Silicone Arthroplasty vs. Arthrodesis in the Distal Interphalangeal Joint

Arthroplasty Clinical Trial

Official title:

Functional Outcome in Silicone Arthroplasty Compared to Arthrodesis Screws in Patients With Osteoarthritis in the Distal Interphalangeal Joint

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01740999
• Other study ID #: DIP_01
• Status: Terminated
• Phase: N/A
• First received: November 27, 2012
• Last updated: April 15, 2016
• Start date: June 2012
• Est. completion date: December 2015

Study information

• Verified date: April 2016
• Source: Schulthess Klinik
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: kantonale Ethikkommission Zürich
• Study type: Interventional

Clinical Trial Summary

The operational and favored standard therapy for the treatment of osteoarthritis in the distal interphalangeal joint is the arthrodesis, in which a titanium screw is used. Arthrodesis shows in the most cases the complete reduction of osteoarthritis pain and low loss of function. But restrictions are reported in fine motor skills.

The operation with silicone arthroplasty is similar. As an implant, a silicone joint is used, which has been sufficiently tested at the metacarpophalangeal joint and interphalangeal joint. The advantage of arthroplasty is the function obtained in the distal interphalangeal joint and the resulting improved fine motor skills.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 49
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• primary osteoarthritis in the distal interphalangeal joint

• require surgical treatment

• patient aged 18 years and over

• signed written informed consent

Exclusion Criteria:

• posttraumatic osteoarthritis

• rheumatoid disease

• pregnant woman

• any disease process that would preclude accurate evaluation (e.g. neuromuscular, psychiatric or metabolic disorder)

• legal incompetence

• no knowledge of German

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arthroplasty
• Finger Joint
• Replacement

Intervention

Procedure:
• silicone arthroplasty
silicone arthroplasty
• arthrodesis
arthrodesis

Locations

Country	Name	City	State
Switzerland	Schulthess Klinik	Zürich

Sponsors (1)

Lead Sponsor	Collaborator
Schulthess Klinik

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change of objective clinical parameters	measurements of grip strength and range of motion	preoperative, 3mo/6mo/12mo/36mo postoperative	No
Primary	Michigan Hand Questionnaire (MHQ)	Comparison of silicone arthroplasty and arthrodesis in respect to MHQ	12 months postoperative	No
Secondary	Change of Michigan Hand Questionnaire Score		preoperative, 3mo/6mo/36mo postoperative	No