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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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01554748
Enrollment
400
Registered
2012-03-15
Start date
2008-01-31
Completion date
2023-01-31
Last updated
2020-02-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoarthritis

Keywords

total joint arthroplasty, thumb, trapeziometacarpal joint, osteoarthritis

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.

Interventions

PROCEDURETotal joint arthroplasty

Sponsors

Regional Hospital Holstebro
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

Implantation of TMC total joint arthroplasty in a patient cohort

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

* Patients with Eaton type 2+3 TMC osteoarthritis

Exclusion criteria

* Patients with Eaton type 4 TMC osteoarthritis

Design outcomes

Primary

MeasureTime frameDescription
Implant survival10 year survivalRevision with removal of implant

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 27, 2026