Patient Satisfaction After Silicone Metacarpophalangeal Arthroplasty
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|ClinicalTrials.gov Identifier: NCT03626116|
Recruitment Status : Completed
First Posted : August 10, 2018
Last Update Posted : April 5, 2019
|Condition or disease||Intervention/treatment|
|Rheumatoid Arthritis - Hand Joint||Procedure: silicone metacarpophalangeal arthroplasty (SMPA)|
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 Type :||Observational|
|Actual Enrollment :||42 participants|
|Official Title:||What Determines Satisfaction of Patients With Rheumatoid Arthritis After Hand Reconstruction Using Silicone Metacarpophalangeal Arthroplasty|
|Actual Study Start Date :||July 18, 2018|
|Actual Primary Completion Date :||December 19, 2018|
|Actual Study Completion Date :||December 19, 2018|
- Procedure: silicone metacarpophalangeal arthroplasty (SMPA)
Replacement of the metacarpophalangeal (MCP) joint using a silicone arthroplasty
- 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).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03626116
|Zurich, Switzerland, 8008|
|Principal Investigator:||Stephan Schindele, MD||Schulthess Klinik|