Anterior Cruciate Ligament InjuryLCA IRMNCT01377129
Anterior Cruciate Ligament Reconstruction: Residual Rotational Laxity for Single Versus Double Bundle Techniques
A study testing Single bundle anterior cruciate ligament reconstruction and Double bundle anterior cruciate ligament reconstruction in people with Anterior Cruciate Ligament Injury, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.
Trial summary
The main objective of this study is to compare, using MRI measures with a specialized splint, the persistent rotatory laxity after anterior cruciate ligament reconstruction using single bundle and double bundle surgical techniques, between the seventh and eighth months after surgery, and for different degrees of knee… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anterior Cruciate Ligament Injury
- What is being tested?
- Single bundle anterior cruciate ligament reconstruction and Double bundle anterior cruciate ligament reconstruction
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteFrance
- Study dates
- Oct 2011to Sep 2014
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The patient must have given his/her informed and signed consent
- The patient must be insured or beneficiary of a health insurance plan
- The patient is available for 24 months of follow-up
- The patient requires reconstruction of the anterior cruciate ligament due to rupture confirmed by MRI
Who cannot join
- The patient is in an exclusion period determined by a previous study
- The patient is under judicial protection, under tutorship or curatorship
- The patient refuses to sign the consent
- It is impossible to correctly inform the patient
- The patient is pregnant
- The patient is breastfeeding
- The patient require a single bundle, "KJ-type" surgical technique
- Contra-indication for MRI scans
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Reconstruction of the Anterior Cruciate Ligament: a Comparative MRI Study Evaluating Residual Rotational Laxity for Single Versus Double Bundle Surgical Techniques
The main objective of this study is to compare, using MRI measures with a specialized splint, the persistent rotatory laxity after anterior cruciate ligament reconstruction using single bundle and double bundle surgical techniques, between the seventh and eighth months after surgery, and for different degrees of knee flexion (0 °, 20 °, 40 °, 60 °).
- Conditions
- Anterior Cruciate Ligament Injury
- Being tested
- Single bundle anterior cruciate ligament reconstruction, Double bundle anterior cruciate ligament reconstruction
- Keywords
- Residual Rotational Laxity
- 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.
Single bundle anterior cruciate ligament reconstructionProcedure or surgery
Single bundle anterior cruciate ligamentoplasty
Double bundle anterior cruciate ligament reconstructionProcedure or surgery
Double bundle anterior cruciate ligamentoplasty
| Study group | Role | What they receive |
|---|---|---|
| Single Bundle | Active comparator | These patients are operated using a single bundle technique. Receives: Procedure: Single bundle anterior cruciate ligament reconstruction |
| Double bundle | Experimental | These patients are operated using a double bundle technique. Receives: Procedure: Double bundle anterior cruciate ligament reconstruction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Residual rotational laxity during MRI
Residual rotational laxity is defined as the difference between the operated knee and the non-operated knee for "D", where D is the distance between the posterior tibial cortex and the center of the circle which forms the lateral femoral condyle. D will be evaluated at 4 angles of flexion (0°, 20°, 40° and 60°) and evaluated as a repeated measure.
Measured: 7-8 months post-op
Secondary outcomes (2)
Lysholm score
Measured: 7-8 months
International Knee Documentation Committee score
Measured: 7-8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2011 (estimated)
- Study startOct 2011
- Primary completionSep 2014
- Study completionSep 2014
Why it stopped: Patient enrolment proved to be more difficult than foreseen and was stopped at 46 inclusions.
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.
- More trials run by Centre Hospitalier Universitaire de NīmesThe sponsor's other registered studies.
- 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
- None (open label)
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Philippe Marchand, MD, Principal investigator, Centre Hospitalier Universitaire de Nīmes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01377129
- Sponsor's protocol ID
- LOCAL/2011/PM-03
- Other IDs
- 2011-A00465-36
- Acronym
- LCA IRM
- Status last verified
- Mar 2015
- First submitted
- 17 Jun 2011
- Last updated
- 25 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reconstruction of the Anterior Cruciate Ligament: a Comparative MRI Study Evaluating Residual Rotational Laxity for Single Versus Double Bundle Surgical Techniques
- ClinicalTrials.gov ID
- NCT01377129
- Acronym / sponsor ID
- LCA IRM / LOCAL/2011/PM-03
- Conditions
- Anterior Cruciate Ligament Injury
- Keywords
- Residual Rotational Laxity
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Patient enrolment proved to be more difficult than foreseen and was stopped at 46 inclusions.
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Study start
- Oct 2011
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 21 Jun 2011 (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 main objective of this study is to compare, using MRI measures with a specialized splint, the persistent rotatory laxity after anterior cruciate ligament reconstruction using single bundle and double bundle surgical techniques, between the seventh and eighth months after surgery, and for different degrees of knee flexion (0 °, 20 °, 40 °, 60 °).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Single Bundle | Active comparator | Procedure: Single bundle anterior cruciate ligament reconstructionThese patients are operated using a single bundle technique. |
| Double bundle | Experimental | Procedure: Double bundle anterior cruciate ligament reconstructionThese patients are operated using a double bundle technique. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- The patient must have given his/her informed and signed consent
- The patient must be insured or beneficiary of a health insurance plan
- The patient is available for 24 months of follow-up
- The patient requires reconstruction of the anterior cruciate ligament due to rupture confirmed by MRI
Key exclusion criteria (8 listed)
- The patient is in an exclusion period determined by a previous study
- The patient is under judicial protection, under tutorship or curatorship
- The patient refuses to sign the consent
- It is impossible to correctly inform the patient
- The patient is pregnant
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 |
|---|---|---|
| Single bundle anterior cruciate ligament reconstructionSingle bundle anterior cruciate ligamentoplasty | Procedure or surgery | Single Bundle |
| Double bundle anterior cruciate ligament reconstructionDouble bundle anterior cruciate ligamentoplasty | Procedure or surgery | Double bundle |
Primary outcome
Residual rotational laxity during MRI
Time frame: 7-8 months post-op
Residual rotational laxity is defined as the difference between the operated knee and the non-operated knee for "D", where D is the distance between the posterior tibial cortex and the center of the circle which forms the lateral femoral condyle. D will be evaluated at 4 angles of flexion (0°, 20°, 40° and 60°) and evaluated as a repeated measure.
2 secondary outcomes
Lysholm score
Time frame: 7-8 months
International Knee Documentation Committee score
Time frame: 7-8 months
Results and safety
The study was stopped early (reason given: Patient enrolment proved to be more difficult than foreseen and was stopped at 46 inclusions.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2015.
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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.
Philippe Marchand, MD principal investigator
Centre Hospitalier Universitaire de Nīmes
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Single bundle anterior cruciate ligament reconstruction and Double bundle anterior cruciate ligament reconstruction in people with Anterior Cruciate Ligament Injury, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.
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 8 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: stopped early, as of the sponsor's last update on 25 Mar 2015. 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 France. 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?
The study was stopped early (reason given: Patient enrolment proved to be more difficult than foreseen and was stopped at 46 inclusions.). 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?
Residual rotational laxity during MRI (time frame: 7-8 months post-op). 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 Mar 2015.