Study of the Functional Result of the Reinsertion of the Subscapular in Reverse Shoulder Prostheses According to the Healing of the Subscapular

Not Applicable

Recruiting

• Conditions: Reverse Shoulder Prothesis; Healing of the Subscapularis
• Interventions: Procedure: Ultrasound

• Registration Number: NCT05101525
• Lead Sponsor: Ramsay Générale de Santé

Brief Summary

This study is based on the hypothesis that the functional result is better if the subscapularis is reinserted and healed. The originality of the study therefore consists in systematically monitoring the healing of this tendon postoperatively, with sufficient follow-up, by ultrasound and by an intra-tendon marker, in order to differentiate the result depending on whether the tendon is healed or not.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-03-09
• Status Verified: 2021-10
• Study First Submitted: 2021-10-28
• Study First Submitted QC: 2021-10-28
• Last Update Submitted: 2021-10-28
• Study First Posted: 2021-11-01
• Last Update Posted: 2021-11-01
• Primary Completion: 2023-03-09
• Study Completion: 2025-03-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 170

Inclusion Criteria

• Men or women over 18 years old
• Patient with an indication of reverse prosthesis for cuff rupture, or eccentric omarthrosis, or omarthrosis without cuff rupture but with posterior eccentricity
• Patient with a normal subscapularis preoperatively
• Patient benefiting from a social protection insurance
• Patient having signed the free and informed consent

Exclusion Criteria

• Patient with an indication of anatomical prosthesis
• Patient with an abnormal subscapularis preoperatively
• Patient operated for a revision of prosthesis
• Patient with an indication for prosthesis on fracture sequelae
• Patient with an indication for prosthesis on fracture
• Patient participating in another clinical study
• Protected patient: adult under guardianship, curatorship or other legal protection, deprived of liberty by judicial or administrative decision
• Pregnant, breastfeeding or parturient woman
• Patient hospitalized without consent.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Patient with effective tendon healing	Ultrasound	-
Patient without tendon healing	Ultrasound	-

Primary Outcome Measures

Name	Time	Method
Mobility of internal rotation evaluation	12 months	The mobility of internal rotation will be assessed with the level of medial rotation of the Constant score (0 to 100 points - 5 different themes - 11 items)
Tendon healing assessment	12 months	The healing will be evaluated by an ultrasound allowing to visualize the intra tendinous marker. If this is in place, healing is effective. On the other hand, if it has migrated, there is no scarring

Trial Locations

Locations (1)

Saint Martin Private Hospital; 🇫🇷 Caen, Normandy, France