Back to resultsImprovement of Implant Survival in Total Joint Arthroplasty of the Trapeziometacarpal Joint
Primary Purpose
Osteoarthritis
Status
Unknown status
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Total joint arthroplasty
Sponsored by
About this trial
This is an interventional treatment trial for Osteoarthritis focused on measuring total joint arthroplasty, thumb, trapeziometacarpal joint, osteoarthritis
Eligibility Criteria
Inclusion Criteria:
- Patients with Eaton type 2+3 TMC osteoarthritis
Exclusion Criteria:
- Patients with Eaton type 4 TMC osteoarthritis
Sites / Locations
- Department of Orthopaedics, Regional Hospital HolstebroRecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Patient cohort
Arm Description
TMC total joint arthroplasty
Outcomes
Primary Outcome Measures
Implant survival
Revision with removal of implant
Secondary Outcome Measures
Full Information
NCT ID
NCT01554748
First Posted
March 12, 2012
Last Updated
February 11, 2020
Sponsor
Regional Hospital Holstebro
1. Study Identification
Unique Protocol Identification Number
NCT01554748
Brief Title
Improvement of Implant Survival in Total Joint Arthroplasty of the Trapeziometacarpal Joint
Official Title
Improvement of Implant Survival in Total Joint Arthroplasty of the Trapeziometacarpal Joint
Study Type
Interventional
2. Study Status
Record Verification Date
February 2020
Overall Recruitment Status
Unknown status
Study Start Date
January 2008 (undefined)
Primary Completion Date
January 2023 (Anticipated)
Study Completion Date
January 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Regional Hospital Holstebro
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The study evaluates implant survival in total joint arthroplasty of the Trapeziometacarpal (TMC) joint by monitoring the survival of different implant types using radiostereometry (RSA) evaluation of the implants.
Detailed Description
The study evaluates implant survival and clinical outcome in total joint arthroplasty of the TMC joint. Different implant designs are included in the study both cemented and uncemented implants. Also the influence of patient factors and surgical technique on implant survival is investigated. The primary outcome is implant migration and loosening. Evaluation is done by monitoring migration and loosening of different implant types using RSA evaluation of the implants. Secondary outcomes are patient reported function evaluated with the Disability of the arm, shoulder and hand score (DASH) and visual analog pain score (VAS). Tertiary outcome is range of movement (ROM) plus grip strength.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis
Keywords
total joint arthroplasty, thumb, trapeziometacarpal joint, osteoarthritis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Implantation of TMC total joint arthroplasty in a patient cohort
Masking
None (Open Label)
Allocation
N/A
Enrollment
400 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Patient cohort
Arm Type
Other
Arm Description
TMC total joint arthroplasty
Intervention Type
Procedure
Intervention Name(s)
Total joint arthroplasty
Primary Outcome Measure Information:
Title
Implant survival
Description
Revision with removal of implant
Time Frame
10 year survival
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients with Eaton type 2+3 TMC osteoarthritis
Exclusion Criteria:
Patients with Eaton type 4 TMC osteoarthritis
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Torben B. Hansen, MD, PhD
Organizational Affiliation
Orthopaedic Research Unit Regional Hospital Holstebro
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Orthopaedics, Regional Hospital Holstebro
City
Holstebro
ZIP/Postal Code
DK-7500
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Torben B. Hansen, MD, PhD
Email
torbehns@rm.dk
First Name & Middle Initial & Last Name & Degree
Torben B. Hansen, MD, PhD
12. IPD Sharing Statement
Citations:
PubMed Identifier
32228611
Citation
Mosegaard SB, Stilling M, Hansen TB. Risk factors for limited improvement after total trapeziometacarpal joint arthroplasty. Health Qual Life Outcomes. 2020 Mar 30;18(1):90. doi: 10.1186/s12955-020-01333-z.
Results Reference
derived
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Improvement of Implant Survival in Total Joint Arthroplasty of the Trapeziometacarpal Joint
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