Patient Satisfaction After Silicone Metacarpophalangeal Arthroplasty

Completed

• Conditions: Rheumatoid Arthritis - Hand Joint

• Registration Number: NCT03626116
• Lead Sponsor: Schulthess Klinik

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

Study Timeline

• Study Start: 2018-07-18
• Study First Submitted: 2018-07-19
• Study First Submitted QC: 2018-08-07
• Study First Posted: 2018-08-10
• Primary Completion: 2018-12-19
• Study Completion: 2018-12-19
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-03
• Last Update Posted: 2019-04-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 42

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Satisfaction with the treatment result assessed on a 5-point Likert Scale	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).

Trial Locations

Locations (1)

Schulthess Klinik; 🇨🇭 Zurich, Switzerland