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Completed

NCT Number: NCT03626116

Patient Satisfaction After Silicone Metacarpophalangeal Arthroplasty

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.

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Key information

Conditions

Rheumatoid Arthritis - Hand Joint

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Schulthess Klinik

Zurich, 8008, Switzerland

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

silicone metacarpophalangeal arthroplasty (SMPA)

Procedure

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

Primary outcomes

  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).

Sponsors and collaborators

Lead sponsor

Schulthess Klinik

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Aug 10, 2018
Registry last updated
Apr 5, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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