NCT05725603

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2023

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 2, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

February 13, 2023

Completed
7 months until next milestone

Study Start

First participant enrolled

September 12, 2023

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

January 18, 2024

Status Verified

January 1, 2024

Enrollment Period

1.3 years

First QC Date

February 2, 2023

Last Update Submit

January 17, 2024

Conditions

Shoulder Injuries

Outcome Measures

Primary Outcomes (1)

  • Tendon scarring

    Tendon scarring is based on the Sugaya classification from an MRI

    1 day

Secondary Outcomes (1)

  • Fatty infiltration

    1 day

Study Arms (1)

Shoulder MRI

EXPERIMENTAL

Shoulder MRI will be performed at least 3 years after shoulder surgery

Other: MRI imaging

Interventions

MRI imagingOTHER

Shoulder MRI will be performed at least 3 years after shoulder surgery

Shoulder MRI

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Patient with a contraindication to MRI

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital Privé Jean Mermoz

Lyon, 69008, France

RECRUITING

MeSH Terms

Conditions

Shoulder Injuries

Condition Hierarchy (Ancestors)

Wounds and Injuries

Central Study Contacts

Laurent NOVE JOSSERAND, MD

CONTACT

+ 33 4 37 53 00 24lnovejosserand.md@orthosanty.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 2, 2023

First Posted

February 13, 2023

Study Start

September 12, 2023

Primary Completion

December 31, 2024

Study Completion

December 31, 2024

Last Updated

January 18, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)