Evaluation of Staple Watson Wrist Arthrodesis (ESWWA)

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.

Study Overview

• Status: Completed
• Conditions: Osteoarthritis Wrist
• Intervention / Treatment: Other: Follow-up consultation

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 Type: Interventional
• Enrollment (Actual): 41
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Rennes, France, 35033
    • CHU de Rennes

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Arthrodesis surgery patients; 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.	Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of the surgical procedure	Assessement of the bones consolidation at at least 6 weeks post-surgery, using a radiological criterion : 3 out of 4 line spacing merged	Day 1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain assessment	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	Day 1
Grip force	Change of the grip force measured by Jamar's hydraulic dynamometer, compared to pre-operative assessment	Day 1
Functional assessment of the wrist with Mayo Wrist Score	International validated functional score. This evaluation yields a total score out of 100 points qualified as poor if <65 up to Excellent if >90.	Day 1
Functional assessment of the wrist with Quick Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire	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	Day 1
Functional assessment of the wrist with Patient-Rated Wrist Evaluation	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	Day 1
Patient's overall satisfaction about surgery	Patient's overall satisfaction assessed by the question: "Would you do the surgery again? (balance between 0 and 10)"	Day 1
Material hindrance	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	Day 1
Mean mobility arc	Measurement of the arc of mobility in flexion - extension by goniometer	Day 1

Collaborators and Investigators

• Sponsor: Rennes University Hospital
• Investigators: Study Director: Warren KIM, MD, Chu Rennes

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): August 3, 2020
• Primary Completion (Actual): January 7, 2021
• Study Completion (Actual): January 7, 2021

Study Registration Dates

• First Submitted: December 26, 2019
• First Submitted That Met QC Criteria: January 16, 2020
• First Posted (Actual): January 22, 2020

Study Record Updates

• Last Update Posted (Actual): May 23, 2023
• Last Update Submitted That Met QC Criteria: May 22, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: orthopaedic surgery; Staples
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis
• Other Study ID Numbers: 35RC19_8861; 2019-A01553-54 (Other Identifier: Id-RCB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No