RhizarthrosisPSRNCT06555250
Interest of Bone Scintigraphy in the Search for Scaphotrapezoidal Osteoarthritis
An observational study of Rhizarthrosis and Prosthesis Failure, run by University Hospital, Brest at 1 site in France.
Trial summary
Rhizarthosis can be treated by prothesis of the carpo-metacarpal (CM) joint of the thumb. But, if the scaphotrapeziotrapezoid (STT) joint is also affected by arthrosis, treating the CM joint exclusively may result in partial pain relief. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Rhizarthrosis, Prosthesis Failure
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- 15 Jun 2021to 31 Oct 2023
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patient who beneficiate of a bone scintigraphy before arthroplasty for rhizarthrosis with failure medical treatment, without osteoarthritis of the STT joint on planar radiography
Who may be able to join
- failure of medical treatment of rhizarthrosis
- eligibility for prothesis
- no osteoarthritis of the STT joint on planar radiography
- no opposition from the patient
Who cannot join
- Refusal by a patient
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Interest of Bone Scintigraphy in the Search for Scaphotrapezoidal Osteoarthritis in the Context of Preoperative Assessment of Rhizarthrosi
Rhizarthosis can be treated by prothesis of the carpo-metacarpal (CM) joint of the thumb. But, if the scaphotrapeziotrapezoid (STT) joint is also affected by arthrosis, treating the CM joint exclusively may result in partial pain relief. Thus, bone scintigraphy could identify early arthrosis of the STT joint when its appearance seems to be normal on planar radiography, suggesting another surgical procedure.
- Conditions
- Rhizarthrosis, Prosthesis Failure
- Keywords
- rhizarthrosis, bone scintigraphy
- Medical subject headings
- Prosthesis Failure
What is being measured
The primary outcome is the main question the study is designed to answer.
Search for a statistically significant association between scintigraphic STT hyperfixation and residual pain after TM prosthesis for patients with no radiographically obvious STT involvement.
STT scintigraphic hyperfixation and pain before surgery and 4 months after TM arthroplasty
Measured: before surgery and 4 month after surgery
Secondary outcomes (2)
Search for an association between scintigraphic STT hyperfixation in quantitative analysis and residual pain after TM prosthesis for patients without advanced STT involvement on radiography.
SUVmax STT and pain before surgery and 4 months after TM arthroplasty
Measured: before surgery
Assessing the involvement of other carpal joint compartments
Scintigraphic hyperfixation of other carpal joint compartments and pain before surgery and 4 months after TM arthroplasty
Measured: before surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2024
- Study start15 Jun 2021
- Primary completion1 Jun 2023
- Study completion31 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RhizarthrosisStudies of the same condition, open and under way.
- More trials run by University Hospital, BrestThe 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
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06555250
- Sponsor's protocol ID
- 29BRC21.0207 - PSR
- Acronym
- PSR
- Status last verified
- Aug 2024
- First submitted
- 4 Jul 2022
- Last updated
- 15 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All collected data that underlie results in a publication
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interest of Bone Scintigraphy in the Search for Scaphotrapezoidal Osteoarthritis in the Context of Preoperative Assessment of Rhizarthrosi
- ClinicalTrials.gov ID
- NCT06555250
- Acronym / sponsor ID
- PSR / 29BRC21.0207 - PSR
- Conditions
- Rhizarthrosis, Prosthesis Failure
- Keywords
- rhizarthrosis, bone scintigraphy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- 15 Jun 2021 (actual)
- Primary completion
- 1 Jun 2023 (actual)
- Study completion
- 31 Oct 2023 (actual)
- First posted
- 15 Aug 2024 (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.
Rhizarthosis can be treated by prothesis of the carpo-metacarpal (CM) joint of the thumb. But, if the scaphotrapeziotrapezoid (STT) joint is also affected by arthrosis, treating the CM joint exclusively may result in partial pain relief. Thus, bone scintigraphy could identify early arthrosis of the STT joint when its appearance seems to be normal on planar radiography, suggesting another surgical procedure.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patient who beneficiate of a bone scintigraphy before arthroplasty for rhizarthrosis with failure medical treatment, without osteoarthritis of the STT joint on planar radiography
Key inclusion criteria (4 listed)
- failure of medical treatment of rhizarthrosis
- eligibility for prothesis
- no osteoarthritis of the STT joint on planar radiography
- no opposition from the patient
Key exclusion criteria (1 listed)
- Refusal by a patient
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
Search for a statistically significant association between scintigraphic STT hyperfixation and residual pain after TM prosthesis for patients with no radiographically obvious STT involvement.
Time frame: before surgery and 4 month after surgery
STT scintigraphic hyperfixation and pain before surgery and 4 months after TM arthroplasty
2 secondary outcomes
Search for an association between scintigraphic STT hyperfixation in quantitative analysis and residual pain after TM prosthesis for patients without advanced STT involvement on radiography.
Time frame: before surgery
Assessing the involvement of other carpal joint compartments
Time frame: before surgery
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 15 Aug 2024.
- Individual participant dataSharing planned: Yes. All collected data that underlie results in a publication
Related trials for Rhizarthrosis
Recruiting
Surgery for Thumb Base Osteoarthritis: Joint Replacement vs. Trapeziectomy
Thumb Osteoarthritis, Thumb Carpometacarpal Joint Osteoarthritis
RecruitingObservational study
Rhizarthrosis Surgery and Functional Recovery: Arthroplasty vs. Trapezectomy
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The Effect of Auriculotherapy on the Treatment of Postoperative Pain in Outpatient Rhizarthrosis Surgery
Thumb Arthritis
Recruiting
High-Energy Laser in the Conservative Treatment of Rhizarthrosis
Thumb Osteoarthritis, Hand Injuries
RecruitingPhase 2
Tolerance of Intra-articular Injection Autologous Stromal Vascular Fraction for the Treatment of Rhizarthrosis
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Rhizarthrosis and Prosthesis Failure, run by University Hospital, Brest 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 4 inclusion and 1 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 15 Aug 2024. 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?
Search for a statistically significant association between scintigraphic STT hyperfixation and residual pain after TM prosthesis for patients with no radiographically obvious STT involvement. (time frame: before surgery and 4 month after surgery). 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 15 Aug 2024.