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Completed

NCT Number: NCT04235972

Evaluation of Staple Watson Wrist Arthrodesis

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.

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Key information

Conditions

Osteoarthritis Wrist

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU de Rennes

Rennes, 35033, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Assessment of the surgical procedure

    Time frame: Day 1

    Assessement of the bones consolidation at at least 6 weeks post-surgery, using a radiological criterion : 3 out of 4 line spacing merged

Secondary outcomes

  1. Pain assessment

    Time frame: Day 1

    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

  2. Grip force

    Time frame: Day 1

    Change of the grip force measured by Jamar's hydraulic dynamometer, compared to pre-operative assessment

  3. Functional assessment of the wrist with Mayo Wrist Score

    Time frame: Day 1

    International validated functional score. This evaluation yields a total score out of 100 points qualified as poor if <65 up to Excellent if >90.

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

    Time frame: Day 1

    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

  5. Functional assessment of the wrist with Patient-Rated Wrist Evaluation

    Time frame: Day 1

    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

  6. Patient's overall satisfaction about surgery

    Time frame: Day 1

    Patient's overall satisfaction assessed by the question: "Would you do the surgery again? (balance between 0 and 10)"

  7. Material hindrance

    Time frame: Day 1

    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

  8. Mean mobility arc

    Time frame: Day 1

    Measurement of the arc of mobility in flexion - extension by goniometer

Sponsors and collaborators

Lead sponsor

Rennes University Hospital

Other

Registry information

Acronym: ESWWA

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jan 22, 2020
Registry last updated
May 23, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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