Anterior Cruciate Ligament InjuryNCT03740022
ACL Versus ALL + ACL Study
A study testing ACL plasty and ACL + ALL plasty in people with Anterior Cruciate Ligament Injury and Ligament Rupture, run by Ascopharm Groupe Novasco at 1 site in France.
Trial summary
The aim of the study is to show a reduction of a re-rupture rate with an ACL (antero crusader ligament) + ALL (anterolateral ligament) combined technique compared to a classical Kenneth-Jones ACL (antero crusader ligament) reconstruction technique. Read more about this study
- Who is it for?
- Ages 18 to 35 years
- Conditions the study is for
- Anterior Cruciate Ligament Injury, Ligament Rupture
- What is being tested?
- ACL plasty and ACL + ALL plasty
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 592 participants
- Where
- 1 siteFrance
- Study dates
- 2 Nov 2016to 10 Jun 2024
- 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 35 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients with total isolated antero crusader ligament (ACL) rupture who are candidates for surgical reconstruction
- Patients between 18 and 35 years old
- Patients with weekly sporting activities
- Patients with chronic rotatory instability with a positive pivot shift
- Patients who have been informed and do not object the research
Who cannot join
- Patients with multi-ligament knee involvement
- Patients under 18 years old or over 35 years old
- Patients with a BMI of under 18.5 or over 30
- Patients with any contraindication to general anaesthesia
- Professional sportsmen/women
- Patients with congenital malformation or a rheumatic disease
Show all 9Show fewer
- Patients with repeated antero crusader ligament (ACL) rupture
- Patients with serious ligament disease in the contralateral knee
- Patients who refuse to take part in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of the Results of Combined Anterolateral Ligament (ALL) + Antero Crusader Ligament (ACL) Plasty Compared to Classical KJ Plasty in Isolated ACL Ruptures
The aim of the study is to show a reduction of a re-rupture rate with an ACL (antero crusader ligament) + ALL (anterolateral ligament) combined technique compared to a classical Kenneth-Jones ACL (antero crusader ligament) reconstruction technique.
Read the detailed description
The aim is to evaluate the rate of re-rupture and to analyze knee function through scores analysis as International Knee Documentation Committee Subjective Knee (IKDC), Knee injury and osteoarthritis outcome score (KOOS), Lysholm-Tegner, and by objective measurements of laximetry and rotation.
This study should include 2 groups of 296 patients with isolated ACL (antero crusader ligament) with clinical rotation :
- operated by a conventional patellar tendon technique (first group)
- operated by a technique combining a ALL (anterolateral ligament) and ACL plasty for the second group
- Being tested
- ACL plasty, ACL + ALL plasty
- 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 plastyProcedure or surgery
standard ligamentoplasty by Kenneth Jones
ACL + ALL plastyProcedure or surgery
standard ligamentoplasty and anterolateral plasty
| Study group | Role | What they receive |
|---|---|---|
| ACL plasty | Active comparator | The surgical procedure consists of a ligamentoplasty of the antero crusader ligament (ACL) with the patellar tendon according to a conventional arthroscopic procedure. Receives: Procedure: ACL plasty |
| ACL + ALL plasty | Experimental | The surgical procedure consists of a hamstring ligamentoplasty (DIDT) of the antero crusader ligament (ACL) and anterolateral ligament (ALL) according to a published arthroscopic procedure. Receives: Procedure: ACL + ALL plasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ligament re-rupture rate
Clinical instability, laximetry, IRM
Measured: 3 years
Secondary outcomes (6)
International Knee Documentation Committee Subjective Knee (IKDC) clinical score
International Knee Documentation Committee Subjective Knee allows a subjective assessment including symptoms, activity and knee function; is scored by summing the scores for the individual items and then transforming the score to a scale that ranges from 0 to 100 (no limitation with activities of daily living or sports activities and the absence of symptoms)
Measured: preoperatively, 1 year and 3 years
Tegner Lysholm score
Specific knee questionnaire : patient-reported instrument that consists of subscales for pain, instability, locking, swelling, limp, stair climbing, squatting, and the need for support. Scores range from 0 (worse disability) to 100 (less disability).
Measured: Preoperatively, 1 year and 3 years
Rolimeter test
Antero-posterior laximetry
Measured: pre-operatively, 6 months, 1 year and 3 years
KiRA test
Rotatory laximetry
Measured: preoperatively, 6 months and 3 years
Knee radiography
Development of osteoarthritis signs
Measured: preoperatively and 3 years
Knee injury and osteoarthritis outcome score (KOOS) clinical score
Knee injury and osteoarthritis outcome score is a specific knee questionnaire which evaluates : pain, symptoms, knee function in daily life, knee function in sport practice and quality of life. Scale : None (0) Mild Moderate Severe Extreme (4) Each subscale score is calculated independently. Calculate the mean score of the individual items of each subscale and divide by 4. Traditionally in orthopedics, 100 indicates no problems and 0 indicates extreme problems
Measured: preoperative, 1 year and 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2018
- Study start2 Nov 2016
- Primary completion10 Jun 2024
- Study completion10 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 592 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ascopharm Groupe Novasco
- Sponsor type
- University, hospital or other
- Collaborators
- GCS Ramsay Santé pour l'Enseignement et la Recherche
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03740022
- Sponsor's protocol ID
- 2016-A00144-47
- Status last verified
- Nov 2024
- First submitted
- 29 Nov 2016
- Last updated
- 25 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
Publications
Sonnery-Cottet B, Carrozzo A, Poilvache H, Fayard JM, Freychet B, Thaunat M, Vieira TD, Saithna A; Santy Orthopedic Center Group. Anterior cruciate ligament reconstruction combined with anterolateral ligament reconstruction using hamstring autograft versus anterior cruciate ligament reconstruction using bone-patellar tendon-bone autograft: a randomised controlled trial with 5-year follow-up. Lancet Reg Health Eur. 2025 Dec 20;62:101561. doi: 10.1016/j.lanepe.2025.101561. eCollection 2026 Mar.
