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Completed

NCT Number: NCT03850249

Radioscapholunate Fusions After Wrist Trauma

The investigators conduced a clinical trial to evaluate the clinical and radiographic results after radioscapholunate fusion in case of posttraumatic radiocarpal osteoarthritis.

Because of poor clinical result, many authors upgrade the procedure including excision of the distal pole of the scaphoid and later excision of the entire triquetrum.

Only one study compared the three procedures in 17 patients. The investigators performed the same comparison in 85 patients with a mean follow up of 9,1 years (1-23)

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Key information

Conditions

Posttraumatic Radiocarpal Osteoarthritis Ankylosis Joint Diseases Musculoskeletal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Uhmontpellier

Montpellier, 34295, France

About this study

The investigators compared three populations: patients with radioscapholunate (RSL) fusion alone, patients with RSLfusion and distal scaphoid excision and patient with RSL fusion, distal scaphoid excision and excision of the triquetrum.

The investigators performed clinical (pain, grasp strength, wrist motion), functional and radiographic (midcarpal osteoarthritis and radiocarpal nonunions) evaluation

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • posttraumatic radiocarpal osteoarthritis
  • Patients who underwent radioscapholunate fusion

Exclusion criteria

  • Patients with radiocarpal osteoarthritis due to rheumatoid or inflammatory disease and Kienböck disease
  • Patients with posttraumatic radiocarpal osteoarthritis managed with other surgery

Treatment and study plan

Primary outcomes

  1. presence of mediocarpal osteoarthritis

    Time frame: 1 day

    To evaluate the long-term radiographic results of post-traumatic radio scapholunate

  2. presence of scapho-trapezoidal trapezoid

    Time frame: 1 day

    To evaluate the long-term radiographic results of post-traumatic radio scapholunate

  3. presence of non-consolidation of radio-scapho-lunar arthrodesis

    Time frame: 1 day

    To evaluate the long-term radiographic results of post-traumatic radio scapholunate

Secondary outcomes

  1. Assess overall survival

    Time frame: 1 day

    To evaluate the overall survival (excluding total wrist arthrodesis) of post-traumatic radio scapholunate

  2. the prognostic factors of good clinical

    Time frame: 1 day

    To evaluate the prognostic factors of good clinical (ie absence of osteoarthritis or good consolidation of arthrodesis)

  3. the prognostic factors of radiographic evolution

    Time frame: 1 day

    To evaluate the prognostic factors of radiographic evolution (ie absence of osteoarthritis or good consolidation of arthrodesis)

Sponsors and collaborators

Lead sponsor

University Hospital, Montpellier

Other

Collaborators

  • Central Hospital, Nancy, France

Registry information

Official study title

Radioscapholunate Fusions After Wrist Trauma: Long-term Clinical and Radiographic Results.

Acronym: Radioscapho

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Feb 21, 2019
Registry last updated
Dec 30, 2020

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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