Evaluation of Staple Watson Wrist Arthrodesis

NCT04235972 | Completed

• 2 other identifiers: 35RC19_88612019-A01553-54
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteoarthritis Wrist

Keywords

orthopaedic surgery; Staples

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Pain assessment

  Day 1

• Grip force

  Day 1

• Functional assessment of the wrist with Mayo Wrist Score

  Day 1

• Functional assessment of the wrist with Quick Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire

  Day 1

• Functional assessment of the wrist with Patient-Rated Wrist Evaluation

  Day 1

Study Arms (1)

Arthrodesis surgery patients

OTHER

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

Interventions

Follow-up consultation OTHER

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.

Arthrodesis surgery patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Refusal to participate after information
• Protected adults
• Person deprived of liberty

Sponsors & Collaborators

• Rennes University Hospital: lead

Study Sites (1)

CHU de Rennes

Rennes, 35033, France

Location

Related 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.

  PMID: 34851782 RESULT

Study Officials

• Warren KIM, MD

  CHU Rennes

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 26, 2019
• First Posted: January 22, 2020
• Study Start: August 3, 2020
• Primary Completion: January 7, 2021
• Study Completion: January 7, 2021
• Last Updated: May 23, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)