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

NCT ID: NCT01554748

Last Updated: 2020-02-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-01-31

Study Completion Date

2023-01-31

Brief Summary

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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

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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.

Conditions

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Osteoarthritis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Implantation of TMC total joint arthroplasty in a patient cohort
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Patient cohort

TMC total joint arthroplasty

Group Type OTHER

Total joint arthroplasty

Intervention Type PROCEDURE

Interventions

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Total joint arthroplasty

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Patients with Eaton type 2+3 TMC osteoarthritis

Exclusion Criteria

* Patients with Eaton type 4 TMC osteoarthritis
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Regional Hospital Holstebro

OTHER

Sponsor Role lead

Responsible Party

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Torben B. Hansen

Professor, MD, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Torben B. Hansen, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Orthopaedic Research Unit Regional Hospital Holstebro

Locations

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Department of Orthopaedics, Regional Hospital Holstebro

Holstebro, , Denmark

Site Status RECRUITING

Countries

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Denmark

Facility Contacts

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Torben B. Hansen, MD, PhD

Role: primary

References

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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.

Reference Type DERIVED
PMID: 32228611 (View on PubMed)

Other Identifiers

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2012-01

Identifier Type: -

Identifier Source: org_study_id

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