Silicone Arthroplasty vs. Arthrodesis in the Distal Interphalangeal Joint

Not Applicable

Terminated

• Conditions: Replacement; Finger Joint; Arthroplasty
• Interventions: Procedure: silicone arthroplasty; Procedure: arthrodesis

• Registration Number: NCT01740999
• Lead Sponsor: Schulthess Klinik

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-06
• Study First Submitted: 2012-11-27
• Study First Submitted QC: 2012-11-30
• Study First Posted: 2012-12-04
• Primary Completion: 2015-12
• Study Completion: 2015-12
• Status Verified: 2016-04
• Last Update Submitted: 2016-04-15
• Last Update Posted: 2016-04-18

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 49

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
silicone arthroplasty	silicone arthroplasty	silicone arthroplasty
arthrodesis	arthrodesis	arthrodesis

Primary Outcome Measures

Name	Time	Method
Michigan Hand Questionnaire (MHQ)	12 months postoperative	Comparison of silicone arthroplasty and arthrodesis in respect to MHQ

Secondary Outcome Measures

Name	Time	Method
Change of Michigan Hand Questionnaire Score	preoperative, 3mo/6mo/36mo postoperative

Trial Locations

Locations (1)

Schulthess Klinik; 🇨🇭 Zürich, Switzerland