Clinical trial NCT02266095: Oval-8 Splinting Versus Standardized Treatment With Tee Pee or Forearm Based Thumb Spica Splinting
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
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Carpometacarpal (CMC) Joint Arthritis
Keywords: Osteoarthritis
Thumb spica splint
Oval-8 splint
Tee-Pee splint
Lead sponsor: University of Florida
Sponsor class: OTHER
First posted: 2014-10-16
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility criteria: Inclusion Criteria:

* Carpometacarpal (CMC) osteoarthritis
* greater than or equal to 35 degrees of passive thumb interphalangeal (IP) joint hyperextension on physical exam

Exclusion Criteria:

* History of hand surgery to affected hand
* Prior surgical treatment for thumb carpometacarpal (CMC) osteoarthritis.
* Patients with diagnosis of an autoimmune arthritis and post traumatic arthritis

Primary outcomes:
measure: DASH Score
timeFrame: 12 Weeks
Secondary outcomes:
measure: Pain Score
timeFrame: 12 Weeks
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: UF Health Orthopaedics - Jacksonville (Emerson)
state: Florida
Study officials:
affiliation: University of Florida
name: Marc B Kaye, M.D.
role: PRINCIPAL_INVESTIGATOR
References: