Radioscapholunate Fusions After Wrist Trauma (Radioscapho)

December 28, 2020 updated by: University Hospital, Montpellier

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

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)

Study Overview

Status

Completed

Conditions

Detailed Description

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

Study Type

Observational

Enrollment (Actual)

85

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Montpellier, France, 34295
        • Uhmontpellier

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients who had posttraumatic radiocarpal osteoarthritis and underwent RSL fusion

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
presence of mediocarpal osteoarthritis
Time Frame: 1 day
To evaluate the long-term radiographic results of post-traumatic radio scapholunate
1 day
presence of scapho-trapezoidal trapezoid
Time Frame: 1 day
To evaluate the long-term radiographic results of post-traumatic radio scapholunate
1 day
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
1 day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assess overall survival
Time Frame: 1 day
To evaluate the overall survival (excluding total wrist arthrodesis) of post-traumatic radio scapholunate
1 day
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)
1 day
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)
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Montpellier

Collaborators

Central Hospital, Nancy, France

Investigators

  • Principal Investigator: Benjamin Degeorge, University Hospital, Montpellier

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2018

Primary Completion (Actual)

May 1, 2018

Study Completion (Actual)

May 31, 2018

Study Registration Dates

First Submitted

January 24, 2019

First Submitted That Met QC Criteria

February 20, 2019

First Posted (Actual)

February 21, 2019

Study Record Updates

Last Update Posted (Actual)

December 30, 2020

Last Update Submitted That Met QC Criteria

December 28, 2020

Last Verified

December 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RECHMPL19_0010

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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