Post-operative Results of the Trapezometacarpal (TMC) Pro... | NCT05169099

Studies
Post-operative Results of the Trapezometacarpal (TMC) Prosthesis for Advanced Pre-operative Deformities

NCT05169099

Sponsor

University Hospital, Montpellier

Status

Completed

Last Update Posted

Feb 8, 2022Actual

Enrollment

400Actual

Phase

Not provided

Conditions

Rhizarthrosis
Arthritis

Interventions

Not provided

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 20, 2014Actual

Primary Completion Date

Jan 1, 2022Actual

Completion Date

Jan 30, 2022Actual

First Submitted Date

Nov 1, 2021

First Submission Date that Met QC Criteria

Dec 22, 2021

First Posted Date

Dec 23, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 7, 2022

Last Update Posted Date

Feb 8, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Trapezometacarpal protheses are implanted for patients with trapezometacarpal arthritis. Having a pre-operative thumb adduction angle of less than 25 degrees with hyperextension, meaning a " Z-deformity " are somehow a reason to go for another surgical treatment: trapezectomy with ligament reconstruction. This study will aim at analyzing the results of another surgical treatment which is the trapezometacarpal arthroplasty in this type of deformities.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

400Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of Participants with Mobility of the trapezometacarpal joint	Mobility of the trapezometacarpal joint	1 day

Secondary Outcomes

Measure	Description	Time Frame
Number of Participants with Grasping force measured	Grasping force measured	1 day
Number of Participants with Pinching force	Pinching force

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion criteria:

Patient with TMC joint arthritis
Patient with adduction <25 degrees
Patients with Z deformity
Patient operated for TMC joint arthroplasty

Exclusion criteria:

- TMC arthroplasty implanted for fractures

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Patients operated with trapezometacarpal joint arthroplasty for trapezometacarpal joint arthritis

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Michel CHAMMAS, PUPH	University Hospital, Montpellier	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Uhmontpellier		Montpellier		34295	France

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D001168	Arthritis

Ancestor Terms

ID	Term
D007592	Joint Diseases
D009140	Musculoskeletal Diseases

Browse Leaves

Not provided

Browse Branches

Not provided