Thumb OsteoarthritisNCT05307510
Influence of Custom Orthosis Post Carpometacarpal (CMC) Arthroplasty
A study testing Prefabricated splint and Custom Orthosis in people with Thumb Osteoarthritis, run by University of Toledo at 1 site in United States.
Trial summary
This study aims to compare post-surgical outcomes of individuals who receive either a custom orthosis or prefabricated splint after carpometacarpal arthroplasty. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Thumb Osteoarthritis
- What is being tested?
- Prefabricated splint and Custom Orthosis
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Apr 2022to 27 Oct 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- status post CMC arthroplasty
- 18 or older
- able to read and understand English
- capable of independently consenting to health care procedures.
Who cannot join
- if the surgeon identifies risk factors that would preclude random assignment to the control or experimental group
- if subject requests a prefabricated or custom orthosis.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Toledo Medical Center
Toledo, Ohio, 43606
About this study
Official title: Influence of Custom Orthosis Post Carpometacarpal CMC) Arthroplasty
This study aims to compare post-surgical outcomes of individuals who receive either a custom orthosis or prefabricated splint after carpometacarpal arthroplasty.
Read the detailed description
This research study will randomly assign subjects post CMC arthroplasty to Intervention A (prefabricated splint) or Intervention B (custom orthosis). The orthosis and splint being used in this study are both considered standard practice. Subjects will be provided the splint or orthosis at the first post-operative appointment. Subjects who are assigned to Intervention A will be provided a pre-fabricated splint by a member of the surgical team. Subjects who are assigned to Invention B will be evaluated by an occupational therapist and a custom orthosis will be fabricated. Outcome measures include: QuickDASH, Pain Visual Analogue Scale, active range of motion measurements, the Applied Dexterity portion of the Arthritis Hand Function Test except for the putty cutting task, edema, Sandy Grading Score and the Orthotics and Prosthetics User's Survey (OPUS) Satisfaction with Device and Services. Data will be collected at the first, second, and third post-operative appointment.
- Conditions
- Thumb Osteoarthritis
- Being tested
- Prefabricated splint, Custom Orthosis
- Keywords
- Carpometacarpal, Thumb, Arthroplasty, Splints, Function
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prefabricated splintDevice
Subjects will be provided either a prefabricated splint
Custom OrthosisDevice
Subjects will be evaluated by an occupational therapist who will fabricate a custom orthosis.
| Study group | Role | What they receive |
|---|---|---|
| Intervention A - prefabricated splint | Active comparator | A prefabricated splint is provided to the client Receives: Device: Prefabricated splint |
| Intervention B - custom orthosis | Experimental | a custom orthosis (wrist splint with thumb spica) is fabricated by an occupational therapist Receives: Device: Custom Orthosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Pain Post-operatively Using the Visual Analog Scale (Pain VAS)
The Pain Visual Analog Scale is a self-report measure of pain with a range of 0= no pain - 10 = worst pain. Subjects report pain while using hand.
Measured: 11-12 weeks after surgery
Change in Wound Dehiscence Post-operatively as Measured by Sandy Grading System
Sandy Grading System is a scale used to measure wound dehiscence. Scale contains 6 grades (I, Ia, II, Ia, III, IIIa). A grade of I indicates no clinical signs of microbiological confirmation of infection and IIIa indicates presence of clinical signs and confirmed microbiological confirmation of infection. The higher number indicates increased presence of infection.
Measured: 11-12 weeks after surgery
Secondary outcomes (3)
Change in the Amount of Thumb CMC Active Range of Motion Post-operatively
Goniometric measurements for active radial and palmar abduction will determine the amount of active movement. More range indicates better movement (0-50 = radial abduction norms) (0-70 = palmar abduction norms)
Measured: 11-12 weeks after surgery
Change in Client's Self-report of Hand Function Post-operatively as Measured by the QuickDash Disabilities of Arm, Shoulder, and Hand (QuickDASH)
The QuickDash is a questionnaire about symptoms and ability to perform certain activities. Scores range from 0 (no disability) to 100 (severe disability).
Measured: 11-12 weeks after surgery
Change in the Degree of Dexterity Post-operatively as Measured by the Applied Dexterity Portion of the Arthritis Hand Function Test
Four of Five items (fasten and unfasten buttons, lace a shoe and tie a bow, pin and unpin two safety pins in a cloth, pick up and manipulate four coins into a slot) will be completed. Each task will be timed. A shorter amount of time indicates better dexterity.
