Dual Mobility Total Joint Prosthesis (Touch) for Thumb Ca... | NCT05047744

Studies
Dual Mobility Total Joint Prosthesis (Touch) for Thumb Carpometacarpal Joint Osteoarthritis

NCT05047744

Sponsor

Kepler University Hospital

Status

Unknown status

Last Update Posted

Aug 22, 2022Actual

Enrollment

100Estimated

Phase

Not Applicable

Conditions

Rhizarthrosis

Interventions

Touch Dual Mobility CMC I Prosthesis

Countries

Austria

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

Aug 2022

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 15, 2019Actual

Primary Completion Date

Dec 31, 2023Estimated

Completion Date

Dec 31, 2023Estimated

First Submitted Date

Sep 8, 2021

First Submission Date that Met QC Criteria

Sep 8, 2021

First Posted Date

Sep 17, 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

Aug 19, 2022

Last Update Posted Date

Aug 22, 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

The dual mobility concept currently represents the newest generation of thumb carpometacarpal prostheses. The aim of this study was to evaluate the outcomes of TOUCH® prosthesis. From September 2019 to December 2023,a minimum of 100 prosthesis shall be implanted in patients suffering from symptomatic stage III osteoarthritis. All included patients will follow a systematic follow-up regimen (4, 8, 16 weeks, 6, and 12 months as well as 24 months postoperatively).

Radiographics, ROM, VAS, DASH and Pinch grip are measured. Aim of the study is to compare clinical outcome of dual mobility prosthesis with common results of CMC I Prosthesis in literature.

Detailed Description

Radiographics, ROM, VAS, DASH and Pinch grip are measured. Aim of the study is to compare clinical outcome of dual mobility prosthesis with common results of CMC I Prosthesis in literature.

The Study is designed to give clinical results after one year, 2 years and also long time results in the future.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Prosthesis Cohort	Experimental	Surgery dual mobility Prosthesis	Device: Touch Dual Mobility CMC I Prosthesis

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Touch Dual Mobility CMC I Prosthesis	Device	Surgery	Prosthesis Cohort

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
DASH Score (Disability of Arm Shoulder and Hand Score)	DASH Score is taken before Surgery and after 6, 12 and 24 months DASH (Disabilty of Arm Shoulder and Hand) Score reaches from 0-100, whereas 0 reprensents best score while 100 represents worst	24 months

Secondary Outcomes

Measure	Description	Time Frame
Subjective Pain	patients report about subjective Pain level in average at 6, 12 and 24 months in a VAS (Visual Analog Pain Scale) scale (0-10), whereas 0 is best and 10 worst	24 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

CMC I Osteoarthritis /Stage III)

Exclusion Criteria:

CMC I (osteoarthritis / Other Stage than III)
Anticoagulation

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

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Stefan M Froschauer, MD	Contact	004373278061020		stefan.froschauer@kepleruniklinikum.at
Oskar Kwasny, Prof	Contact	004373278061010		oskar.kwasny@kepleruniklinikum.at

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Kepler Universitaetsklinikum GmbH	Recruiting	Linz		4020	Austria

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided