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Evaluation of Staple Watson Wrist Arthrodesis

Evaluation of Staple Watson Wrist Arthrodesis

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04235972
Acronym
ESWWA
Enrollment
41
Registered
2020-01-22
Start date
2020-08-03
Completion date
2021-01-07
Last updated
2023-05-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoarthritis Wrist

Keywords

orthopaedic surgery, Staples

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.

Interventions

OTHERFollow-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.

Sponsors

Rennes University Hospital
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frameDescription
Assessment of the surgical procedureDay 1Assessement of the bones consolidation at at least 6 weeks post-surgery, using a radiological criterion : 3 out of 4 line spacing merged

Secondary

MeasureTime frameDescription
Grip forceDay 1Change of the grip force measured by Jamar's hydraulic dynamometer, compared to pre-operative assessment
Functional assessment of the wrist with Mayo Wrist ScoreDay 1International validated functional score. This evaluation yields a total score out of 100 points qualified as poor if \<65 up to Excellent if \>90.
Functional assessment of the wrist with Quick Disabilities of the Arm, Shoulder and Hand (DASH) questionnaireDay 1International 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
Pain assessmentDay 1Evolution 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
Patient's overall satisfaction about surgeryDay 1Patient's overall satisfaction assessed by the question: Would you do the surgery again? (balance between 0 and 10)
Material hindranceDay 1Specific 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
Mean mobility arcDay 1Measurement of the arc of mobility in flexion - extension by goniometer
Functional assessment of the wrist with Patient-Rated Wrist EvaluationDay 1International validated functional score. The Patient-Rated Wrist Evaluation (PRWE) allows patients to rate their levels of wrist pain and disability from 0 to 10

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026