Posttraumatic Radiocarpal OsteoarthritisRadioscaphoNCT03850249
Radioscapholunate Fusions After Wrist Trauma
An observational study of Posttraumatic Radiocarpal Osteoarthritis, run by University Hospital, Montpellier at 1 site in France.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Posttraumatic Radiocarpal Osteoarthritis
- How many people
- 85 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 2018to 31 May 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who had posttraumatic radiocarpal osteoarthritis and underwent RSL fusion
Who may be able to join
- posttraumatic radiocarpal osteoarthritis
- Patients who underwent radioscapholunate fusion
Who cannot join
- Patients with radiocarpal osteoarthritis due to rheumatoid or inflammatory disease and Kienböck disease
- Patients with posttraumatic radiocarpal osteoarthritis managed with other surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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)
Read the 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
- Conditions
- Posttraumatic Radiocarpal Osteoarthritis
- Keywords
- Radioscapholunate, Fusion, Arthrodesis, Radiocarpal osteoarthritis, Partial radiocarpal fusion
- Medical subject headings
- Ankylosis
What is being measured
The primary outcome is the main question the study is designed to answer.
presence of mediocarpal osteoarthritis
To evaluate the long-term radiographic results of post-traumatic radio scapholunate
Measured: 1 day
presence of scapho-trapezoidal trapezoid
To evaluate the long-term radiographic results of post-traumatic radio scapholunate
Measured: 1 day
presence of non-consolidation of radio-scapho-lunar arthrodesis
To evaluate the long-term radiographic results of post-traumatic radio scapholunate
Measured: 1 day
Secondary outcomes (3)
Assess overall survival
To evaluate the overall survival (excluding total wrist arthrodesis) of post-traumatic radio scapholunate
Measured: 1 day
the prognostic factors of good clinical
To evaluate the prognostic factors of good clinical (ie absence of osteoarthritis or good consolidation of arthrodesis)
Measured: 1 day
the prognostic factors of radiographic evolution
To evaluate the prognostic factors of radiographic evolution (ie absence of osteoarthritis or good consolidation of arthrodesis)
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2019
- Study start1 Jan 2018
- Primary completion1 May 2018
- Study completion31 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Posttraumatic Radiocarpal OsteoarthritisStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 85 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Collaborators
- Central Hospital, Nancy, France
- Responsible party
- Sponsor
- Investigators
- Benjamin Degeorge, Principal investigator, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03850249
- Sponsor's protocol ID
- RECHMPL19_0010
- Acronym
- Radioscapho
- Status last verified
- Dec 2020
- First submitted
- 24 Jan 2019
- Last updated
- 30 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Radioscapholunate Fusions After Wrist Trauma: Long-term Clinical and Radiographic Results.
- ClinicalTrials.gov ID
- NCT03850249
- Acronym / sponsor ID
- Radioscapho / RECHMPL19_0010
- Conditions
- Posttraumatic Radiocarpal Osteoarthritis
- Keywords
- Radioscapholunate, Fusion, Arthrodesis, Radiocarpal osteoarthritis, Partial radiocarpal fusion
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 85 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Collaborators
- Central Hospital, Nancy, France
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 1 May 2018 (actual)
- Study completion
- 31 May 2018 (actual)
- First posted
- 21 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who had posttraumatic radiocarpal osteoarthritis and underwent RSL fusion
Key inclusion criteria (2 listed)
- posttraumatic radiocarpal osteoarthritis
- Patients who underwent radioscapholunate fusion
Key exclusion criteria (2 listed)
- Patients with radiocarpal osteoarthritis due to rheumatoid or inflammatory disease and Kienböck disease
- Patients with posttraumatic radiocarpal osteoarthritis managed with other surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
presence of mediocarpal osteoarthritis
Time frame: 1 day
To evaluate the long-term radiographic results of post-traumatic radio scapholunate
presence of scapho-trapezoidal trapezoid
Time frame: 1 day
To evaluate the long-term radiographic results of post-traumatic radio scapholunate
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
3 secondary outcomes
Assess overall survival
Time frame: 1 day
the prognostic factors of good clinical
Time frame: 1 day
the prognostic factors of radiographic evolution
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2020.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Benjamin Degeorge principal investigator
University Hospital, Montpellier
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Posttraumatic Radiocarpal Osteoarthritis, run by University Hospital, Montpellier at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
presence of mediocarpal osteoarthritis (time frame: 1 day). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Dec 2020.