Patient Satisfaction After Silicone Metacarpophalangeal Arthroplasty

NCT03626116 | Completed

• 1 other identifier: MCP Arthroplasty RA patients
• Study Type: observational
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

Rheumatoid Arthritis - Hand Joint

Outcome Measures

Primary Outcomes (1)

• 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

Interventions

silicone metacarpophalangeal arthroplasty (SMPA) PROCEDURE

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with RA / Psoriasisarthritis / Lupus erythomatodes who had a SMPA

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Schulthess Klinik: lead

Study Sites (1)

Schulthess Klinik

Zurich, 8008, Switzerland

Location

Study Officials

• Stephan Schindele, MD

  Schulthess Klinik

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 19, 2018
• First Posted: August 10, 2018
• Study Start: July 18, 2018
• Primary Completion: December 19, 2018
• Study Completion: December 19, 2018
• Last Updated: April 5, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)