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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
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Rheumatoid Arthritis - Hand Joint Procedure: silicone metacarpophalangeal arthroplasty (SMPA)

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

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Study Type : Observational
Actual Enrollment : 42 participants
Observational Model: Case-Only
Time Perspective: Retrospective
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

Resource links provided by the National Library of Medicine



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


Primary Outcome Measures :
  1. 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).




Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with RA / Psoriasisarthritis / Lupus erythomatodes who had a SMPA
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

Information from the National Library of Medicine

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


Locations
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Switzerland
Schulthess Klinik
Zurich, Switzerland, 8008
Sponsors and Collaborators
Schulthess Klinik
Investigators
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Principal Investigator: Stephan Schindele, MD Schulthess Klinik

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Responsible Party: Schulthess Klinik
ClinicalTrials.gov Identifier: NCT03626116     History of Changes
Other Study ID Numbers: MCP Arthroplasty RA patients
First Posted: August 10, 2018    Key Record Dates
Last Update Posted: April 5, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases