Comparison of Surgical Repair Versus Functional Treatment in Patients With Proximal ACL Tear
NCT ID: NCT06178484
Last Updated: 2023-12-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
144 participants
OBSERVATIONAL
2023-12-01
2025-12-31
Brief Summary
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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
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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.
Conditions
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Study Design
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COHORT
CROSS_SECTIONAL
Study Groups
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Functional treatment
Functional treatment combines the use of splints, rehabilitation and muscle strengthening
No interventions assigned to this group
Surgical treatment
Surgical treatment means ACL tear repair
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* 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)
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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GCS Ramsay Santé pour l'Enseignement et la Recherche
OTHER
Responsible Party
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Locations
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Hôpital Privé La Louvière
Lille, Choisir Une Région, France
Countries
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Central Contacts
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Facility Contacts
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Romain LETARTRE, MD
Role: primary
Other Identifiers
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RGDS-2022-12-063
Identifier Type: -
Identifier Source: org_study_id