Evaluation of Staple Watson Wrist Arthrodesis
- Conditions
- Osteoarthritis Wrist
- Interventions
- Other: Follow-up consultation
- Registration Number
- NCT04235972
- Lead Sponsor
- Rennes University Hospital
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 41
- 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
- Refusal to participate after information
- Protected adults
- Person deprived of liberty
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Arthrodesis surgery patients Follow-up consultation A follow-up consultation is organized which includes: A clinical examination with standard data collection as well as a face and profile radiograph of the operated wrist.
- Primary Outcome Measures
Name Time Method Assessment of the surgical procedure 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 Outcome Measures
Name Time Method Grip force Day 1 Change of the grip force measured by Jamar's hydraulic dynamometer, compared to pre-operative assessment
Functional assessment of the wrist with Quick Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire Day 1 International validated functional score. The Quick DASH tool uses a 5-point Likert scale from which the patient can select an appropriate number corresponding to his/her severity level/ function level
Functional assessment of the wrist with Patient-Rated Wrist Evaluation Day 1 International validated functional score. The Patient-Rated Wrist Evaluation (PRWE) allows patients to rate their levels of wrist pain and disability from 0 to 10
Functional assessment of the wrist with Mayo Wrist Score Day 1 International validated functional score. This evaluation yields a total score out of 100 points qualified as poor if \<65 up to Excellent if \>90.
Patient's overall satisfaction about surgery Day 1 Patient's overall satisfaction assessed by the question: "Would you do the surgery again? (balance between 0 and 10)"
Mean mobility arc Day 1 Measurement of the arc of mobility in flexion - extension by goniometer
Material hindrance Day 1 Specific items assessed during clinical evaluations. Quoted as 1 if at least one of the following events is evoked : Material-related pain, skin irritation, re-intervention for remote ablation
Pain assessment Day 1 Evolution in pain reported by the patient by a pain assessment scale, with reference to preoperative assessment.
Evaluation is based on the visual analog scale (VAS) in which the patients select a whole number (0-10 integers) that best reflects the intensity of their pain
Trial Locations
- Locations (1)
CHU de Rennes
🇫🇷Rennes, France