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

Distal Interphalangeal Arthrodesis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03074916
• Other study ID #: DIP_Silicone_retro
• Status: Completed
• First received: February 23, 2017
• Last updated: April 25, 2018
• Start date: March 8, 2017
• Est. completion date: April 18, 2018

Study information

• Verified date: April 2018
• Source: Schulthess Klinik
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: April 18, 2018
• Est. primary completion date: April 18, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 111 Years

Eligibility

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

Related Conditions & MeSH terms

• Distal Interphalangeal Arthrodesis
• Distal Interphalangeal Arthroplasty

Intervention

Device:
• DIP arthroplasty or arthrodesis
Arthroplasty of the DIP Joint or arthrodesis of the DIP joint

Locations

Country	Name	City	State
Switzerland	Schulthess Klinik	Zurich

Sponsors (1)

Lead Sponsor	Collaborator
Schulthess Klinik

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	satisfaction with the treatment result of the motion-preserving DIP surgery at follow-up	Question to be answered on a 5 Point Likert scale	at least 1 year up to 7 years
Secondary	Michigan Hand Questionnaire	Questionnaire about Hand function scored 0-100	at least 1 year up to 7 years