PubMed 41536854Sonnery-Cottet B, Pioger C, Vieira TD, Franck F, Kajetanek C, Fayard JM, Thaunat M, Saithna A. Combined ACL and Anterolateral Reconstruction Is Not Associated With a Higher Risk of Adverse Outcomes: Preliminary Results From the SANTI Randomized Controlled Trial. Orthop J Sports Med. 2020 May 1;8(5):2325967120918490. doi: 10.1177/2325967120918490. eCollection 2020 May.
PubMed 32490026
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Results of Combined Anterolateral Ligament (ALL) + Antero Crusader Ligament (ACL) Plasty Compared to Classical KJ Plasty in Isolated ACL Ruptures
- ClinicalTrials.gov ID
- NCT03740022
- Acronym / sponsor ID
- 2016-A00144-47
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 592 participants (actual)
- Lead sponsor
- Ascopharm Groupe NovascoUniversity, hospital or other
- Collaborators
- GCS Ramsay Santé pour l'Enseignement et la Recherche
- Study start
- 2 Nov 2016 (actual)
- Primary completion
- 10 Jun 2024 (actual)
- Study completion
- 10 Jun 2024 (actual)
- First posted
- 14 Nov 2018 (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 aim of the study is to show a reduction of a re-rupture rate with an ACL (antero crusader ligament) + ALL (anterolateral ligament) combined technique compared to a classical Kenneth-Jones ACL (antero crusader ligament) reconstruction technique.
Detailed description
The aim is to evaluate the rate of re-rupture and to analyze knee function through scores analysis as International Knee Documentation Committee Subjective Knee (IKDC), Knee injury and osteoarthritis outcome score (KOOS), Lysholm-Tegner, and by objective measurements of laximetry and rotation.
This study should include 2 groups of 296 patients with isolated ACL (antero crusader ligament) with clinical rotation :
- operated by a conventional patellar tendon technique (first group)
- operated by a technique combining a ALL (anterolateral ligament) and ACL plasty for the second group
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ACL plasty | Active comparator | Procedure: ACL plastyThe surgical procedure consists of a ligamentoplasty of the antero crusader ligament (ACL) with the patellar tendon according to a conventional arthroscopic procedure. |
| ACL + ALL plasty | Experimental | Procedure: ACL + ALL plastyThe surgical procedure consists of a hamstring ligamentoplasty (DIDT) of the antero crusader ligament (ACL) and anterolateral ligament (ALL) according to a published arthroscopic procedure. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Patients with total isolated antero crusader ligament (ACL) rupture who are candidates for surgical reconstruction
- Patients between 18 and 35 years old
- Patients with weekly sporting activities
- Patients with chronic rotatory instability with a positive pivot shift
- Patients who have been informed and do not object the research
Key exclusion criteria (9 listed)
- Patients with multi-ligament knee involvement
- Patients under 18 years old or over 35 years old
- Patients with a BMI of under 18.5 or over 30
- Patients with any contraindication to general anaesthesia
- Professional sportsmen/women
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 plastystandard ligamentoplasty by Kenneth Jones | Procedure or surgery | ACL plasty |
| ACL + ALL plastystandard ligamentoplasty and anterolateral plasty | Procedure or surgery | ACL + ALL plasty |
Primary outcome
Ligament re-rupture rate
Time frame: 3 years
Clinical instability, laximetry, IRM
6 secondary outcomes
International Knee Documentation Committee Subjective Knee (IKDC) clinical score
Time frame: preoperatively, 1 year and 3 years
Tegner Lysholm score
Time frame: Preoperatively, 1 year and 3 years
Rolimeter test
Time frame: pre-operatively, 6 months, 1 year and 3 years
KiRA test
Time frame: preoperatively, 6 months and 3 years
Knee radiography
Time frame: preoperatively and 3 years
Knee injury and osteoarthritis outcome score (KOOS) clinical score
Time frame: preoperative, 1 year and 3 years
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 25 Nov 2024.
- Derived from this study: PubMed 41536854Sonnery-Cottet B, Carrozzo A, Poilvache H, Fayard JM, Freychet B, Thaunat M, Vieira TD, Saithna A; Santy Orthopedic Center Group. Anterior cruciate ligament reconstruction combined with anterolateral ligament reconstruction using hamstring autograft versus anterior cruciate ligament reconstruction using bone-patellar tendon-bone autograft: a randomised controlled trial with 5-year follow-up. Lancet Reg Health Eur. 2025 Dec 20;62:101561. doi: 10.1016/j.lanepe.2025.101561. eCollection 2026 Mar.
- Derived from this study: PubMed 32490026Sonnery-Cottet B, Pioger C, Vieira TD, Franck F, Kajetanek C, Fayard JM, Thaunat M, Saithna A. Combined ACL and Anterolateral Reconstruction Is Not Associated With a Higher Risk of Adverse Outcomes: Preliminary Results From the SANTI Randomized Controlled Trial. Orthop J Sports Med. 2020 May 1;8(5):2325967120918490. doi: 10.1177/2325967120918490. eCollection 2020 May.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 plasty and ACL + ALL plasty in people with Anterior Cruciate Ligament Injury and Ligament Rupture, run by Ascopharm Groupe Novasco 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 5 inclusion and 9 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 25 Nov 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?
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?
Ligament re-rupture rate (time frame: 3 years). 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 NCT03740022, which also lists 2 linked publications.
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 Nov 2024.