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

NCT05101525 | Unknown

• 1 other identifier: 2019-A01483-54
• Study Type: interventional
• Target: 170
• Locations: 1 country
• Sites: 1

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.

Conditions

Reverse Shoulder Prothesis; Healing of the Subscapularis

Outcome Measures

Primary Outcomes (2)

• Mobility of internal rotation evaluation

  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)

  12 months

• Tendon healing assessment

  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

  12 months

Study Arms (2)

Patient with effective tendon healing

EXPERIMENTAL

Procedure: Ultrasound

Patient without tendon healing

ACTIVE COMPARATOR

Procedure: Ultrasound

Interventions

Ultrasound PROCEDURE

Ultrasound 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.

Patient with effective tendon healing; Patient without tendon healing

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ramsay Générale de Santé: lead
• European Clinical Trial Experts Network: collaborator

Study Sites (1)

Saint Martin Private Hospital

Caen, Normandy, 14050, France

RECRUITING

MeSH Terms

Interventions

High-Energy Shock Waves

Intervention Hierarchy (Ancestors)

Ultrasonic Waves; Sound; Radiation, Nonionizing; Radiation; Physical Phenomena

Central Study Contacts

Jean-François Oudet

CONTACT

0683346567; jf.oudet@ecten.eu

Marie-Hélène Barba

CONTACT

mh.barba@ecten.eu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 28, 2021
• First Posted: November 1, 2021
• Study Start: March 9, 2021
• Primary Completion: March 9, 2023
• Study Completion: March 9, 2025
• Last Updated: November 1, 2021

Record last verified: 2021-10

Locations

FR (1)