ACL - Anterior Cruciate Ligament DeficiencySUTUFONCNCT06178484
Comparison of Surgical Repair Versus Functional Treatment in Patients With Proximal ACL Tear
An observational study of ACL - Anterior Cruciate Ligament Deficiency, run by GCS Ramsay Santé pour l'Enseignement et la Recherche at 1 site in France.
Trial summary
Isolated ruptures of the anterior cruciate ligament (ACL) can be proximal, distal or occur in the middle of the ACL. Treatment of patients with proximal lesions should be graded. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ACL - Anterior Cruciate Ligament Deficiency
- How many people
- 144 participants
- Where
- 1 siteFrance
- Study dates
- 1 Dec 2023to 31 Dec 2026
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with ACL tear treated with functional or surgery treatment
Who may be able to join
- Patient, male or female, aged ≥ 18 years
- Patient with no history of knee surgery except meniscal surgery
- Patient whose period is less than 3 months between the date of the accident and the surgery
- Patient with an isolated proximal Sherman 1 or 2 ACL tear
- Patient with a proximal Sherman 1 or 2 ACL tear associated to a stable meniscal lesion or to an MCL or LCL lesion grade 1 or 2 but not grade 3
- Patient practicing a non-contact pivot sport (sliding sports, board sports,racket)
Who cannot join
- Patient with contralateral ACL tear
- Patient practicing a pivot sport with contacts
- Patient presenting external rotary jumps ++ and +++
- Patient with an ACL tear Sherman 3 or 4
- Patient with meniscal lesions in the shape of a bucket handle or tabs unstable meniscals
- Patient with a surgical history on the knee concerned
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
Hôpital Privé La Louvière
Lille, Choisir Une Région, 59800
Romain LETARTRE, MD, +33320557000, romainletartre@yahoo.fr
About this study
Isolated ruptures of the anterior cruciate ligament (ACL) can be proximal, distal or occur in the middle of the ACL.
Treatment of patients with proximal lesions should be graded. Functional treatment can be reserved for low-demanding patients in whom the practice level is limited and the risk of progression to a knee functionally unstable less marked. In athletes, the risk of a new sprain must be explained and the patient will choose a functional treatment or a surgical treatment.
Few studies exist in the literature on the superiority of surgical treatment compared to functional treatment. In this context, this study is based on the hypothesis that patients undergoing ACL surgical repair have better functional scores and more intense sport activity than patients with functional treatment.
Read the detailed description
Isolated ruptures of the anterior cruciate ligament (ACL) are ligament injuries which lead to the most surgical interventions on the capsuloligamentous system of the knee. These ruptures can be proximal, distal or occur in the middle of the ACL.
Treatment of patients with proximal lesions should be graded and should take into account patient's symptoms (feeling of instability), physical examination data, amount of residual ligament, sport practice, practice level, time interval since the initial trauma, work requirements… Functional treatment can be reserved for low-demanding patients in whom the practice level is limited and the risk of progression to a knee functionally unstable (positive pivot shift) less marked. In athletes, the risk of a new sprain must be explained and the patient will choose a functional treatment or a surgical treatment.
Functional treatment is variable, combining the use of splints, rehabilitation, muscle strengthening. The healing time is three months. Wearing a splint has not proven its effectiveness in preventing progression to rupture complete when resuming sporting activities. If instability is revealed, it is then necessary move towards ACL reconstruction treatment.
Surgical treatment generally involves ligamentoplasty at the expense of a knee tendon to replace the ruptured ACL. In the context of ACL proximal tear, the patient may be offered surgical repair of the ACL.
There are many studies on the results of ACL ligamentoplasties but literature is poor on the outcomes of modern ACL repairs. Surgical repair of the proximal rupture of ACL has experienced renewed interest in recent years thanks to the appearance of new fixing systems. Used in the 70s and 80s, this technique was gradually little abandoned in the mid-1980s following disappointing results in favor autograft reconstruction techniques.
Few studies exist in the literature on the superiority of surgical treatment compared to functional treatment. In this context, this study is based on the hypothesis that patients undergoing ACL surgical repair have better functional scores and more intense sport activity than patients with functional treatment.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Functional treatment | Functional treatment combines the use of splints, rehabilitation and muscle strengthening | |
| Surgical treatment | Surgical treatment means ACL tear repair |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subjective IKDC (International Knee Documentation Committee) score
Subjective IKDC score is based on 10 questions linded to knee status. This score is ranging from 0 to 100. 100 means a level of sport activity and daily activity without any limit in the absence of any symptoms.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2023
- Study start1 Dec 2023
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ACL - Anterior Cruciate Ligament DeficiencyStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 144 participants (estimated)
Sponsor and investigators
- Lead sponsor
- GCS Ramsay Santé pour l'Enseignement et la Recherche
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06178484
- Sponsor's protocol ID
- RGDS-2022-12-063
- Acronym
- SUTUFONC
- Status last verified
- Aug 2026
- First submitted
- 11 Dec 2023
- Last updated
- 20 Aug 2026
- 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 20 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Surgical Repair Versus Functional Treatment in Patients With Proximal ACL Tear
- ClinicalTrials.gov ID
- NCT06178484
- Acronym / sponsor ID
- SUTUFONC / RGDS-2022-12-063
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 144 participants (estimated)
- Lead sponsor
- GCS Ramsay Santé pour l'Enseignement et la RechercheUniversity, hospital or other
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 21 Dec 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.
