Evaluation of Staple Watson Wrist Arthrodesis
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 41
- Locations
- 2
- Primary Endpoint
- Assessment of the surgical procedure
Study Overview
Brief Summary
When the wrist is damaged, for traumatic or degenerative reasons, the cartilage is worn out and the bones rub together: this is osteoarthritis. In order to stop this pain, it may be necessary to block these bones from each other, sacrificing mobility to achieve indolence.
Multiple techniques are described according to the type of osteoarthritis and for each type of osteoarthritis itself, but the principle remains the same. The methods currently commonly proposed are the staple and the screwed plate.
The aim of the study is to evaluate the surgical practice of the Orthopaedics and Traumatology department of the University Hospital of Rennes, and its long-term results, as this type of surgery is intended to be definitive.
Detailed Description
The surgery performed in the Orthopaedics and Traumatology department of the University Hospital of Rennes, has 2 notable points: its technique and its equipment.
- The procedure is based on the staples 4Fusion1 (Stryker/Memometal), which is still poorly assessed in the literature.
- The surgical procedure has several technical specificities: intra osseous cartilage freshening and preservation of the lunotriquetral ligament if intact.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Adult Patients
- •All patients operated on for a 4-bones arthrodesis performed by stapling at the CHU RENNES between 1 January 2008 and 31 December 2017 with 4fusion stapling
- •Patients who gave consent after full information
Exclusion Criteria
- •Refusal to participate after information
- •Protected adults
- •Person deprived of liberty
Outcomes
Primary Outcomes
Assessment of the surgical procedure
Time Frame: Day 1
Assessement of the bones consolidation at at least 6 weeks post-surgery, using a radiological criterion : 3 out of 4 line spacing merged
Secondary Outcomes
- Grip force(Day 1)
- Functional assessment of the wrist with Quick Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire(Day 1)
- Functional assessment of the wrist with Patient-Rated Wrist Evaluation(Day 1)
- Functional assessment of the wrist with Mayo Wrist Score(Day 1)
- Patient's overall satisfaction about surgery(Day 1)
- Mean mobility arc(Day 1)
- Material hindrance(Day 1)
- Pain assessment(Day 1)