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This study aims to compare post-surgical outcomes of individuals who receive either a custom orthosis or prefabricated splint after carpometacarpal arthroplasty.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention A - prefabricated splint | Active Comparator | A prefabricated splint is provided to the client |
|
| Intervention B - custom orthosis | Experimental | a custom orthosis (wrist splint with thumb spica) is fabricated by an occupational therapist |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prefabricated splint | Device | Subjects will be provided either a prefabricated splint |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 11-12 weeks after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 11-12 weeks after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 11-12 weeks after surgery |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Laura Schmelzer, PhD | The University of Toledo | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Toledo Medical Center | Toledo | Ohio | 43606 | United States |
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Recruitment for participants began in April of 2022 and concluded in September of 2023.
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| ID | Title | Description |
|---|---|---|
| FG000 | Intervention A - Prefabricated Splint | A prefabricated splint is provided to the client Prefabricated splint: Subjects will be provided either a prefabricated splint |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | Intervention A - Prefabricated Splint | A prefabricated splint is provided to the client Prefabricated splint: Subjects will be provided either a prefabricated splint |
| BG001 | Intervention B - Custom Orthosis |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Standard Deviation | score on a scale | 11-12 weeks after surgery |
|
on average 12 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Intervention A - Prefabricated Splint | A prefabricated splint is provided to the client Prefabricated splint: Subjects will be provided either a prefabricated splint |
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The collaborating surgeon's standard practice patterns included the provision of a hand-based thumb orthosis at DC II. This unanticipated standard practice pattern significantly limits conclusions that can be drawn from the data regarding between group differences in the outcomes.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Laura Schmelzer | The University of Toledo | 419-530-5068 | laura.schmelzer@utoledo.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 21, 2022 | Jun 4, 2024 | Prot_SAP_000.pdf |
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| Custom Orthosis | Device | Subjects will be evaluated by an occupational therapist who will fabricate a 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) |
The QuickDash is a questionnaire about symptoms and ability to perform certain activities. Scores range from 0 (no disability) to 100 (severe disability). |
| 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. | 11-12 weeks after surgery |
| 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. | baseline (~10days after surgery), 5-6 week after surgery, 11-12 weeks after surgery |
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.
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Sandy Grading Scale | Description of wound dehiscence. Scale contains 6 grades (I, Ia, II, IIa, III, IIIa). I indicates no clinical signs of microbiological confirmation or infection. | Count of Participants | Participants |
|
| VAS Pain Scale | Pain Visual Analog Scale (VAS) is a self-report measure with a range of 0 = no pain to 10 = worst pain. Participants report pain at rest, in use, and at night. | Mean | Standard Deviation | units on a scale |
|
|
|
|
| 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. | Posted | Mean | Standard Deviation | score on a scale | 11-12 weeks after surgery |
|
|
|
|
| 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) | Posted | Mean | Standard Deviation | degrees | 11-12 weeks after surgery |
|
|
|
|
| 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). | Posted | Mean | Standard Deviation | score on a scale | 11-12 weeks after surgery |
|
|
|
|
| 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. | Posted | Mean | Standard Deviation | minutes | 11-12 weeks after surgery |
|
|
|
|
| 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. | Posted | Mean | Standard Deviation | score on a scale | 11-12 weeks after surgery |
|
|
|
|
| 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. | Insufficient data to report. Circumferential measurement at base of thumb did not capture distal edema. Consequently, surgical team did not collect this data. | Posted | baseline (~10days after surgery), 5-6 week after surgery, 11-12 weeks after surgery |
|
|
| 0 |
| 9 |
| 0 |
| 9 |
| 0 |
| 9 |
| EG001 | 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. | 0 | 12 | 0 | 12 | 0 | 12 |
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Radial Abduction Surgical Hand
| t-test, 2 sided |
| .521 |
| Mean Difference (Net) |
| -3.1 |
| 2-Sided |
| 95 |
| -13.6 |
| 7.4 |
| Superiority |
Statistical analysis is underpowered. N is too low. |
| Opening and closing safety pins |
|
| Managing coins |
|
Lacing and tying a shoe
| t-test, 2 sided |
| .947 |
The threshold for statistical significance was p < 0.6 |
| Superiority |
Statistical analysis is underpowered. N is too low. |
| Opening and closing safety pins | t-test, 2 sided | .828 | The threshold for statistical significance was p < 0.6 | Superiority | Statistical analysis is underpowered. N is too low. |
| Managing coins | t-test, 2 sided | .169 | The threshold for statistical significance was p < 0.6 | Superiority | Statistical analysis is underpowered. N is too low. |
| .837 |
The threshold for statistical significance was p < 0.6 |
| Superiority |
Statistical analysis is underpowered. N is too small |