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

Study of the Functional Result of the Reinsertion of the Subscapular in Reverse Shoulder

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.

Study Overview

• Status: Recruiting
• Conditions: Reverse Shoulder Prothesis; Healing of the Subscapularis
• Intervention / Treatment: Procedure: Ultrasound

• Study Type: Interventional
• Enrollment (Anticipated): 170
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Normandy
    • Caen, Normandy, France, 14050
      • Recruiting
      • Saint Martin Private Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Patient with effective tendon healing	Procedure: Ultrasound; 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.
Active Comparator: Patient without tendon healing	Procedure: Ultrasound; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Ramsay Générale de Santé
• Collaborators: European Clinical Trial Experts Network

Study record dates

Study Major Dates

• Study Start (Actual): March 9, 2021
• Primary Completion (Anticipated): March 9, 2023
• Study Completion (Anticipated): March 9, 2025

Study Registration Dates

• First Submitted: October 28, 2021
• First Submitted That Met QC Criteria: October 28, 2021
• First Posted (Actual): November 1, 2021

Study Record Updates

• Last Update Posted (Actual): November 1, 2021
• Last Update Submitted That Met QC Criteria: October 28, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: 2019-A01483-54

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No