NCT01740999

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
49

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2012

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

November 27, 2012

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 4, 2012

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

April 18, 2016

Status Verified

April 1, 2016

Enrollment Period

3.5 years

First QC Date

November 27, 2012

Last Update Submit

April 15, 2016

Conditions

Finger JointArthroplastyReplacement

Outcome Measures

Primary Outcomes (1)

  • Michigan Hand Questionnaire (MHQ)

    Comparison of silicone arthroplasty and arthrodesis in respect to MHQ

    12 months postoperative

Secondary Outcomes (1)

  • Change of Michigan Hand Questionnaire Score

    preoperative, 3mo/6mo/36mo postoperative

Other Outcomes (1)

  • Change of objective clinical parameters

    preoperative, 3mo/6mo/12mo/36mo postoperative

Study Arms (2)

silicone arthroplasty

EXPERIMENTAL

silicone arthroplasty

Procedure: silicone arthroplasty

arthrodesis

ACTIVE COMPARATOR

arthrodesis

Procedure: arthrodesis

Interventions

silicone arthroplastyPROCEDURE

silicone arthroplasty

silicone arthroplasty
arthrodesisPROCEDURE

arthrodesis

arthrodesis

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • primary osteoarthritis in the distal interphalangeal joint
  • require surgical treatment
  • patient aged 18 years and over
  • signed written informed consent

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Schulthess Klinik

Zurich, 8008, Switzerland

Location

MeSH Terms

Interventions

Arthrodesis

Intervention Hierarchy (Ancestors)

Orthopedic ProceduresSurgical Procedures, Operative

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. med.

Study Record Dates

First Submitted

November 27, 2012

First Posted

December 4, 2012

Study Start

June 1, 2012

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

April 18, 2016

Record last verified: 2016-04

Locations

CH(1)