N/A
N=21
Influence of Custom Orthosis Post Carpometacarpal (CMC) Arthroplasty
Thumb Osteoarthritis
Bottom Line
View on ClinicalTrials.gov: NCT05307510 ↗Enrolled (actual)
21
Serious AEs
0.0%
Results posted
Oct 2024
Primary outcome: Primary: Change in Pain Post-operatively Using the Visual Analog Scale (Pain VAS) — 2.5; 4.2; 5.3; 5.8 score on a scale — p=0.135
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Prefabricated splint (Device); Custom Orthosis (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Toledo
- Primary completion
- Oct 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Pain Post-operatively Using the Visual Analog Scale (Pain VAS) |
2.5; 4.2; 5.3; 5.8; 5; 6 | 0.135 |
| PRIMARY Change in Wound Dehiscence Post-operatively as Measured by Sandy Grading System |
1; 1 | 1 |
| SECONDARY Change in the Amount of Thumb CMC Active Range of Motion Post-operatively |
37.50; 41; 39.5; 42.6 | .635 |
| SECONDARY Change in Client's Self-report of Hand Function Post-operatively as Measured by the QuickDash Disabilities of Arm, Shoulder, and Hand (QuickDASH) |
48; 40.6 | .495 |
| SECONDARY Change in the Degree of Dexterity Post-operatively as Measured by the Applied Dexterity Portion of the Arthritis Hand Function Test |
.36; .36; 1.37; 1.35; .31; .33 | .953 |
Summary
This study aims to compare post-surgical outcomes of individuals who receive either a custom orthosis or prefabricated splint after carpometacarpal arthroplasty.
Eligibility Criteria
Inclusion Criteria
- status post CMC arthroplasty
- 18 or older
- able to read and understand English
- capable of independently consenting to health care procedures.
Exclusion Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT05307510). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.