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Status unknownNCT05101525CICASCAPUpdated Nov 1, 2021

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

An interventional study of Ultrasound in Reverse Shoulder Prothesis and Healing of the Subscapularis, sponsored by Ramsay Générale de Santé. Status unknown at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-11-01.

Sponsored by Ramsay Générale de Santé · Not applicable, Interventional, and Diagnostic

The sponsor has not verified this record recently (last verified Oct 2021), so the status shown — last known as Recruiting — may be out of date.

From the registry’s dates

  • Registered 7 months after the study started (first participant enrolled Mar 2021, registered Oct 2021).
Phase
Not applicable
Study type
Interventional
Enrollment
170
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Reverse Shoulder Prothesis
  • Healing of the Subscapularis
03

In context

Lead sponsor

Ramsay Générale de Santé is the lead sponsor of 42 studies on the registry; 10 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
170 participants (estimated)

Study arms

  • Experimental
    Patient with effective tendon healing

    Procedure: Ultrasound

  • Active comparator
    Patient without tendon healing

    Procedure: Ultrasound

Interventions

  • ProcedureUltrasound

    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.

06

What researchers measure

Primary outcomes

  1. 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)

    Time frame: 12 months

  2. 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

    Time frame: 12 months

07

Study locations

1 of 1 sites recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 1, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05101525
Lead sponsor
Ramsay Générale de Santé
Collaborators
European Clinical Trial Experts Network
Responsible party
Sponsor
First posted
Nov 1, 2021
Start date
Mar 9, 2021
Primary completion
Mar 9, 2023 (estimated)
Completion
Mar 9, 2025 (estimated)
Last update
Nov 1, 2021

Study contacts

Jean-François Oudet
Contact
jf.oudet@ecten.eu
0683346567
Marie-Hélène Barba
Contact
mh.barba@ecten.eu

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Oct 2021. You cannot join it, but the record below documents what was studied.

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