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Patient Satisfaction After Silicone Metacarpophalangeal Arthroplasty

What Determines Satisfaction of Patients With Rheumatoid Arthritis After Hand Reconstruction Using Silicone Metacarpophalangeal Arthroplasty

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03626116
Enrollment
42
Registered
2018-08-10
Start date
2018-07-18
Completion date
2018-12-19
Last updated
2019-04-05

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

Conditions

Rheumatoid Arthritis - Hand Joint

Brief summary

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

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

Interventions

PROCEDUREsilicone metacarpophalangeal arthroplasty (SMPA)

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

Sponsors

Schulthess Klinik
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
RETROSPECTIVE

Eligibility

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

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

Design outcomes

Primary

MeasureTime frameDescription
Satisfaction with the treatment result assessed on a 5-point Likert Scaleat least one year after surgeryThe primary outcome is the satisfaction with the treatment result at least one year after surgery and its determinants. It will be quantified using this question: How satisfied are you with the overall result of the SMPA surgery? The response options are: Very satisfied (score 1), somewhat satisfied (score 2), neither satisfied nor unsatisfied (score 3), somewhat unsatisfied (score 4), very unsatisfied (score 5). For further analyses, this question can be dichotomized into the categories of satisfied patients (very satisfied / satisfied) and unsatisfied patients (neither satisfied nor dissatisfied or worse).

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026