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Improvement of Implant Survival in Total Joint Arthroplasty of the Trapeziometacarpal Joint

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ClinicalTrials.gov Identifier: NCT01554748
Recruitment Status : Recruiting
First Posted : March 15, 2012
Last Update Posted : February 22, 2018
Sponsor:
Information provided by (Responsible Party):
Torben B. Hansen, Regional Hospital Holstebro

March 12, 2012
March 15, 2012
February 22, 2018
January 2008
January 2023   (Final data collection date for primary outcome measure)
Implant survival [ Time Frame: 10 year survival ]
Same as current
Complete list of historical versions of study NCT01554748 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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Improvement of Implant Survival in Total Joint Arthroplasty of the Trapeziometacarpal Joint
Improvement of Implant Survival in Total Joint Arthroplasty of the Trapeziometacarpal Joint
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.
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.
Interventional
Not Applicable
Intervention Model: Single Group Assignment
Intervention Model Description:
Implantation of TMC total joint arthroplasty in a patient cohort
Masking: None (Open Label)
Primary Purpose: Treatment
Osteoarthritis
Procedure: Total joint arthroplasty
Patient cohort
TMC total joint arthroplasty
Intervention: Procedure: Total joint arthroplasty
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
400
100
January 2023
January 2023   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients with Eaton type 2+3 TMC osteoarthritis

Exclusion Criteria:

  • Patients with Eaton type 4 TMC osteoarthritis
Sexes Eligible for Study: All
18 Years to 80 Years   (Adult, Older Adult)
No
Denmark
 
 
NCT01554748
2012-01
Yes
Not Provided
Not Provided
Torben B. Hansen, Regional Hospital Holstebro
Regional Hospital Holstebro
Not Provided
Principal Investigator: Torben B. Hansen, MD, PhD Orthopaedic Research Unit Regional Hospital Holstebro
Regional Hospital Holstebro
February 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP