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Evaluation of Staple Watson Wrist Arthrodesis (ESWWA)

Primary Purpose

Osteoarthritis Wrist

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Follow-up consultation
Sponsored by
Rennes University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Osteoarthritis Wrist focused on measuring orthopaedic surgery, Staples

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • CHU de Rennes

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Arthrodesis surgery patients

Arm Description

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
Grip force
Change of the grip force measured by Jamar's hydraulic dynamometer, compared to pre-operative assessment
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.
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
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
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)"
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
Mean mobility arc
Measurement of the arc of mobility in flexion - extension by goniometer

Full Information

First Posted
December 26, 2019
Last Updated
May 22, 2023
Sponsor
Rennes University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04235972
Brief Title
Evaluation of Staple Watson Wrist Arthrodesis
Acronym
ESWWA
Official Title
Evaluation of Staple Watson Wrist Arthrodesis
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
August 3, 2020 (Actual)
Primary Completion Date
January 7, 2021 (Actual)
Study Completion Date
January 7, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rennes University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis Wrist
Keywords
orthopaedic surgery, Staples

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
41 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arthrodesis surgery patients
Arm Type
Other
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Follow-up consultation
Intervention Description
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 Measure Information:
Title
Assessment of the surgical procedure
Description
Assessement of the bones consolidation at at least 6 weeks post-surgery, using a radiological criterion : 3 out of 4 line spacing merged
Time Frame
Day 1
Secondary Outcome Measure Information:
Title
Pain assessment
Description
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
Time Frame
Day 1
Title
Grip force
Description
Change of the grip force measured by Jamar's hydraulic dynamometer, compared to pre-operative assessment
Time Frame
Day 1
Title
Functional assessment of the wrist with Mayo Wrist Score
Description
International validated functional score. This evaluation yields a total score out of 100 points qualified as poor if <65 up to Excellent if >90.
Time Frame
Day 1
Title
Functional assessment of the wrist with Quick Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire
Description
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
Time Frame
Day 1
Title
Functional assessment of the wrist with Patient-Rated Wrist Evaluation
Description
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
Time Frame
Day 1
Title
Patient's overall satisfaction about surgery
Description
Patient's overall satisfaction assessed by the question: "Would you do the surgery again? (balance between 0 and 10)"
Time Frame
Day 1
Title
Material hindrance
Description
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
Time Frame
Day 1
Title
Mean mobility arc
Description
Measurement of the arc of mobility in flexion - extension by goniometer
Time Frame
Day 1

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Warren KIM, MD
Organizational Affiliation
CHU Rennes
Official's Role
Study Director
Facility Information:
Facility Name
CHU de Rennes
City
Rennes
ZIP/Postal Code
35033
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34851782
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.
Results Reference
result

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Evaluation of Staple Watson Wrist Arthrodesis

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