Clinical trial NCT05307510: Influence of Custom Orthosis Post Carpometacarpal (CMC) Arthroplasty
Official title: Influence of Custom Orthosis Post Carpometacarpal CMC) Arthroplasty
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Thumb Osteoarthritis
Keywords: Carpometacarpal
Thumb
Arthroplasty
Splints
Function
Lead sponsor: University of Toledo
Sponsor class: OTHER
First posted: 2022-04-01
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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.

Primary outcomes:
measure: Change in Pain Post-operatively Using the Visual Analog Scale (Pain VAS)
timeFrame: 11-12 weeks after surgery
measure: Change in Wound Dehiscence Post-operatively as Measured by Sandy Grading System
timeFrame: 11-12 weeks after surgery
Secondary outcomes:
measure: Change in the Amount of Thumb CMC Active Range of Motion Post-operatively
timeFrame: 11-12 weeks after surgery
measure: Change in Client's Self-report of Hand Function Post-operatively as Measured by the QuickDash Disabilities of Arm, Shoulder, and Hand (QuickDASH)
timeFrame: 11-12 weeks after surgery
measure: Change in the Degree of Dexterity Post-operatively as Measured by the Applied Dexterity Portion of the Arthritis Hand Function Test
timeFrame: 11-12 weeks after surgery
Other outcomes:
measure: Patient Satisfaction With Device and Services as Measured by Orthotics and Prosthetics User's Survey (OPUS) Satisfaction With Device and Services
timeFrame: 11-12 weeks after surgery
measure: Change in Presence of Edema Post-operatively as Measured by a Circumferential Measurement
timeFrame: baseline (~10days after surgery), 5-6 week after surgery, 11-12 weeks after surgery
Locations:
city: Toledo
country: United States
facility: University of Toledo Medical Center
state: Ohio
Study officials:
affiliation: The University of Toledo
name: Laura Schmelzer, PhD
role: PRINCIPAL_INVESTIGATOR
References: