Evaluation of Staple Watson Wrist Arthrodesis

NCT ID: NCT04235972

Last Updated: 2023-05-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

41 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-08-03

Study Completion Date

2021-01-07

Brief Summary

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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

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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.

Conditions

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Osteoarthritis Wrist

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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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.

Group Type OTHER

Follow-up consultation

Intervention Type 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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Rennes University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Warren KIM, MD

Role: STUDY_DIRECTOR

CHU Rennes

Locations

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CHU de Rennes

Rennes, , France

Site Status

Countries

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France

References

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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.

Reference Type RESULT
PMID: 34851782 (View on PubMed)

Other Identifiers

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2019-A01553-54

Identifier Type: OTHER

Identifier Source: secondary_id

35RC19_8861

Identifier Type: -

Identifier Source: org_study_id

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