Patient Satisfaction After Silicone Metacarpophalangeal Arthroplasty

NCT ID: NCT03626116

Last Updated: 2019-04-05

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

COMPLETED

Total Enrollment

42 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-07-18

Study Completion Date

2018-12-19

Brief Summary

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The primary objective of this study is to identify determinants of long-term patient satisfaction after hand reconstruction using silicone metacarpophalangeal arthroplasty (SMPA). The investigators hypothesize that appearance of the hand, ulnar drift, range of motion, pain, hand function and intake of the newer antirheumatic drugs (i.e. biologicals) influence patient satisfaction.

Detailed Description

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This is an ambidirectional, monocenter research project consisting of a retrospective chart review and a prospective cohort project.

Participants fulfilling all of the following inclusion criteria are eligible for the project:

* Patients with rheumatoid Arthritis (RA) / Psoriasisarthritis / Lupus erythomatodes who had a SMPA between Jan 2007 and one year before the project examination
* Informed Consent as documented by signature

The presence of any one of the following exclusion criteria will lead to exclusion of the participant:

* Major surgery at another joint at the hand (e.g. proximal interphalangeal (PIP) joint arthroplasty, thumb trapeziectomy) less than 6 months ago
* Legal incompetence
* German language barrier to complete the questionnaires

Conditions

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Rheumatoid Arthritis - Hand Joint

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Interventions

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silicone metacarpophalangeal arthroplasty (SMPA)

Replacement of the metacarpophalangeal (MCP) joint using a silicone arthroplasty

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Patients with RA / Psoriasisarthritis / Lupus erythomatodes who had a SMPA between Jan 2007 and one year before the project examination
* Informed Consent as documented by signature

Exclusion Criteria

* Major surgery at another joint at the hand (e.g. PIP arthroplasty, thumb trapeziectomy) less than 6 months ago
* Legal incompetence
* German language barrier to complete the questionnaires
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Schulthess Klinik

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Stephan Schindele, MD

Role: PRINCIPAL_INVESTIGATOR

Schulthess Klinik

Locations

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Schulthess Klinik

Zurich, , Switzerland

Site Status

Countries

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Switzerland

Other Identifiers

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MCP Arthroplasty RA patients

Identifier Type: -

Identifier Source: org_study_id

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