Ignite Creation Date:
2024-05-06 @ 8:07 PM
Last Modification Date:
2024-10-26 @ 3:21 PM
Study NCT ID:
NCT06269965
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-02-29
First Post:
2024-02-13
Brief Title:
Assessment of Collagen Membrane Interest in Distal Cuff Lesions Repair
Sponsor:
GCS Ramsay Santé pour lEnseignement et la Recherche
Organization:
GCS Ramsay Santé pour lEnseignement et la Recherche
Study Overview
Official Title:
Assessment of Collagen Membrane Interest in Distal Cuff Lesions Repair
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-02
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:
REGENECUFF
Brief Summary:
Rotator cuff refers to a set of 4 shoulder tendons These tendons are the sub-scapularis supra-spinatus infra-spinatus and teres minor Rotator cuff tear corresponds to total or partial tendon disinsertion at the greater tuberosity level or a few centimeters in upstream
Rotator cuff surgery is an increasingly popular procedure practiced in France In limited cuff lesions distal or intermediates and in absence of contraindication absence of tendons healing is around 10 to 20 Sofcot estimates that 90 of caps heals remain healed 10 years after surgery in distal lesions However even in case of a healed cuff if tendon quality is not good function will be impaired
Bioinductive implant Regeneten is an advanced healing solution for biological improvement and regeneration of tendons on all types rotator cuff tear A randomized study was initiated whose main objective was to evaluate integrity of repaired tendon with MRI one year after intervention according to Sugayas classification Results showed a recurrence rate of 83 in Regeneten group compared to 258 in witness group
In this context this study is based on hypothesis that adding Regeneten during rotator cuff repair could be beneficial on tendon healing rate but also on tendon quality healing
Rotator cuff surgery is an increasingly popular procedure practiced in France In limited cuff lesions distal or intermediates and in absence of contraindication absence of tendons healing is around 10 to 20 Sofcot estimates that 90 of caps heals remain healed 10 years after surgery in distal lesions However even in case of a healed cuff if tendon quality is not good function will be impaired
Bioinductive implant Regeneten is an advanced healing solution for biological improvement and regeneration of tendons on all types rotator cuff tear A randomized study was initiated whose main objective was to evaluate integrity of repaired tendon with MRI one year after intervention according to Sugayas classification Results showed a recurrence rate of 83 in Regeneten group compared to 258 in witness group
In this context this study is based on hypothesis that adding Regeneten during rotator cuff repair could be beneficial on tendon healing rate but also on tendon quality healing
Detailed Description:
Rotator cuff refers to a set of 4 shoulder tendons These tendons are the sub-scapularis supra-spinatus infra-spinatus and teres minor They are located at the head of arm bone humerus and cover it hence the name cap
Shoulder tendon injuries occur following sports trauma microtraumas often falling within the framework of musculoskeletal disorders MSD and heavy professional practices or they are more simply due to body natural aging
Rotator cuff tear corresponds to total or partial tendon disinsertion at the greater tuberosity level part of humerus where the supraspinatus and infraspinatus tendons insert or a few centimeters in upstream This disinsertion creates a passage between glenohumeral joint and subacromial space Subsequently rupture can extend forwards or backwards which is the most common frequent case
Rotator cuff surgery is an increasingly popular procedure practiced in France Regardless of technical progress allowing today an ambulatory arthroscopic surgery its success comes also from better knowledge of its indications and its clinical and histological results
Overall in limited cuff lesions distal or intermediates and in absence of contraindication absence of tendons healing is around 10 to 20 Sofcot estimates that 90 of caps heals remain healed 10 years after surgery in distal lesions However even in case of a healed cuff if tendon quality is not good function will be impaired Bioinductive implant Regeneten is an advanced healing solution for biological improvement and regeneration of tendons on all types rotator cuff tear A randomized study NCT04444076 was initiated whose main objective was to evaluate integrity of repaired tendon with MRI one year after intervention according to Sugayas classification Results showed at one year follow-up a recurrence rate of 83 in Regeneten group compared to 258 in witness group
In this context this study is based on hypothesis that adding Regeneten during rotator cuff repair could be beneficial on tendon healing rate but also on tendon quality healing
Shoulder tendon injuries occur following sports trauma microtraumas often falling within the framework of musculoskeletal disorders MSD and heavy professional practices or they are more simply due to body natural aging
Rotator cuff tear corresponds to total or partial tendon disinsertion at the greater tuberosity level part of humerus where the supraspinatus and infraspinatus tendons insert or a few centimeters in upstream This disinsertion creates a passage between glenohumeral joint and subacromial space Subsequently rupture can extend forwards or backwards which is the most common frequent case
Rotator cuff surgery is an increasingly popular procedure practiced in France Regardless of technical progress allowing today an ambulatory arthroscopic surgery its success comes also from better knowledge of its indications and its clinical and histological results
Overall in limited cuff lesions distal or intermediates and in absence of contraindication absence of tendons healing is around 10 to 20 Sofcot estimates that 90 of caps heals remain healed 10 years after surgery in distal lesions However even in case of a healed cuff if tendon quality is not good function will be impaired Bioinductive implant Regeneten is an advanced healing solution for biological improvement and regeneration of tendons on all types rotator cuff tear A randomized study NCT04444076 was initiated whose main objective was to evaluate integrity of repaired tendon with MRI one year after intervention according to Sugayas classification Results showed at one year follow-up a recurrence rate of 83 in Regeneten group compared to 258 in witness group
In this context this study is based on hypothesis that adding Regeneten during rotator cuff repair could be beneficial on tendon healing rate but also on tendon quality healing
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