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In vivo RSA analysis of total joint arthroplasty of the trapezio metacarpal joint of the thumb

In vivo RSA analysis of total joint arthroplasty of the trapezio metacarpal joint of the thumb - RSA CMC I osteoarthritis

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON39108
Enrollment
10
Registered
2008-05-27
Start date
2008-06-02
Completion date
Unknown
Last updated
2024-06-18

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

Conditions

osteoarthrosis prosthesis

Interventions

Intervention: Placement of the SR-TMC prosthesis and insertion of tantalum beads during the surgery.

Sponsors

Reinier de Graaf Groep
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Radiological staged TMC osteoarthritis Eaton and Littler advanced stage 2 to early 4.

Exclusion criteria

Exclusion criteria: Patients with severe instability of the TMC joint.

Design outcomes

Primary

MeasureTime frame
Main study parameters/endpoints: RSA will be used to assess stability of the prosthesis. Outcome will be clinically measured using the VAS score, DASH score and Nelson Hospital Score whilst radiographic outcomes will be evaluated through standard radiographic parameters which include qualitative trapezium and 1st metacarpal bone findings as well as position of the components of the prosthesis.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)