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

R

Ramsay Générale de Santé

Status

Enrolling

Conditions

Healing of the Subscapularis
Reverse Shoulder Prothesis

Treatments

Procedure: Ultrasound

Study type

Interventional

Funder types

Other

Identifiers

NCT05101525
2019-A01483-54

Details and patient eligibility

About

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.

Enrollment

170 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Diagnostic

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

170 participants in 2 patient groups

Patient with effective tendon healing
Experimental group
Treatment:
Procedure: Ultrasound
Patient without tendon healing
Active Comparator group
Treatment:
Procedure: Ultrasound

Trial contacts and locations

1

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Central trial contact

Marie-Hélène Barba; Jean-François Oudet

Data sourced from clinicaltrials.gov

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