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

Regional Hospital Holstebro

Status: Unknown

Conditions: Osteoarthritis

Treatments: Procedure: Total joint arthroplasty

Study type: Interventional

Funder types: Other

Identifiers

NCT01554748

2012-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 400 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with Eaton type 2+3 TMC osteoarthritis

Exclusion criteria

• Patients with Eaton type 4 TMC osteoarthritis

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

400 participants in 1 patient group

Patient cohort

Other group

Description:

TMC total joint arthroplasty

Treatment:

Procedure: Total joint arthroplasty