Clinical and Anatomical Evaluation of Healing of Lesions... | NCT05725603

Studies
Clinical and Anatomical Evaluation of Healing of Lesions of the Subscapular Tendon

NCT05725603

Sponsor

GCS Ramsay Santé pour l'Enseignement et la Recherche

Status

Unknown status

Last Update Posted

Jan 18, 2024Actual

Enrollment

100Estimated

Phase

Not Applicable

Conditions

Shoulder Injuries

Interventions

MRI imaging

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2024

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 12, 2023Actual

Primary Completion Date

Dec 31, 2024Estimated

Completion Date

Dec 31, 2024Estimated

First Submitted Date

Feb 2, 2023

First Submission Date that Met QC Criteria

Feb 2, 2023

First Posted Date

Feb 13, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 17, 2024

Last Update Posted Date

Jan 18, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This study is based on the hypothesis that fatty infiltration postoperative is not or only slightly modified after an atomic repair of lesions of the subscapularis tendon according to a new arthroscopic classification.

Detailed Description

After repair of isolated lesions of the subscapularis, it is observed, in nearly half of the cases, a increased fatty infiltration of the subscapularis muscle indicating a probable persistence of the tendon rupture while the Healing failure rate is recognized as moderate (about 15%).

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Shoulder MRI	Experimental	Shoulder MRI will be performed at least 3 years after shoulder surgery	Other: MRI imaging

Interventions

Name	Type	Description	Arm Group Labels	Other Names
MRI imaging	Other	Shoulder MRI will be performed at least 3 years after shoulder surgery	Shoulder MRI

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Tendon scarring	Tendon scarring is based on the Sugaya classification from an MRI	1 day

Secondary Outcomes

Measure	Description	Time Frame
Fatty infiltration	The fatty infiltration of the subscapularis muscle is evaluated according to Goutallier's classification	1 day

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patient, male or female, aged ≥ 18 years
Patient who has undergone surgical repair for a rupture or rotator cuff injury involving the subscapularis tendon between April and September 2016 and between May 2018 and January 2019
Patient with a lesion of the subscapularis tendon characterized with arthroscopic classification
Patient who has previously participated in the classification study of subscapularis tendon injuries based on findings arthroscopy conducted only at the Jean Mermoz Hospital

Exclusion Criteria:

Patient with a contraindication to MRI

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Laurent NOVE JOSSERAND, MD	Contact	+ 33 4 37 53 00 24		lnovejosserand.md@orthosanty.fr

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hôpital Privé Jean Mermoz	Recruiting	Lyon		69008	France

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D000070599	Shoulder Injuries

Ancestor Terms

ID	Term
D014947	Wounds and Injuries

Browse Leaves

Not provided

Browse Branches

Not provided