Thumb Osteoarthritis
Conditions
Keywords
Carpometacarpal, Thumb, Arthroplasty, Splints, Function
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.
Interventions
DEVICEPrefabricated splint
Subjects will be provided either a prefabricated splint
DEVICECustom Orthosis
Subjects will be evaluated by an occupational therapist who will fabricate a custom orthosis.
Sponsors
University of Toledo
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Pain Post-operatively Using the Visual Analog Scale (Pain VAS) | 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 | 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
| Measure | Time frame | Description |
|---|---|---|
| Change in the Degree of Dexterity Post-operatively as Measured by the Applied Dexterity Portion of the Arthritis Hand Function Test | 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. |
| Change in Client's Self-report of Hand Function Post-operatively as Measured by the QuickDash Disabilities of Arm, Shoulder, and Hand (QuickDASH) | 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). |
| Change in the Amount of Thumb CMC Active Range of Motion Post-operatively | 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) |
Other
| Measure | Time frame | Description |
|---|---|---|
| Patient Satisfaction With Device and Services as Measured by Orthotics and Prosthetics User's Survey (OPUS) Satisfaction With Device and Services | 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. |
| Change in Presence of Edema Post-operatively as Measured by a Circumferential Measurement | 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. |
Countries
United States
Participant flow
Recruitment details
Recruitment for participants began in April of 2022 and concluded in September of 2023.
Participants by arm
| Arm | Count |
|---|---|
| Intervention A - Prefabricated Splint A prefabricated splint is provided to the client
Prefabricated splint: Subjects will be provided either a prefabricated splint | 9 |
| Intervention B - Custom Orthosis a custom orthosis (wrist splint with thumb spica) is fabricated by an occupational therapist
Custom Orthosis: Subjects will be evaluated by an occupational therapist who will fabricate a custom orthosis. | 12 |
| Total | 21 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 3 | 6 |
| Overall Study | Withdrawal by Subject | 0 | 1 |
Baseline characteristics
| Characteristic | Intervention B - Custom Orthosis | Total | Intervention A - Prefabricated Splint |
|---|---|---|---|
| Age, Continuous | 61.42 years STANDARD_DEVIATION 8.93 | 62.86 years STANDARD_DEVIATION 8.39 | 64.78 years STANDARD_DEVIATION 7.68 |
| Race/Ethnicity, Customized African American | 1 Participants | 3 Participants | 2 Participants |
| Race/Ethnicity, Customized Caucasian | 11 Participants | 18 Participants | 7 Participants |
| Sandy Grading Scale Grade I | 12 Participants | 21 Participants | 9 Participants |
| Sandy Grading Scale other grades | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Female | 10 Participants | 16 Participants | 6 Participants |
| Sex: Female, Male Male | 2 Participants | 5 Participants | 3 Participants |
| VAS Pain Scale Pain at night | 5.42 units on a scale STANDARD_DEVIATION 2.94 | 5.19 units on a scale STANDARD_DEVIATION 3.25 | 4.89 units on a scale STANDARD_DEVIATION 3.88 |
| VAS Pain Scale Pain at rest | 4.17 units on a scale STANDARD_DEVIATION 2.76 | 4.14 units on a scale STANDARD_DEVIATION 2.72 | 4.11 units on a scale STANDARD_DEVIATION 2.93 |
| VAS Pain Scale Pain in use | 5.75 units on a scale STANDARD_DEVIATION 1.82 | 6.57 units on a scale STANDARD_DEVIATION 2.25 | 7.67 units on a scale STANDARD_DEVIATION 2.4 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 9 | 0 / 12 |
| other Total, other adverse events | 0 / 9 | 0 / 12 |
| serious Total, serious adverse events | 0 / 9 | 0 / 12 |
Outcome results
Primary
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.
Time frame: 11-12 weeks after surgery
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention A - Prefabricated Splint | Change in Pain Post-operatively Using the Visual Analog Scale (Pain VAS) | Pain in use | 5 score on a scale | Standard Deviation 2.76 |
| Intervention A - Prefabricated Splint | Change in Pain Post-operatively Using the Visual Analog Scale (Pain VAS) | Pain at rest | 2.5 score on a scale | Standard Deviation 2.1 |
| Intervention A - Prefabricated Splint | Change in Pain Post-operatively Using the Visual Analog Scale (Pain VAS) | Pain at night | 5.3 score on a scale | Standard Deviation 0.816 |
| Intervention B - Custom Orthosis | Change in Pain Post-operatively Using the Visual Analog Scale (Pain VAS) | Pain at rest | 4.2 score on a scale | Standard Deviation 1.3 |
| Intervention B - Custom Orthosis | Change in Pain Post-operatively Using the Visual Analog Scale (Pain VAS) | Pain at night | 5.8 score on a scale | Standard Deviation 2.6 |
| Intervention B - Custom Orthosis | Change in Pain Post-operatively Using the Visual Analog Scale (Pain VAS) | Pain in use | 6 score on a scale | Standard Deviation 1.9 |
Comparison: Pain at restp-value: 0.135t-test, 2 sided
Comparison: Pain at Nightp-value: 0.716t-test, 2 sided
Comparison: Pain in usep-value: 0.509t-test, 2 sided
Primary
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.
Time frame: 11-12 weeks after surgery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention A - Prefabricated Splint | Change in Wound Dehiscence Post-operatively as Measured by Sandy Grading System | 1 score on a scale | Standard Deviation 0 |
| Intervention B - Custom Orthosis | Change in Wound Dehiscence Post-operatively as Measured by Sandy Grading System | 1 score on a scale | Standard Deviation 0 |
p-value: 1t-test, 2 sided
Secondary
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).
