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

NCT ID: NCT05101525

Last Updated: 2021-11-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

170 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-09

Study Completion Date

2025-03-09

Brief Summary

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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

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Conditions

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Reverse Shoulder Prothesis Healing of the Subscapularis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Patient with effective tendon healing

Group Type EXPERIMENTAL

Ultrasound

Intervention Type 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 without tendon healing

Group Type ACTIVE_COMPARATOR

Ultrasound

Intervention Type 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.

Interventions

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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.

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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European Clinical Trial Experts Network

OTHER

Sponsor Role collaborator

Ramsay Générale de Santé

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Saint Martin Private Hospital

Caen, Normandy, France

Site Status RECRUITING

Countries

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France

Central Contacts

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Jean-François Oudet

Role: CONTACT

Phone: 0683346567

Email: [email protected]

Marie-Hélène Barba

Role: CONTACT

Email: [email protected]

Facility Contacts

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Jean Francois OUDET

Role: primary

Marie Barba

Role: backup

Other Identifiers

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2019-A01483-54

Identifier Type: -

Identifier Source: org_study_id