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

Completed

• Conditions: Distal Interphalangeal Arthrodesis; Distal Interphalangeal Arthroplasty
• Interventions: Device: DIP arthroplasty or arthrodesis

• Registration Number: NCT03074916
• Lead Sponsor: Schulthess Klinik

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-02-23
• Study Start: 2017-03-08
• Study First Submitted QC: 2017-03-08
• Study First Posted: 2017-03-09
• Status Verified: 2018-04
• Primary Completion: 2018-04-18
• Study Completion: 2018-04-18
• Last Update Submitted: 2018-04-25
• Last Update Posted: 2018-04-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 52

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
DIP arthroplasty	DIP arthroplasty or arthrodesis	-
DIP arthrodesis	DIP arthroplasty or arthrodesis	-

Primary Outcome Measures

Name	Time	Method
satisfaction with the treatment result of the motion-preserving DIP surgery at follow-up	at least 1 year up to 7 years	Question to be answered on a 5 Point Likert scale

Secondary Outcome Measures

Name	Time	Method
Michigan Hand Questionnaire	at least 1 year up to 7 years	Questionnaire about Hand function scored 0-100

Trial Locations

Locations (1)

Schulthess Klinik; 🇨🇭 Zurich, Switzerland