Silicone Arthroplasty vs. Arthrodesis in the Distal Interphalangeal Joint

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

Status

Terminated

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01740999

Enrollment

Registered

2012-12-04

Start date

2012-06-30

Completion date

2015-12-31

Last updated

2016-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Arthroplasty, Finger Joint, Replacement

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.

Interventions

PROCEDUREsilicone arthroplasty

silicone arthroplasty

PROCEDUREarthrodesis

arthrodesis

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Michigan Hand Questionnaire (MHQ)	12 months postoperative	Comparison of silicone arthroplasty and arthrodesis in respect to MHQ

Secondary

Measure	Time frame
Change of Michigan Hand Questionnaire Score	preoperative, 3mo/6mo/36mo postoperative

Other

Measure	Time frame	Description
Change of objective clinical parameters	preoperative, 3mo/6mo/12mo/36mo postoperative	measurements of grip strength and range of motion

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026