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Clinical Trials/NCT03626116
NCT03626116
Completed
Not Applicable

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

Schulthess Klinik1 site in 1 country42 target enrollmentJuly 18, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Rheumatoid Arthritis - Hand Joint
Sponsor
Schulthess Klinik
Enrollment
42
Locations
1
Primary Endpoint
Satisfaction with the treatment result assessed on a 5-point Likert Scale
Status
Completed
Last Updated
7 years ago

Overview

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

Registry
clinicaltrials.gov
Start Date
July 18, 2018
End Date
December 19, 2018
Last Updated
7 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Satisfaction with the treatment result assessed on a 5-point Likert Scale

Time Frame: at least one year after surgery

The 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).

Study Sites (1)

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