NCT05047744

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

September 15, 2019

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

September 8, 2021

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 17, 2021

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

August 22, 2022

Status Verified

August 1, 2022

Enrollment Period

4.3 years

First QC Date

September 8, 2021

Last Update Submit

August 19, 2022

Conditions

Rhizarthrosis

Keywords

CMC I Osteoarthritis, Total Joint Replacement, Hand Surgery

Outcome Measures

Primary Outcomes (1)

  • 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 (1)

  • Subjective Pain

    24 months

Study Arms (1)

Prosthesis Cohort

EXPERIMENTAL

Surgery dual mobility Prosthesis

Device: Touch Dual Mobility CMC I Prosthesis

Interventions

Touch Dual Mobility CMC I ProsthesisDEVICE

Surgery

Prosthesis Cohort

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • CMC I Osteoarthritis /Stage III)

You may not qualify if:

  • CMC I (osteoarthritis / Other Stage than III)
  • Anticoagulation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kepler Universitaetsklinikum GmbH

Linz, 4020, Austria

RECRUITING

Central Study Contacts

Stefan M Froschauer, MD

CONTACT

004373278061020stefan.froschauer@kepleruniklinikum.at

Oskar Kwasny, Prof

CONTACT

004373278061010oskar.kwasny@kepleruniklinikum.at

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Prospective non randomized Clinical Trial
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 8, 2021

First Posted

September 17, 2021

Study Start

September 15, 2019

Primary Completion

December 31, 2023

Study Completion

December 31, 2023

Last Updated

August 22, 2022

Record last verified: 2022-08

Locations

AU(1)