Anterior Cruciate Ligament InjuriesARAVETNCT06147427
ALL Reconstruction Versus Modified Lemaire's LET in Combination With ACL Reconstruction With a Minimum Follow up of 2 Years
A study testing ACL reconstruction with hamstrings combined with ALL plasty and ACL reconstruction with hamstrings combined with modified Lemaire's LET in people with Anterior Cruciate Ligament Injuries, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
Anterior cruciate ligament (ACL) tears are associated with concomitant lesions of the anterolateral ligament (ALL), which increase rotatory instability of the knee. If untreated, ALL insufficiency can compromise the results of ACL reconstruction, with higher risk of iterative ACL tear or additional meniscal lesion. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Anterior Cruciate Ligament Injuries
- What is being tested?
- ACL reconstruction with hamstrings combined with ALL plasty and ACL reconstruction with hamstrings combined with modified Lemaire's LET
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 248 participants
- Where
- 1 siteFrance
- Study dates
- 16 Jan 2024to 16 Jan 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Man or woman with age between 18 and 50 years old
- disabling anterior chronic laxity
- 1 criteria of anterolateral plasty indication : pivot sport, rotatory instability with positive pivot shift test
- Patient who signed the informed consent form.
Who cannot join
- any associated procedure (excluding meniscal resection or repair) like osteotomy or meniscus graft
- pregnant patient
- Persons deprived of their liberty by judicial or administrative decision, persons under psychiatric care
- Adults under legal protection
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Service de chirurgie orthopédique et de médecine du sport
Lyon, 69004
Elvire SERVIEN, MD, 4 26 10 92 98 ext. +33, elvire.servien@chu-lyon.fr
About this study
Official title: ARAVET : Antero-lateral Ligament Reconstruction Versus Modified Lemaire's Lateral Extra-articular Tenodesis in Combination With ACL Reconstruction With a Minimum Follow up of 2 Years: a Randomized Controlled Trial
Anterior cruciate ligament (ACL) tears are associated with concomitant lesions of the anterolateral ligament (ALL), which increase rotatory instability of the knee. If untreated, ALL insufficiency can compromise the results of ACL reconstruction, with higher risk of iterative ACL tear or additional meniscal lesion.
Several surgical techniques have been described to reconstruct the ALL. Indications are increasingly frequent and actually, consensus being young patients, patients practising pivot sports, significant rotational laxity on clinical examination with a positive pivot shift test, or in cases of iterative surgery. To date, the two most popular techniques are the Lemaire technique (use of a fascia lata strip) and LAL reconstruction plasty (use of part of an accessory hamstring tendon).
Read more
The older Lemaire procedure, popularized in the 1980s has proved its efficiency in terms of biomechanics, safety and reproducibility. More recently, following a new, precise anatomical description, anterolateral ligament plasty (ALL) has been developed, which is intended to be more anatomical than Lemaire's technique, but whose clinical superiority has not yet been demonstrated.
Both techniques are currently used in our department, with the choice of technique left to the surgeon's discretion.
To date, no randomized prospective study has demonstrated the clinical superiority of one technique over the other with a long term follow up.
The aim of this study was to compare graft survival of ALL reconstruction versus modified Lemaire LET in combination with ACL reconstruction with a minimum follow up of 2 years. Secondary aim was to compare functional outcomes between both groups.
- Conditions
- Anterior Cruciate Ligament Injuries
- Being tested
- ACL reconstruction with hamstrings combined with ALL plasty, ACL reconstruction with hamstrings combined with modified Lemaire's LET
- Keywords
- ACL reconstruction, lateral extra-articular tenodesis, modified Lemaire tenodesis, anterolateral ligament
- 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.
ACL reconstruction with hamstrings combined with ALL plastyProcedure or surgery
ACL reconstruction with hamstrings combined anterolateral plasty using the ALL reconstruction technique (Gracilis throught the femur tunnel of the ACL graft and fixed to the tibia by an anchor on its point of isometry on the tibia).
ACL reconstruction with hamstrings combined with modified Lemaire's LETProcedure or surgery
ACL reconstruction with hamstrings combined with modified Lemaire's lateral extra-articular tenodesis technique (Fascia lata strip pedicled to the Gerdy and fixed to the femur throught the tunnel of the ACL graft).
| Study group | Role | What they receive |
|---|---|---|
| ACL reconstruction with hamstrings combined with ALL plasty | Experimental | Patient treated by ACL reconstruction with hamstrings combined anterolateral plasty using the ALL reconstruction technique (Gracilis throught the femur tunnel of the ACL graft and fixed to the tibia by an anchor on its point of isometry on the tibia). Receives: Procedure: ACL reconstruction with hamstrings combined with ALL plasty |
| ACL reconstruction with hamstrings combined with modified Lemaire's LET | Experimental | Patient treated by ACL reconstruction with hamstrings combined with modified Lemaire's lateral extra-articular tenodesis technique (Fascia lata strip pedicled to the Gerdy and fixed to the femur throught the tunnel of the ACL graft). Receives: Procedure: ACL reconstruction with hamstrings combined with modified Lemaire's LET |
What is being measured
The primary outcome is the main question the study is designed to answer.
