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

This study is currently recruiting participants.
Verified March 2012 by Regional Hospital Holstebro
Sponsor:
Information provided by (Responsible Party):
Torben B. Hansen, Regional Hospital Holstebro
ClinicalTrials.gov Identifier:
NCT01554748
First received: March 12, 2012
Last updated: March 19, 2012
Last verified: March 2012

March 12, 2012
March 19, 2012
January 2008
January 2018   (final data collection date for primary outcome measure)
Implant survival [ Time Frame: 10 year survival ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01554748 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
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
Phase 4
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Osteoarthritis
Other: implant fixation with different techniques and designs
implant fixation cemented/uncemented
implant fixation
implant fixation with different techniques
Intervention: Other: implant fixation with different techniques and designs
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
100
January 2019
January 2018   (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
Both
18 Years to 80 Years
No
Not Provided
Denmark
 
NCT01554748
2012-01
Yes
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
March 2012

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