NCT04702139CompletedNot Applicable
Use of the "Game-Ready" Splint for Better Recovery in Primary Total Shoulder Arthroplasty
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Clinique Bizet
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- the level of postoperative pain following the installation of the Game Ready
Study Overview
Brief Summary
The aim of the study is to compare the level of postoperative pain after fitting the Game Ready splint, at 48 hours versus that observed with fitting a standard splint
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •First-line reverse prosthesis
- •Without prosthetic history
- •Patient who has given his consent to participate in the observational study after being informed by the surgeon
- •Patient living in France and able to answer the questionnaire alone.
- •Subject affiliated to a social security scheme or beneficiary of such a scheme
- •Lack of participation in another clinical study
Exclusion Criteria
- •Minor patient
- •Major subject protected by law, under curatorship or tutorship
- •Anterior prosthesis
- •Parkinson's, degenerative neurological disease
- •Pregnant or breastfeeding woman
Arms & Interventions
patient with game-ready splint
Active Comparator
Installation of the Game-Ready splint immediately after surgery for 12 hours. They will then be put on the standard splint which they will keep for 2 weeks as for the other group but without ice packs.
Intervention: shoulder arthroplastis (Device)
patient with standard splint
Placebo Comparator
Placement of a standard splint immediately after surgery for 2 weeks with ice packs to be used for an average of 8 days.
Intervention: shoulder arthroplastis (Device)
Outcomes
Primary Outcomes
the level of postoperative pain following the installation of the Game Ready
Time Frame: 9 months
Visual Analog Score for pain
Secondary Outcomes
- risk of stiffness(up to 9 months)
- occurrence of hematoma, edema(up to 9 months)
- length of hospitalization(up to 24 hours)
- the time limit for returning to a possible professional activity(up to 3 months)
- evolution of mobility(up to 9 months)
Investigators
Study Sites (1)
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