Time frame: 11-12 weeks after surgery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention A - Prefabricated Splint | Change in Client's Self-report of Hand Function Post-operatively as Measured by the QuickDash Disabilities of Arm, Shoulder, and Hand (QuickDASH) | 48 score on a scale | Standard Deviation 15.6 |
| Intervention B - Custom Orthosis | Change in Client's Self-report of Hand Function Post-operatively as Measured by the QuickDash Disabilities of Arm, Shoulder, and Hand (QuickDASH) | 40.6 score on a scale | Standard Deviation 8.5 |
p-value: 0.49595% CI: [-16.16, 32]t-test, 2 sided
Secondary
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)
Time frame: 11-12 weeks after surgery
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention A - Prefabricated Splint | Change in the Amount of Thumb CMC Active Range of Motion Post-operatively | Palmar Abduction | 37.50 degrees | Standard Deviation 11.5 |
| Intervention A - Prefabricated Splint | Change in the Amount of Thumb CMC Active Range of Motion Post-operatively | Radial Abduction | 39.5 degrees | Standard Deviation 7.1 |
| Intervention B - Custom Orthosis | Change in the Amount of Thumb CMC Active Range of Motion Post-operatively | Palmar Abduction | 41 degrees | Standard Deviation 12 |
| Intervention B - Custom Orthosis | Change in the Amount of Thumb CMC Active Range of Motion Post-operatively | Radial Abduction | 42.6 degrees | Standard Deviation 8.3 |
Comparison: Palmar abduction of surgical handp-value: 0.635t-test, 2 sided
Comparison: Radial Abduction Surgical Handp-value: 0.52195% CI: [-13.6, 7.4]t-test, 2 sided
Secondary
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.
Time frame: 11-12 weeks after surgery
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention A - Prefabricated Splint | Change in the Degree of Dexterity Post-operatively as Measured by the Applied Dexterity Portion of the Arthritis Hand Function Test | Buttoning Buttons | .36 minutes | Standard Deviation 0.12 |
| Intervention A - Prefabricated Splint | Change in the Degree of Dexterity Post-operatively as Measured by the Applied Dexterity Portion of the Arthritis Hand Function Test | Lacing and tying a shoe | 1.37 minutes | Standard Deviation 0.22 |
| Intervention A - Prefabricated Splint | Change in the Degree of Dexterity Post-operatively as Measured by the Applied Dexterity Portion of the Arthritis Hand Function Test | Opening and closing safety pins | .31 minutes | Standard Deviation 0.13 |
| Intervention A - Prefabricated Splint | Change in the Degree of Dexterity Post-operatively as Measured by the Applied Dexterity Portion of the Arthritis Hand Function Test | Managing coins | .18 minutes | Standard Deviation 0.05 |
| Intervention B - Custom Orthosis | Change in the Degree of Dexterity Post-operatively as Measured by the Applied Dexterity Portion of the Arthritis Hand Function Test | Managing coins | .14 minutes | Standard Deviation 0.02 |
| Intervention B - Custom Orthosis | Change in the Degree of Dexterity Post-operatively as Measured by the Applied Dexterity Portion of the Arthritis Hand Function Test | Buttoning Buttons | .36 minutes | Standard Deviation 0.11 |
| Intervention B - Custom Orthosis | Change in the Degree of Dexterity Post-operatively as Measured by the Applied Dexterity Portion of the Arthritis Hand Function Test | Opening and closing safety pins | .33 minutes | Standard Deviation 0.05 |
| Intervention B - Custom Orthosis | Change in the Degree of Dexterity Post-operatively as Measured by the Applied Dexterity Portion of the Arthritis Hand Function Test | Lacing and tying a shoe | 1.35 minutes | Standard Deviation 0.35 |
Comparison: Buttoning Buttonsp-value: 0.953t-test, 2 sided
Comparison: Lacing and tying a shoep-value: 0.947t-test, 2 sided
Comparison: Opening and closing safety pinsp-value: 0.828t-test, 2 sided
Comparison: Managing coinsp-value: 0.169t-test, 2 sided
Other Pre-specified
Change in Presence of Edema Post-operatively as Measured by a Circumferential Measurement
A circumferential measurement at the base (metacarpal phalangeal joint) of the surgical thumb.
Time frame: baseline (~10days after surgery), 5-6 week after surgery, 11-12 weeks after surgery
Population: Insufficient data to report. Circumferential measurement at base of thumb did not capture distal edema. Consequently, surgical team did not collect this data.
Other Pre-specified
Patient Satisfaction With Device and Services as Measured by Orthotics and Prosthetics User's Survey (OPUS) Satisfaction With Device and Services
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.
Time frame: 11-12 weeks after surgery
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention A - Prefabricated Splint | Patient Satisfaction With Device and Services as Measured by Orthotics and Prosthetics User's Survey (OPUS) Satisfaction With Device and Services | Satisfaction with orthosis | 42.6 score on a scale | Standard Deviation 9.85 |
| Intervention A - Prefabricated Splint | Patient Satisfaction With Device and Services as Measured by Orthotics and Prosthetics User's Survey (OPUS) Satisfaction With Device and Services | Satisfaction with services | 42 score on a scale | Standard Deviation 4.76 |
| Intervention B - Custom Orthosis | Patient Satisfaction With Device and Services as Measured by Orthotics and Prosthetics User's Survey (OPUS) Satisfaction With Device and Services | Satisfaction with orthosis | 45 score on a scale | Standard Deviation 6.57 |
| Intervention B - Custom Orthosis | Patient Satisfaction With Device and Services as Measured by Orthotics and Prosthetics User's Survey (OPUS) Satisfaction With Device and Services | Satisfaction with services | 45 score on a scale | Standard Deviation 5.76 |
p-value: 0.917t-test, 2 sided
p-value: 0.837t-test, 2 sided