Silicone Arthroplasty vs. Arthrodesis in the Distal Interphalangeal Joint

NCT01740999 — Not applicable, Terminated, 49 participants, Schulthess Klinik
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Functional Outcome in Silicone Arthroplasty Compared to Arthrodesis Screws in Patients With Osteoarthritis in the Distal Interphalangeal Joint

RegistryNCT01740999
StatusTerminated - Non achievement of the estimated sample size of the group silicone arthroplasty in a reasonable recruitment time.
PhaseNot applicable
Study typeInterventional; non randomized, parallel, masking: none, treatment
Enrollment49 (Actual)
SponsorSchulthess Klinik (Other)
ConditionsFinger Joint, Arthroplasty, Replacement
Interventionssilicone arthroplasty, arthrodesis (Procedure)
Datesstart 2012-06-01, primary completion 2015-12-01, completion 2015-12-01, first posted 2012-12-04, last updated 2016-04-18
Locations1 site in Switzerland

Related Papers Related Patents Related Grants Related Experts
All trials for Finger Joint All trials for Arthroplasty All trials of silicone arthroplasty All trials of arthrodesis

-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.

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+Arms and interventions

ArmTypeInterventionsDescription
silicone arthroplastyExperimentalProcedure: silicone arthroplastysilicone arthroplasty
arthrodesisActive comparatorProcedure: arthrodesisarthrodesis
  • silicone arthroplasty (Procedure): silicone arthroplasty
  • arthrodesis (Procedure): arthrodesis

+Outcome measures

Primary outcomes

  • Michigan Hand Questionnaire (MHQ) [12 months postoperative]: Comparison of silicone arthroplasty and arthrodesis in respect to MHQ

Secondary outcomes

  • Change of Michigan Hand Questionnaire Score [preoperative, 3mo/6mo/36mo postoperative]

Other outcomes

  • Change of objective clinical parameters [preoperative, 3mo/6mo/12mo/36mo postoperative]: measurements of grip strength and range of motion

+Eligibility

Sex: All, ages: 18 Years to any

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

+Locations (1)

FacilityCityCountryStatus
Schulthess KlinikZurichSwitzerland