Ignite Creation Date:
2025-12-24 @ 1:13 PM
Ignite Modification Date:
2026-02-20 @ 6:43 PM
Study NCT ID:
NCT02266095
Status:
WITHDRAWN
Last Update Posted:
2016-11-04
First Post:
2014-10-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Oval-8 Splinting Versus Standardized Treatment With Tee Pee or Forearm Based Thumb Spica Splinting
Sponsor:
University of Florida
Organization:
Study Overview
Official Title:
Pilot Study of a Novel Splint Treatment for Thumb CMC Joint Arthritis: a Comparison of Oval-8 Splinting Versus Standardized Treatment With Tee Pee or Forearm Based Thumb Spica Splinting
Status:
WITHDRAWN
Status Verified Date:
2015-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Study closed prior to enrolling patients
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Oval-8
Brief 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.
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.
Detailed Description:
After informed consent is obtained and the patient has met all of the inclusion criteria and non of the exclusion criteria, the patient will be assigned a study ID number. The patient will be randomized with a ratio of 1:1:1 to a splint treatment with either a forearm thumb spica splint, Tee-Pee splint or oval- 8 splint at the time of initial visit to Orthopaedic Hand clinic (week 1 visit). The patient will be fitted and provided with the appropriate splint by Orthopaedic physician.
Baseline radiographs (3 views anterior-posterior, lateral and oblique) and data points will be gathered from initial clinic history and physical, as performed per normal clinical protocol: arthritis grade, hand involved, dominant hand, interphalangeal (IP) extension, MCP extension, pinch strength, grip strength, pain scale, location of pain, DASH scores, analgesic use, and work/hobby activity. Additionally, demographic data including age, gender and race/ethnicity will be gathered and patient will be asked to repeat pinch and grip tests with study splint applied and asked to repeat assessment of pain scale.
Baseline radiographs (3 views anterior-posterior, lateral and oblique) and data points will be gathered from initial clinic history and physical, as performed per normal clinical protocol: arthritis grade, hand involved, dominant hand, interphalangeal (IP) extension, MCP extension, pinch strength, grip strength, pain scale, location of pain, DASH scores, analgesic use, and work/hobby activity. Additionally, demographic data including age, gender and race/ethnicity will be gathered and patient will be asked to repeat pinch and grip tests with study splint applied and asked to repeat assessment of pain scale.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: