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NCT Number: NCT05307510

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.

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Key information

Conditions

Thumb Osteoarthritis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Toledo Medical Center

Toledo, Ohio, 43606, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Prefabricated splint

Device

Subjects will be provided either a prefabricated splint

Custom Orthosis

Device

Subjects will be evaluated by an occupational therapist who will fabricate a custom orthosis.

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. Change in the Amount of Thumb CMC Active Range of Motion Post-operatively

    Time frame: 11-12 weeks after surgery

    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)

  2. 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

    The QuickDash is a questionnaire about symptoms and ability to perform certain activities. Scores range from 0 (no disability) to 100 (severe disability).

  3. 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

    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.

Other outcomes

  1. Patient Satisfaction With Device and Services as Measured by Orthotics and Prosthetics User's Survey (OPUS) Satisfaction With Device and Services

    Time frame: 11-12 weeks after surgery

    A 21 item self-report questionnaire to measure satisfaction with device and services. Items 1-15 address services, items 16- 21 address device. Items are scored 0-4, with a higher score indicating higher satisfaction. Total score can range between 0-84.

  2. Change in Presence of Edema Post-operatively as Measured by a Circumferential Measurement

    Time frame: baseline (~10days after surgery), 5-6 week after surgery, 11-12 weeks after surgery

    A circumferential measurement at the base (metacarpal phalangeal joint) of the surgical thumb.

Sponsors and collaborators

Lead sponsor

University of Toledo

Other

Registry information

Official study title

Influence of Custom Orthosis Post Carpometacarpal CMC) Arthroplasty

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Apr 1, 2022
Registry last updated
Oct 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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