Custom Orthosis for Osteoarthritis of the Thumb

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Osteoarthritis of the ThumbCustom Orthosis - Device
Eligibility
18+
All Sexes
What conditions do you have?
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Study Summary

This trial will compare how well two types of hand surgery help patients who have arthritis in their thumb.

Eligible Conditions
  • Osteoarthritis of the Thumb

Treatment Effectiveness

Study Objectives

2 Primary · 3 Secondary · Reporting Duration: baseline (~10days after surgery), 5-6 week after surgery, 11-12 weeks after surgery

Week 12
Change in client's self-report of hand function post-operatively as measured by the QuickDASH
Change in the amount of thumb CMC active range of motion post-operatively
Change in the degree of dexterity post-operatively as measured by the applied dexterity portion of the Arthritis Hand Function Test
Week 12
Patient satisfaction with device and services as measured by Orthotics and Prosthetics User's Survey (OPUS) Satisfaction with Device and Services
Week 12
Change in Pain post-operatively using the Visual Analog Scale (Pain VAS)
Change in Wound Dehiscence post-operatively as measured by Sandy Grading System
Change in presence of edema post-operatively as measured by a circumferential measurement

Trial Safety

Trial Design

2 Treatment Groups

Intervention A - prefabricated splint
1 of 2
Intervention B - custom orthosis
1 of 2

Active Control

Experimental Treatment

125 Total Participants · 2 Treatment Groups

Primary Treatment: Custom Orthosis · No Placebo Group · N/A

Intervention B - custom orthosis
Device
Experimental Group · 1 Intervention: Custom Orthosis · Intervention Types: Device
Intervention A - prefabricated splint
Device
ActiveComparator Group · 1 Intervention: Prefabricated splint · Intervention Types: Device

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: baseline (~10days after surgery), 5-6 week after surgery, 11-12 weeks after surgery

Who is running the clinical trial?

University of ToledoLead Sponsor
5 Previous Clinical Trials
297 Total Patients Enrolled
Laura Schmelzer, PhDPrincipal InvestigatorThe University of Toledo

Eligibility Criteria

Age 18+ · All Participants · 4 Total Inclusion Criteria

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