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Splints for Thumb Osteoarthritis
N/A
Waitlist Available
Led By Laura Schmelzer, PhD
Research Sponsored by University of Toledo
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline (~10days after surgery), 5-6 week after surgery, 11-12 weeks after surgery
Awards & highlights
Study Summary
This trial will compare how well two types of hand surgery help patients who have arthritis in their thumb.
Who is the study for?
This trial is for English-speaking adults over 18 who have had carpometacarpal arthroplasty, a hand surgery. They must be able to consent to health care procedures on their own. People can't join if the surgeon sees risks that prevent them from being randomly assigned to a study group or if they request a specific type of orthosis.Check my eligibility
What is being tested?
The study compares two types of hand supports after thumb joint surgery: one group gets a custom-made orthosis and the other receives a standard prefabricated splint. The goal is to see which support offers better post-surgical outcomes.See study design
What are the potential side effects?
While not explicitly stated, potential side effects may include discomfort, reduced mobility, skin irritation, or allergic reactions related to wearing either the custom orthosis or prefabricated splint.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline (~10days after surgery), 5-6 week after surgery, 11-12 weeks after surgery
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline (~10days after surgery), 5-6 week after surgery, 11-12 weeks after surgery
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in Pain post-operatively using the Visual Analog Scale (Pain VAS)
Change in Wound Dehiscence post-operatively as measured by Sandy Grading System
Secondary outcome measures
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
Other outcome measures
Change in presence of edema post-operatively as measured by a circumferential measurement
Patient satisfaction with device and services as measured by Orthotics and Prosthetics User's Survey (OPUS) Satisfaction with Device and Services
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Intervention B - custom orthosisExperimental Treatment1 Intervention
a custom orthosis (wrist splint with thumb spica) is fabricated by an occupational therapist
Group II: Intervention A - prefabricated splintActive Control1 Intervention
A prefabricated splint is provided to the client
Find a Location
Who is running the clinical trial?
University of ToledoLead Sponsor
7 Previous Clinical Trials
617 Total Patients Enrolled
Laura Schmelzer, PhDPrincipal InvestigatorThe University of Toledo
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have had joint replacement surgery in the past.You will not be included if you ask for a pre-made or customized brace or support.
Research Study Groups:
This trial has the following groups:- Group 1: Intervention A - prefabricated splint
- Group 2: Intervention B - custom orthosis
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are any new participants being accepted in this research project?
"Affirmative. According to the information provided on clinicaltrials.gov, this medical investigation is still open for participant enrollment. It was initially announced on April 21st 2022 and has been recently revised on November 2nd 2022. The study necessitates 125 participants from a single site."
Answered by AI
What is the capacity of individuals who may be enrolled in this trial?
"Affirmative, the details listed on clinicaltrials.gov indicate that this investigation is now recruiting participants. The trial was first issued on April 21st 2022 and has been modified for the last time on November 2nd 2022. Currently, 125 patients are being sought from 1 site."
Answered by AI
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