Ignite Creation Date:
2024-05-06 @ 7:54 PM
Last Modification Date:
2024-10-26 @ 3:16 PM
Study NCT ID:
NCT06178484
Status:
RECRUITING
Last Update Posted:
2023-12-29
First Post:
2023-12-11
Brief Title:
Comparison of Surgical Repair Versus Functional Treatment in Patients With Proximal ACL Tear
Sponsor:
GCS Ramsay Santé pour lEnseignement et la Recherche
Organization:
GCS Ramsay Santé pour lEnseignement et la Recherche
Study Overview
Official Title:
Comparison of Surgical Repair Versus Functional Treatment in Patients With Proximal ACL Tear
Status:
RECRUITING
Status Verified Date:
2023-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SUTUFONC
Brief 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 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
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 patients 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
Treatment of patients with proximal lesions should be graded and should take into account patients 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None