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OpenTrials
Completed

NCT Number: NCT03074916

Outcomes of Motion-preserving Surgery and Arthrodesis at the Distal Interphalangeal (DIP) Joint

The objective of this project is to investigate the subjective and clinical outcome in patients at least one year after DIP arthroplasty and compare them to matched patients with an arthrodesis.

The primary endpoint is the satisfaction with the treatment result of in the motion-preserving DIP surgery at follow-up.

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Key information

Conditions

Distal Interphalangeal Arthroplasty Distal Interphalangeal Arthrodesis

Age range

18 year–111 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Schulthess Klinik

Zurich, 8008, Switzerland

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Arthroplasty group:

  • DIP silicone arthroplasty at least one year ago
  • Informed consent as documented by signature

Arthrodesis group:

  • Matched patients with an DIP arthrodesis
  • Informed consent as documented by signature

Exclusion criteria

Arthroplasty group:

  • Silicone arthroplasty at the thumb IP joint
  • Major surgery at another joint (PIP arthroplasty, thumb trapeziectomy) less than 6 months ago
  • Legal incompetence
  • German language barrier to complete the questionnaires

Arthrodesis group:

  • Arthroplasty at another DIP joint
  • Major surgery at another joint (PIP arthroplasty, thumb trapeziectomy) less than 6 months ago
  • Legal incompetence
  • German language barrier to complete the questionnaires

Treatment and study plan

DIP arthroplasty or arthrodesis

Device

Arthroplasty of the DIP Joint or arthrodesis of the DIP joint

Primary outcomes

  1. satisfaction with the treatment result of the motion-preserving DIP surgery at follow-up

    Time frame: at least 1 year up to 7 years

    Question to be answered on a 5 Point Likert scale

Secondary outcomes

  1. Michigan Hand Questionnaire

    Time frame: at least 1 year up to 7 years

    Questionnaire about Hand function scored 0-100

Sponsors and collaborators

Lead sponsor

Schulthess Klinik

Other

Registry information

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Mar 9, 2017
Registry last updated
Apr 26, 2018

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.