Clinical trial NCT04235972: Evaluation of Staple Watson Wrist Arthrodesis
Official title: Evaluation of Staple Watson Wrist Arthrodesis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis Wrist
Keywords: orthopaedic surgery
Staples
Lead sponsor: Rennes University Hospital
Sponsor class: OTHER
First posted: 2020-01-22
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Assessment of the surgical procedure
timeFrame: Day 1
Secondary outcomes:
measure: Pain assessment
timeFrame: Day 1
measure: Grip force
timeFrame: Day 1
measure: Functional assessment of the wrist with Mayo Wrist Score
timeFrame: Day 1
measure: Functional assessment of the wrist with Quick Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire
timeFrame: Day 1
measure: Functional assessment of the wrist with Patient-Rated Wrist Evaluation
timeFrame: Day 1
measure: Patient's overall satisfaction about surgery
timeFrame: Day 1
measure: Material hindrance
timeFrame: Day 1
measure: Mean mobility arc
timeFrame: Day 1
Other outcomes:
Locations:
city: Rennes
country: France
facility: CHU de Rennes
Study officials:
affiliation: CHU Rennes
name: Warren KIM, MD
role: STUDY_DIRECTOR
References:
citation: Mevel G, De Geyer A, Kim W, Ebalard M, Ropars M, Dreano T. Four-corner arthrodesis using the 4Fusion(R) quadripodal shape memory staple: a long-term review. J Hand Surg Eur Vol. 2022 Apr;47(4):387-392. doi: 10.1177/17531934211063614. Epub 2021 Dec 1.