Measured: 11-12 weeks after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2022
- Study start21 Apr 2022
- Primary completion27 Oct 2023
- Study completion27 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Thumb OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Toledo
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Laura Schmelzer, PhD, Principal investigator, The University of Toledo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05307510
- Sponsor's protocol ID
- UToledo301275
- Status last verified
- Sep 2024
- First submitted
- 1 Mar 2022
- Last updated
- 8 Oct 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Custom Orthosis Post Carpometacarpal CMC) Arthroplasty
- ClinicalTrials.gov ID
- NCT05307510
- Acronym / sponsor ID
- UToledo301275
- Conditions
- Thumb Osteoarthritis
- Keywords
- Carpometacarpal, Thumb, Arthroplasty, Splints, Function
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- University of ToledoUniversity, hospital or other
- Study start
- 21 Apr 2022 (actual)
- Primary completion
- 27 Oct 2023 (actual)
- Study completion
- 27 Oct 2023 (actual)
- First posted
- 1 Apr 2022 (actual)
- Results
- Posted 8 Oct 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to compare post-surgical outcomes of individuals who receive either a custom orthosis or prefabricated splint after carpometacarpal arthroplasty.
Detailed description
This research study will randomly assign subjects post CMC arthroplasty to Intervention A (prefabricated splint) or Intervention B (custom orthosis). The orthosis and splint being used in this study are both considered standard practice. Subjects will be provided the splint or orthosis at the first post-operative appointment. Subjects who are assigned to Intervention A will be provided a pre-fabricated splint by a member of the surgical team. Subjects who are assigned to Invention B will be evaluated by an occupational therapist and a custom orthosis will be fabricated. Outcome measures include: QuickDASH, Pain Visual Analogue Scale, active range of motion measurements, the Applied Dexterity portion of the Arthritis Hand Function Test except for the putty cutting task, edema, Sandy Grading Score and the Orthotics and Prosthetics User's Survey (OPUS) Satisfaction with Device and Services. Data will be collected at the first, second, and third post-operative appointment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention A - prefabricated splint | Active comparator | Device: Prefabricated splintA prefabricated splint is provided to the client |
| Intervention B - custom orthosis | Experimental | Device: Custom Orthosisa custom orthosis (wrist splint with thumb spica) is fabricated by an occupational therapist |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- status post CMC arthroplasty
- 18 or older
- able to read and understand English
- capable of independently consenting to health care procedures.
Key exclusion criteria (2 listed)
- if the surgeon identifies risk factors that would preclude random assignment to the control or experimental group
- if subject requests a prefabricated or custom orthosis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prefabricated splintSubjects will be provided either a prefabricated splint | Device | Intervention A - prefabricated splint |
| Custom OrthosisSubjects will be evaluated by an occupational therapist who will fabricate a custom orthosis. | Device | Intervention B - custom orthosis |
Primary outcome
Change in Pain Post-operatively Using the Visual Analog Scale (Pain VAS)
Time frame: 11-12 weeks after surgery
The Pain Visual Analog Scale is a self-report measure of pain with a range of 0= no pain - 10 = worst pain. Subjects report pain while using hand.
Change in Wound Dehiscence Post-operatively as Measured by Sandy Grading System
Time frame: 11-12 weeks after surgery
Sandy Grading System is a scale used to measure wound dehiscence. Scale contains 6 grades (I, Ia, II, Ia, III, IIIa). A grade of I indicates no clinical signs of microbiological confirmation of infection and IIIa indicates presence of clinical signs and confirmed microbiological confirmation of infection. The higher number indicates increased presence of infection.
3 secondary outcomes
Change in the Amount of Thumb CMC Active Range of Motion Post-operatively
Time frame: 11-12 weeks after surgery
Change in Client's Self-report of Hand Function Post-operatively as Measured by the QuickDash Disabilities of Arm, Shoulder, and Hand (QuickDASH)
Time frame: 11-12 weeks after surgery
Change in the Degree of Dexterity Post-operatively as Measured by the Applied Dexterity Portion of the Arthritis Hand Function Test
Time frame: 11-12 weeks after surgery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Thumb Osteoarthritis
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Surgery for Thumb Base Osteoarthritis: Joint Replacement vs. Trapeziectomy
Thumb Osteoarthritis, Thumb Carpometacarpal Joint Osteoarthritis
Not yet recruitingObservational study
Thumb Muscle Activation During Different Activities of Daily Living in Thumb Base Osteoarthritis and Healthy Controls
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Laura Schmelzer, PhD principal investigator
The University of Toledo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prefabricated splint and Custom Orthosis in people with Thumb Osteoarthritis, run by University of Toledo at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Oct 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Pain Post-operatively Using the Visual Analog Scale (Pain VAS) (time frame: 11-12 weeks after surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2024.