACL shows superior results compared to the others when considering muscular power, muscle coordination, and function.
Read the detailed description
The purpose of the study is described in the "Brief Summary" section.
Patients scheduled for ACL reconstruction at the Section of Arthroscopic Surgery and Sports Traumatology M51, Department of Orthopedics, Bispebjerg-Frederiksberg Hospital are eligible for this study Eligibility criteria are described in the "Eligibility" section.
The patients are scheduled for ACL surgery at consultation with a doctor from the Section of Arthroscopic Surgery and Sports Traumatology after usual, clinical criteria. The doctor informs the patient about the project, gives the patient the written patient information, and if the patient shows interest in the study, an appointment is scheduled with one of the surgeons involved in the project.
At this appointment the patient is informed about the project by the surgeon. The patients will be granted the reflection time they need before consenting or rejecting.
Before the day of surgery muscle power, muscle coordination and functional tests are performed, and objective tests and PROMs are completed.
Surgery is performed by one of two surgeons experienced in all three methods of surgery as described in the "Arms and Interventions" section.
After the patient is put under general anaesthesia the method of ACL reconstruction is chosen by opening a sealed envelope.
Outcome measures are recorded at 1-year and 2-year follow-up.
All three methods of reconstruction are believed to have the same risk for basic complications: infection (approx. 1%), stiffening of the knee (approx. 2%) and deep venous thrombosis (approx. 1 %)
It is assumed that a 20% difference in a patient reported outcome score (KNEES-ACL) represents a clinically relevant difference. Based on standard deviations for the outcome score, and with a 90% power, significant differences of 20 % can be shown in a sample of 20 patients. Significance level is set at 5%. The investigators aim for 30 patients in each group, considering potential drop-outs.
- Being tested
- ACL reconstruction hamstrings, ACL reconstruction patella tendon, ACL reconstruction iliotibial tract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ACL reconstruction hamstringsProcedure or surgery
HG reconstruction is performed according to the standard procedure of the department:
A double semi-Tendinosus and gracillis graft is used. Placement of the bony tunnels is anatomical, and the femoral tunnel is positioned through the antero-medial portal. Fixation proximally is by CL-endobutton and at the tibia by Intrafix sheet and screw
ACL reconstruction patella tendonProcedure or surgery
PTBG reconstruction is performed according to the standard procedure of the department:
A bone patella tendon bone graft of 1 cm width from the midportion of the tendon is used. Placement of the bony tunnels is anatomical, the femoral being positioned through the antero-medial portal. Fixation proximally and distally is by interference screws.
ACL reconstruction iliotibial tractProcedure or surgery
TIFLG reconstruction is performed as follows:
The TIFL graft is harvested using two lateral incisions. The graft is left attached to the distal iliotibial tract. Placement of the bony tunnels is anatomical, the femoral being drilled outside-in. The tibial drill tunnel is made by retrograde drilling 20 mm, leaving cortical bone at the distal end of the tunnel. Fixation distally is by CL-endobutton or interference screw and on femur by an interference screw outside-in.
| Study group | Role | What they receive |
|---|---|---|
| ACL-reconstruction hamstrings | Active comparator | ACL reconstruction hamstrings Receives: Procedure: ACL reconstruction hamstrings |
| ACL-reconstruction patella tendon | Active comparator | ACL reconstruction patella tendon Receives: Procedure: ACL reconstruction patella tendon |
| ACL-reconstruction iliotibial tract | Active comparator | ACL reconstruction iliotibial tract Receives: Procedure: ACL reconstruction iliotibial tract |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in KNEES-ACL score
patient-reported outcome measure
Measured: pre-op, 1 year, 2 years
Secondary outcomes (3)
Change in anterior-posterior stability (quantified by Rolimeter)
Measure of anterio-posterior laxity
Measured: pre-op, 1 year, 2 years
Change in graded pivot shift
Subluxation of the tibia relative to the femur
Measured: pre-op, 1 year, 2 years
Change in muscle strength and forward lunge ability
Result of muscle power and muscle coordination tests
Measured: pre-op, 1 year, 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2017
- Study start1 Feb 2017
- Primary completionDec 2019 (estimated)
- Study completionDec 2021 (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 ReconstructionStudies 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
- When the patient has been anaesthetized for surgery, the method of reconstruction is defined by opening a sealed envelope in the operating theatre.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lars Konradsen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Lars Konradsen, Bispebjerg Hospital
- Investigators
- Michael Krogsgaard, Study director, Head of section
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03192761
- Sponsor's protocol ID
- BBH-ACL-1
- Status last verified
- Jul 2019
- First submitted
- 27 Apr 2017
- Last updated
- 11 Jul 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Best Method for ACL Reconstruction. A Study Comparing Reconstructions of Anterior Cruciate Ligament Using Grafts Taken From Three Different Anatomical Locations at the Knee and Thigh. A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03192761
- Acronym / sponsor ID
- BBH-ACL-1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Lars KonradsenUniversity, hospital or other
- Study start
- 1 Feb 2017 (actual)
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 20 Jun 2017 (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 investigators wish to compare 3 methods for reconstruction of the anterior cruciate ligament using 3 different grafts: bone-patella tendon-bone, hamstrings and iliotibial tract graft, as these methods influence the muscles around the knee differently. Methods using bone-patella tendon-bone and hamstrings are performed as standard operations, and the use of the iliotibial tract graft using a new method of reconstruction.
The purpose is:
- To assess whether one of three different grafts used for reconstruction of the ACL shows superior results compared to the others in relation to mechanical stability and re-rupture rates.
- To assess whether one of three different methods for reconstruction of the ACL shows superior results compared to the others in subjective patient outcome measures.
