Evaluation of Staple Watson Wrist Arthrodesis

Osteoarthritis Wrist Clinical Trial

— ESWWA  

Official title:

Evaluation of Staple Watson Wrist Arthrodesis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04235972
• Other study ID #: 35RC19_8861
• Secondary ID: 2019-A01553-54
• Status: Completed
• Phase: N/A
• Start date: August 3, 2020
• Est. completion date: January 7, 2021

Study information

• Verified date: May 2023
• Source: Rennes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: January 7, 2021
• Est. primary completion date: January 7, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis Wrist

Intervention

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.

Locations

Country	Name	City	State
France	CHU de Rennes	Rennes

Sponsors (1)

Lead Sponsor	Collaborator
Rennes University Hospital

Country where clinical trial is conducted

France, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Grip force	Change of the grip force measured by Jamar's hydraulic dynamometer, compared to pre-operative assessment	Day 1
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Mean mobility arc	Measurement of the arc of mobility in flexion - extension by goniometer	Day 1