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Patient Satisfaction After Silicone Metacarpophalangeal Arthroplasty

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date July 19, 2018
First Posted Date August 10, 2018
Last Update Posted Date April 5, 2019
Actual Study Start Date July 18, 2018
Actual Primary Completion Date December 19, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: August 7, 2018)
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).
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Patient Satisfaction After Silicone Metacarpophalangeal Arthroplasty
Official Title What Determines Satisfaction of Patients With Rheumatoid Arthritis After Hand Reconstruction Using Silicone Metacarpophalangeal Arthroplasty
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 Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients with RA / Psoriasisarthritis / Lupus erythomatodes who had a SMPA
Condition Rheumatoid Arthritis - Hand Joint
Intervention Procedure: silicone metacarpophalangeal arthroplasty (SMPA)
Replacement of the metacarpophalangeal (MCP) joint using a silicone arthroplasty
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: April 3, 2019)
42
Original Estimated Enrollment
 (submitted: August 7, 2018)
50
Actual Study Completion Date December 19, 2018
Actual Primary Completion Date December 19, 2018   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Switzerland
Removed Location Countries  
 
Administrative Information
NCT Number NCT03626116
Other Study ID Numbers MCP Arthroplasty RA patients
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Schulthess Klinik
Study Sponsor Schulthess Klinik
Collaborators Not Provided
Investigators
Principal Investigator: Stephan Schindele, MD Schulthess Klinik
PRS Account Schulthess Klinik
Verification Date April 2019