Back to resultsDual Mobility Total Joint Prosthesis (Touch) for Thumb Carpometacarpal Joint Osteoarthritis
Primary Purpose
Rhizarthrosis
Status
Recruiting
Phase
Not Applicable
Locations
Austria
Study Type
Interventional
Intervention
Touch Dual Mobility CMC I Prosthesis
Sponsored by
About this trial
This is an interventional treatment trial for Rhizarthrosis focused on measuring CMC I Osteoarthritis, Total Joint Replacement, Hand Surgery
Eligibility Criteria
Inclusion Criteria:
- CMC I Osteoarthritis /Stage III)
Exclusion Criteria:
- CMC I (osteoarthritis / Other Stage than III)
- Anticoagulation
Sites / Locations
- Kepler Universitaetsklinikum GmbHRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Prosthesis Cohort
Arm Description
Surgery dual mobility Prosthesis
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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
Full Information
NCT ID
NCT05047744
First Posted
September 8, 2021
Last Updated
August 19, 2022
Sponsor
Kepler University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05047744
Brief Title
Dual Mobility Total Joint Prosthesis (Touch) for Thumb Carpometacarpal Joint Osteoarthritis
Official Title
Dual Mobility Total Joint Prosthesis (Touch) for Thumb Carpometacarpal Joint Osteoarthritis
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 15, 2019 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kepler University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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
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.
The Study is designed to give clinical results after one year, 2 years and also long time results in the future.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rhizarthrosis
Keywords
CMC I Osteoarthritis, Total Joint Replacement, Hand Surgery
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Prospective non randomized Clinical Trial
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Prosthesis Cohort
Arm Type
Experimental
Arm Description
Surgery dual mobility Prosthesis
Intervention Type
Device
Intervention Name(s)
Touch Dual Mobility CMC I Prosthesis
Intervention Description
Surgery
Primary Outcome Measure Information:
Title
DASH Score (Disability of Arm Shoulder and Hand Score)
Description
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
Time Frame
24 months
Secondary Outcome Measure Information:
Title
Subjective Pain
Description
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
Time Frame
24 months
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
CMC I Osteoarthritis /Stage III)
Exclusion Criteria:
CMC I (osteoarthritis / Other Stage than III)
Anticoagulation
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Stefan M Froschauer, MD
Phone
004373278061020
Email
stefan.froschauer@kepleruniklinikum.at
First Name & Middle Initial & Last Name or Official Title & Degree
Oskar Kwasny, Prof
Phone
004373278061010
Email
oskar.kwasny@kepleruniklinikum.at
Facility Information:
Facility Name
Kepler Universitaetsklinikum GmbH
City
Linz
ZIP/Postal Code
4020
Country
Austria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stefan M Froschauer, MD
Phone
+4373278061020
Email
stefan.froschauer@kepleruniklinikum.at
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Dual Mobility Total Joint Prosthesis (Touch) for Thumb Carpometacarpal Joint Osteoarthritis
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