Patient Satisfaction After Silicone Metacarpophalangeal Arthroplasty

Rheumatoid Arthritis - Hand Joint Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03626116
• Other study ID #: MCP Arthroplasty RA patients
• Status: Completed
• Start date: July 18, 2018
• Est. completion date: December 19, 2018

Study information

• Verified date: April 2019
• Source: Schulthess Klinik
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: December 19, 2018
• Est. primary completion date: December 19, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis - Hand Joint

Intervention

Procedure:
• silicone metacarpophalangeal arthroplasty (SMPA)
Replacement of the metacarpophalangeal (MCP) joint using a silicone arthroplasty

Locations

Country	Name	City	State
Switzerland	Schulthess Klinik	Zurich

Sponsors (1)

Lead Sponsor	Collaborator
Schulthess Klinik

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Satisfaction with the treatment result assessed on a 5-point Likert Scale	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).	at least one year after surgery