- To assess whether one of three different methods for reconstruction of the ACL shows superior results compared to the others when considering specific symptoms and complications that can be related to donor-site morbidity.
- To assess whether one of three different methods for reconstruction of the ACL shows superior results compared to the others when considering muscular power, muscle coordination, and function.
Detailed description
The purpose of the study is described in the "Brief Summary" section.
Patients scheduled for ACL reconstruction at the Section of Arthroscopic Surgery and Sports Traumatology M51, Department of Orthopedics, Bispebjerg-Frederiksberg Hospital are eligible for this study Eligibility criteria are described in the "Eligibility" section.
The patients are scheduled for ACL surgery at consultation with a doctor from the Section of Arthroscopic Surgery and Sports Traumatology after usual, clinical criteria. The doctor informs the patient about the project, gives the patient the written patient information, and if the patient shows interest in the study, an appointment is scheduled with one of the surgeons involved in the project.
At this appointment the patient is informed about the project by the surgeon. The patients will be granted the reflection time they need before consenting or rejecting.
Before the day of surgery muscle power, muscle coordination and functional tests are performed, and objective tests and PROMs are completed.
Surgery is performed by one of two surgeons experienced in all three methods of surgery as described in the "Arms and Interventions" section.
After the patient is put under general anaesthesia the method of ACL reconstruction is chosen by opening a sealed envelope.
Outcome measures are recorded at 1-year and 2-year follow-up.
All three methods of reconstruction are believed to have the same risk for basic complications: infection (approx. 1%), stiffening of the knee (approx. 2%) and deep venous thrombosis (approx. 1 %)
It is assumed that a 20% difference in a patient reported outcome score (KNEES-ACL) represents a clinically relevant difference. Based on standard deviations for the outcome score, and with a 90% power, significant differences of 20 % can be shown in a sample of 20 patients. Significance level is set at 5%. The investigators aim for 30 patients in each group, considering potential drop-outs.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- When the patient has been anaesthetized for surgery, the method of reconstruction is defined by opening a sealed envelope in the operating theatre.
| Arm | Type | Receives |
|---|---|---|
| ACL-reconstruction hamstrings | Active comparator | Procedure: ACL reconstruction hamstringsACL reconstruction hamstrings |
| ACL-reconstruction patella tendon | Active comparator | Procedure: ACL reconstruction patella tendonACL reconstruction patella tendon |
| ACL-reconstruction iliotibial tract | Active comparator | Procedure: ACL reconstruction iliotibial tractACL reconstruction iliotibial tract |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Patients with an ACL rupture scheduled for ACL reconstruction after clinical investigation by an orthopedic specialist at the Section of Sports Traumatology M51.
- Age 18-40 years.
- Patients able to understand given information in relation to the study and to complete out-come questionnaires.
Key exclusion criteria (7 listed)
- Patient activity (sports or work) that excludes one or more of the three methods of surgery, e.g. work predominantly performed kneeling would exclude the use of the BPTBG.
- Other ligament injuries (except non-surgically treated lesion of MCL - medial collateral ligament) to the same knee or ligament injury (except non-surgically treated lesion of MCL - medial collateral ligament) to the contralateral knee
- Conditions in either knee with pain of such intensity, that participation in the functional tests of this study are impossible.
- Auto-immune disease that involves lower limb joints or muscles.
- Local or systemic infection.
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 |
|---|---|---|
| ACL reconstruction hamstringsHG reconstruction is performed according to the standard procedure of the department: A double semi-Tendinosus and gracillis graft is used. Placement of the bony tunnels is anatomical, and the femoral tunnel is positioned through the antero-medial portal. Fixation proximally is by CL-endobutton and at the tibia by Intrafix sheet and screw | Procedure or surgery | ACL-reconstruction hamstrings |
| ACL reconstruction patella tendonPTBG reconstruction is performed according to the standard procedure of the department: A bone patella tendon bone graft of 1 cm width from the midportion of the tendon is used. Placement of the bony tunnels is anatomical, the femoral being positioned through the antero-medial portal. Fixation proximally and distally is by interference screws. | Procedure or surgery | ACL-reconstruction patella tendon |
| ACL reconstruction iliotibial tractTIFLG reconstruction is performed as follows: The TIFL graft is harvested using two lateral incisions. The graft is left attached to the distal iliotibial tract. Placement of the bony tunnels is anatomical, the femoral being drilled outside-in. The tibial drill tunnel is made by retrograde drilling 20 mm, leaving cortical bone at the distal end of the tunnel. Fixation distally is by CL-endobutton or interference screw and on femur by an interference screw outside-in. | Procedure or surgery | ACL-reconstruction iliotibial tract |
Primary outcome
Change in KNEES-ACL score
Time frame: pre-op, 1 year, 2 years
patient-reported outcome measure
3 secondary outcomes
Change in anterior-posterior stability (quantified by Rolimeter)
Time frame: pre-op, 1 year, 2 years
Change in graded pivot shift
Time frame: pre-op, 1 year, 2 years
Change in muscle strength and forward lunge ability
Time frame: pre-op, 1 year, 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2019.
- Individual participant dataSharing planned: Undecided. Yes
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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.
Michael Krogsgaard study director
Head of section
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ACL reconstruction hamstrings, ACL reconstruction patella tendon and ACL reconstruction iliotibial tract in people with Anterior Cruciate Ligament Reconstruction, run by Lars Konradsen at 1 site in Denmark.
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 3 inclusion and 7 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 11 Jul 2019. 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 Denmark. 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?
Contact Lars Konradsen (+4540284517, Lars.Konradsen@Regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in KNEES-ACL score (time frame: pre-op, 1 year, 2 years). 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 11 Jul 2019.