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Oval-8 Splinting Versus Standardized Treatment With Tee Pee or Forearm Based Thumb Spica Splinting

NCT02266095 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2016-11-04

No results posted yet for this study

Summary

The oval-8 splint has been developed for many uses in finger pathology and trauma. It has not, however, been used to treat thumb carpometacarpal (CMC) joint arthritis. When treating thumb CMC joint osteoarthritis, splinting is a very widely used and supported treatment option for non-operative management. Many studies have been performed showing that thumb spica splinting in abduction with either a hand based or forearm based splint improves pain. This study aims to compare the effects of a novel splinting approach with oval-8 splints for the hyperextended thumb interphalangeal (IP) joint vs. standardized treatment with Tee Pee splinting (hand based thumb spica) or forearm thumb spica splinting on pain and function of patients with thumb CMC joint arthritis.

This is a pilot study will address the following hypothesis: Splinting of the hyperextended thumb IP joint with oval-8 splints will lead to increased DASH scores and decreased pain on physical exam compared to splinting with thumb spica splints in patients with thumb CMC arthritis.

Conditions

  • Carpometacarpal (CMC) Joint Arthritis

Interventions

DEVICE

Oval-8 Splint

Splinting with Oval-8

DEVICE

Tee Pee Splint

Splinting with Tee Pee

DEVICE

Forearm Based Splint

Splinting with Forearm based

Sponsors & Collaborators

  • University of Florida

    lead OTHER

Principal Investigators

  • Marc B Kaye, M.D. · University of Florida

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-01-31
Primary Completion
2016-08-31
Completion
2016-08-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02266095 on ClinicalTrials.gov