Silicone Arthroplasty vs. Arthrodesis in the Distal Interphalangeal Joint

NCT ID: NCT01740999

Last Updated: 2016-04-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

49 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-06-30

Study Completion Date

2015-12-31

Brief Summary

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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

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Conditions

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Finger Joint Arthroplasty Replacement

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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silicone arthroplasty

silicone arthroplasty

Group Type EXPERIMENTAL

silicone arthroplasty

Intervention Type PROCEDURE

silicone arthroplasty

arthrodesis

arthrodesis

Group Type ACTIVE_COMPARATOR

arthrodesis

Intervention Type PROCEDURE

arthrodesis

Interventions

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silicone arthroplasty

silicone arthroplasty

Intervention Type PROCEDURE

arthrodesis

arthrodesis

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Schulthess Klinik

OTHER

Sponsor Role lead

Responsible Party

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Sebastian Kluge

Dr. med.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Schulthess Klinik

Zurich, , Switzerland

Site Status

Countries

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Switzerland

Other Identifiers

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DIP_01

Identifier Type: -

Identifier Source: org_study_id

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