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Silicone Arthroplasty vs. Arthrodesis in the Distal Interphalangeal Joint

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ClinicalTrials.gov Identifier: NCT01740999
Recruitment Status : Terminated (Non achievement of the estimated sample size of the group silicone arthroplasty in a reasonable recruitment time.)
First Posted : December 4, 2012
Last Update Posted : April 18, 2016
Sponsor:
Information provided by (Responsible Party):
Sebastian Kluge, 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.


Condition or disease Intervention/treatment Phase
Finger Joint Arthroplasty Replacement Procedure: silicone arthroplasty Procedure: arthrodesis Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 49 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Functional Outcome in Silicone Arthroplasty Compared to Arthrodesis Screws in Patients With Osteoarthritis in the Distal Interphalangeal Joint
Study Start Date : June 2012
Actual Primary Completion Date : December 2015
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: silicone arthroplasty
silicone arthroplasty
Procedure: silicone arthroplasty
silicone arthroplasty

Active Comparator: arthrodesis
arthrodesis
Procedure: arthrodesis
arthrodesis




Primary Outcome Measures :
  1. Michigan Hand Questionnaire (MHQ) [ Time Frame: 12 months postoperative ]
    Comparison of silicone arthroplasty and arthrodesis in respect to MHQ


Secondary Outcome Measures :
  1. Change of Michigan Hand Questionnaire Score [ Time Frame: preoperative, 3mo/6mo/36mo postoperative ]

Other Outcome Measures:
  1. Change of objective clinical parameters [ Time Frame: preoperative, 3mo/6mo/12mo/36mo postoperative ]
    measurements of grip strength and range of motion



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01740999


Locations
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Switzerland
Schulthess Klinik
Zürich, Switzerland, 8008
Sponsors and Collaborators
Schulthess Klinik

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Responsible Party: Sebastian Kluge, Dr. med., Schulthess Klinik
ClinicalTrials.gov Identifier: NCT01740999     History of Changes
Other Study ID Numbers: DIP_01
First Posted: December 4, 2012    Key Record Dates
Last Update Posted: April 18, 2016
Last Verified: April 2016