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

Tracking Information
First Submitted Date ICMJE	March 12, 2012
First Posted Date ICMJE	March 15, 2012
Last Update Posted Date	February 22, 2018
Study Start Date ICMJE	January 2008
Estimated Primary Completion Date	January 2023 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: March 13, 2012)	Implant survival [ Time Frame: 10 year survival ]
Original Primary Outcome Measures ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01554748 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE	Not Provided
Original Secondary Outcome Measures ICMJE	Not Provided
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	Improvement of Implant Survival in Total Joint Arthroplasty of the Trapeziometacarpal Joint
Official Title ICMJE	Improvement of Implant Survival in Total Joint Arthroplasty of the Trapeziometacarpal Joint
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.
Study Type ICMJE	Interventional
Study Phase	Not Applicable
Study Design ICMJE	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
Condition ICMJE	Osteoarthritis
Intervention ICMJE	Procedure: Total joint arthroplasty
Study Arms	Patient cohort; TMC total joint arthroplasty; Intervention: Procedure: Total joint arthroplasty
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Recruiting
Estimated Enrollment ICMJE; (submitted: February 20, 2018)	400
Original Estimated Enrollment ICMJE; (submitted: March 13, 2012)	100
Estimated Study Completion Date	January 2023
Estimated Primary Completion Date	January 2023 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	Inclusion Criteria: Patients with Eaton type 2+3 TMC osteoarthritis Exclusion Criteria: Patients with Eaton type 4 TMC osteoarthritis
Sex/Gender	Sexes Eligible for Study: All
Ages	18 Years to 80 Years (Adult, Older Adult)
Accepts Healthy Volunteers	No
Contacts ICMJE
Listed Location Countries ICMJE	Denmark
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT01554748
Other Study ID Numbers ICMJE	2012-01
Has Data Monitoring Committee	Yes
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Torben B. Hansen, Regional Hospital Holstebro
Study Sponsor ICMJE	Regional Hospital Holstebro
Collaborators ICMJE	Not Provided
Investigators ICMJE	Principal Investigator: Torben B. Hansen, MD, PhD Orthopaedic Research Unit Regional Hospital Holstebro
PRS Account	Regional Hospital Holstebro
Verification Date	February 2018
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP