NCT01554748

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
400

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2008

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2008

Completed
4.2 years until next milestone

First Submitted

Initial submission to the registry

March 12, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 15, 2012

Completed
10.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2023

Completed
Last Updated

February 13, 2020

Status Verified

February 1, 2020

Enrollment Period

15 years

First QC Date

March 12, 2012

Last Update Submit

February 11, 2020

Conditions

Osteoarthritis

Keywords

total joint arthroplastythumbtrapeziometacarpal jointosteoarthritis

Outcome Measures

Primary Outcomes (1)

  • Implant survival

    Revision with removal of implant

    10 year survival

Study Arms (1)

Patient cohort

OTHER

TMC total joint arthroplasty

Procedure: Total joint arthroplasty

Interventions

Total joint arthroplastyPROCEDURE
Patient cohort

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with Eaton type 2+3 TMC osteoarthritis

You may not qualify if:

  • Patients with Eaton type 4 TMC osteoarthritis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Orthopaedics, Regional Hospital Holstebro

Holstebro, DK-7500, Denmark

RECRUITING

Related Publications (1)

  • 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.

    PMID: 32228611DERIVED

MeSH Terms

Conditions

Osteoarthritis

Interventions

Arthroplasty, Replacement

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

ArthroplastyOrthopedic ProceduresSurgical Procedures, OperativePlastic Surgery ProceduresProsthesis Implantation

Study Officials

  • Torben B. Hansen, MD, PhD

    Orthopaedic Research Unit Regional Hospital Holstebro

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Implantation of TMC total joint arthroplasty in a patient cohort
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, MD, PhD

Study Record Dates

First Submitted

March 12, 2012

First Posted

March 15, 2012

Study Start

January 1, 2008

Primary Completion

January 1, 2023

Study Completion

January 1, 2023

Last Updated

February 13, 2020

Record last verified: 2020-02

Locations

DK(1)