Isolated ruptures of the anterior cruciate ligament (ACL) can be proximal, distal or occur in the middle of the ACL.
Treatment of patients with proximal lesions should be graded. Functional treatment can be reserved for low-demanding patients in whom the practice level is limited and the risk of progression to a knee functionally unstable less marked. In athletes, the risk of a new sprain must be explained and the patient will choose a functional treatment or a surgical treatment.
Few studies exist in the literature on the superiority of surgical treatment compared to functional treatment. In this context, this study is based on the hypothesis that patients undergoing ACL surgical repair have better functional scores and more intense sport activity than patients with functional treatment.
Detailed description
Isolated ruptures of the anterior cruciate ligament (ACL) are ligament injuries which lead to the most surgical interventions on the capsuloligamentous system of the knee. These ruptures can be proximal, distal or occur in the middle of the ACL.
Treatment of patients with proximal lesions should be graded and should take into account patient's symptoms (feeling of instability), physical examination data, amount of residual ligament, sport practice, practice level, time interval since the initial trauma, work requirements… Functional treatment can be reserved for low-demanding patients in whom the practice level is limited and the risk of progression to a knee functionally unstable (positive pivot shift) less marked. In athletes, the risk of a new sprain must be explained and the patient will choose a functional treatment or a surgical treatment.
Functional treatment is variable, combining the use of splints, rehabilitation, muscle strengthening. The healing time is three months. Wearing a splint has not proven its effectiveness in preventing progression to rupture complete when resuming sporting activities. If instability is revealed, it is then necessary move towards ACL reconstruction treatment.
Surgical treatment generally involves ligamentoplasty at the expense of a knee tendon to replace the ruptured ACL. In the context of ACL proximal tear, the patient may be offered surgical repair of the ACL.
There are many studies on the results of ACL ligamentoplasties but literature is poor on the outcomes of modern ACL repairs. Surgical repair of the proximal rupture of ACL has experienced renewed interest in recent years thanks to the appearance of new fixing systems. Used in the 70s and 80s, this technique was gradually little abandoned in the mid-1980s following disappointing results in favor autograft reconstruction techniques.
Few studies exist in the literature on the superiority of surgical treatment compared to functional treatment. In this context, this study is based on the hypothesis that patients undergoing ACL surgical repair have better functional scores and more intense sport activity than patients with functional treatment.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Functional treatment | – | –Functional treatment combines the use of splints, rehabilitation and muscle strengthening |
| Surgical treatment | – | –Surgical treatment means ACL tear repair |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with ACL tear treated with functional or surgery treatment
Key inclusion criteria (6 listed)
- Patient, male or female, aged ≥ 18 years
- Patient with no history of knee surgery except meniscal surgery
- Patient whose period is less than 3 months between the date of the accident and the surgery
- Patient with an isolated proximal Sherman 1 or 2 ACL tear
- Patient with a proximal Sherman 1 or 2 ACL tear associated to a stable meniscal lesion or to an MCL or LCL lesion grade 1 or 2 but not grade 3
Key exclusion criteria (6 listed)
- Patient with contralateral ACL tear
- Patient practicing a pivot sport with contacts
- Patient presenting external rotary jumps ++ and +++
- Patient with an ACL tear Sherman 3 or 4
- Patient with meniscal lesions in the shape of a bucket handle or tabs unstable meniscals
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Subjective IKDC (International Knee Documentation Committee) score
Time frame: 1 day
Subjective IKDC score is based on 10 questions linded to knee status. This score is ranging from 0 to 100. 100 means a level of sport activity and daily activity without any limit in the absence of any symptoms.
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 20 Aug 2026.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of ACL - Anterior Cruciate Ligament Deficiency, run by GCS Ramsay Santé pour l'Enseignement et la Recherche 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 6 inclusion and 6 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 20 Aug 2026. 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 Romain LETARTRE, MD (+ 33 3 20 55 70 00, romainletartre@yahoo.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Subjective IKDC (International Knee Documentation Committee) score (time frame: 1 day). 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 20 Aug 2026.