NCT06555250

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2021

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 15, 2021

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

July 4, 2022

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2023

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2023

Completed
10 months until next milestone

First Posted

Study publicly available on registry

August 15, 2024

Completed
Last Updated

August 15, 2024

Status Verified

August 1, 2024

Enrollment Period

2 years

First QC Date

July 4, 2022

Last Update Submit

August 12, 2024

Conditions

Keywords

rhizarthrosisbone scintigraphy

Outcome Measures

Primary Outcomes (1)

  • 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

    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.

    before surgery

  • Assessing the involvement of other carpal joint compartments

    before surgery

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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

You may qualify if:

  • failure of medical treatment of rhizarthrosis
  • eligibility for prothesis
  • no osteoarthritis of the STT joint on planar radiography
  • no opposition from the patient

You may not qualify if:

  • Refusal by a patient

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Brest

Brest, 29609, France

Location

MeSH Terms

Conditions

Prosthesis Failure

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 4, 2022

First Posted

August 15, 2024

Study Start

June 15, 2021

Primary Completion

June 1, 2023

Study Completion

October 31, 2023

Last Updated

August 15, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will share

All collected data that underlie results in a publication

Shared Documents
STUDY PROTOCOL
Time Frame
Data will be available after the publication of result and ending five years maximum following the last visit of the last patient
Access Criteria
Data access requests will be reviewed by the internal committee of Brest UH. requestors will be required to sign and complete a data access agreement

Locations