Graft rupture rate
Graft rupture rate (percentage)
Measured: At 24 months post-operative
Secondary outcomes (2)
International Knee Documentation Committee (IKDC) score
Functional outcome : mean IKDC score
Measured: Pre-operatively and at 6, 12 and 24 months post-operatively
Complications
Complications all causes
Measured: Pre-operatively and at Day 0, Day 21, Day 45, 6 months, 12 months and 24 months post-operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2023
- Study start16 Jan 2024
- Primary completion16 Jan 2029 (estimated)
- Study completion16 Jan 2029 (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 InjuriesStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe 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
- 248 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Elvire SERVIEN, MD, Principal investigator, Service de chirurgie orthopédique et de médecine du sport
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06147427
- Sponsor's protocol ID
- 69HCL23_0851
- Other IDs
- id-rcb
- Acronym
- ARAVET
- Status last verified
- Jan 2024
- First submitted
- 17 Nov 2023
- Last updated
- 18 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- 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 18 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ARAVET : Antero-lateral Ligament Reconstruction Versus Modified Lemaire's Lateral Extra-articular Tenodesis in Combination With ACL Reconstruction With a Minimum Follow up of 2 Years: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06147427
- Acronym / sponsor ID
- ARAVET / 69HCL23_0851
- Conditions
- Anterior Cruciate Ligament Injuries
- Keywords
- ACL reconstruction, lateral extra-articular tenodesis, modified Lemaire tenodesis, anterolateral ligament
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 248 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 16 Jan 2024 (actual)
- Primary completion
- 16 Jan 2029 (estimated)
- Study completion
- 16 Jan 2029 (estimated)
- First posted
- 27 Nov 2023 (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.
Anterior cruciate ligament (ACL) tears are associated with concomitant lesions of the anterolateral ligament (ALL), which increase rotatory instability of the knee. If untreated, ALL insufficiency can compromise the results of ACL reconstruction, with higher risk of iterative ACL tear or additional meniscal lesion.
Several surgical techniques have been described to reconstruct the ALL. Indications are increasingly frequent and actually, consensus being young patients, patients practising pivot sports, significant rotational laxity on clinical examination with a positive pivot shift test, or in cases of iterative surgery. To date, the two most popular techniques are the Lemaire technique (use of a fascia lata strip) and LAL reconstruction plasty (use of part of an accessory hamstring tendon).
The older Lemaire procedure, popularized in the 1980s has proved its efficiency in terms of biomechanics, safety and reproducibility. More recently, following a new, precise anatomical description, anterolateral ligament plasty (ALL) has been developed, which is intended to be more anatomical than Lemaire's technique, but whose clinical superiority has not yet been demonstrated.
Both techniques are currently used in our department, with the choice of technique left to the surgeon's discretion.
To date, no randomized prospective study has demonstrated the clinical superiority of one technique over the other with a long term follow up.
The aim of this study was to compare graft survival of ALL reconstruction versus modified Lemaire LET in combination with ACL reconstruction with a minimum follow up of 2 years. Secondary aim was to compare functional outcomes between both groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ACL reconstruction with hamstrings combined with ALL plasty | Experimental | Procedure: ACL reconstruction with hamstrings combined with ALL plastyPatient treated by ACL reconstruction with hamstrings combined anterolateral plasty using the ALL reconstruction technique (Gracilis throught the femur tunnel of the ACL graft and fixed to the tibia by an anchor on its point of isometry on the tibia). |
| ACL reconstruction with hamstrings combined with modified Lemaire's LET | Experimental | Procedure: ACL reconstruction with hamstrings combined with modified Lemaire's LETPatient treated by ACL reconstruction with hamstrings combined with modified Lemaire's lateral extra-articular tenodesis technique (Fascia lata strip pedicled to the Gerdy and fixed to the femur throught the tunnel of the ACL graft). |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Man or woman with age between 18 and 50 years old
- disabling anterior chronic laxity
- 1 criteria of anterolateral plasty indication : pivot sport, rotatory instability with positive pivot shift test
- Patient who signed the informed consent form.
Key exclusion criteria (4 listed)
- any associated procedure (excluding meniscal resection or repair) like osteotomy or meniscus graft
- pregnant patient
- Persons deprived of their liberty by judicial or administrative decision, persons under psychiatric care
- Adults under legal protection
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 with hamstrings combined with ALL plastyACL reconstruction with hamstrings combined anterolateral plasty using the ALL reconstruction technique (Gracilis throught the femur tunnel of the ACL graft and fixed to the tibia by an anchor on its point of isometry on the tibia). | Procedure or surgery | ACL reconstruction with hamstrings combined with ALL plasty |
| ACL reconstruction with hamstrings combined with modified Lemaire's LETACL reconstruction with hamstrings combined with modified Lemaire's lateral extra-articular tenodesis technique (Fascia lata strip pedicled to the Gerdy and fixed to the femur throught the tunnel of the ACL graft). | Procedure or surgery | ACL reconstruction with hamstrings combined with modified Lemaire's LET |
Primary outcome
Graft rupture rate
Time frame: At 24 months post-operative
Graft rupture rate (percentage)
2 secondary outcomes
International Knee Documentation Committee (IKDC) score
Time frame: Pre-operatively and at 6, 12 and 24 months post-operatively
Complications
Time frame: Pre-operatively and at Day 0, Day 21, Day 45, 6 months, 12 months and 24 months post-operatively
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2024.
- 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.
Elvire SERVIEN, MD principal investigator
Service de chirurgie orthopédique et de médecine du sport
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 with hamstrings combined with ALL plasty and ACL reconstruction with hamstrings combined with modified Lemaire's LET in people with Anterior Cruciate Ligament Injuries, run by Hospices Civils de Lyon 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 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: looking for participants now, as of the sponsor's last update on 18 Jan 2024. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Elvire SERVIEN, MD (4 26 10 92 98 ext. +33, elvire.servien@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Graft rupture rate (time frame: At 24 months post-operative). 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 18 Jan 2024.