Healing of the Subscapularis, Reverse Shoulder Prothesis
Conditions
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.
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.
Sponsors
European Clinical Trial Experts Network
Ramsay Générale de Santé
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mobility of internal rotation evaluation | 12 months | 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) |
| Tendon healing assessment | 12 months | 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 |
Countries
France
Contacts
Primary ContactJean-François Oudet
Backup ContactMarie-Hélène Barba
Outcome results
None listed