Trial Outcomes & Findings for Influence of Custom Orthosis Post Carpometacarpal (CMC) Arthroplasty (NCT NCT05307510)
NCT ID: NCT05307510
Last Updated: 2024-10-08
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
21 participants
Primary outcome timeframe
11-12 weeks after surgery
Results posted on
2024-10-08
Participant Flow
Recruitment for participants began in April of 2022 and concluded in September of 2023.
Participant milestones
| Measure |
Intervention A - Prefabricated Splint
A prefabricated splint is provided to the client
Prefabricated splint: Subjects will be provided either a prefabricated splint
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
9
|
12
|
|
Overall Study
Data Collection I
|
9
|
12
|
|
Overall Study
Data Collection II
|
7
|
8
|
|
Overall Study
Data Collection III
|
6
|
5
|
|
Overall Study
COMPLETED
|
6
|
5
|
|
Overall Study
NOT COMPLETED
|
3
|
7
|
Reasons for withdrawal
| Measure |
Intervention A - Prefabricated Splint
A prefabricated splint is provided to the client
Prefabricated splint: Subjects will be provided either a prefabricated splint
|
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.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
3
|
6
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
Baseline Characteristics
Influence of Custom Orthosis Post Carpometacarpal (CMC) Arthroplasty
Baseline characteristics by cohort
| Measure |
Intervention A - Prefabricated Splint
n=9 Participants
A prefabricated splint is provided to the client
Prefabricated splint: Subjects will be provided either a prefabricated splint
|
Intervention B - Custom Orthosis
n=12 Participants
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.
|
Total
n=21 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
64.78 years
STANDARD_DEVIATION 7.68 • n=5 Participants
|
61.42 years
STANDARD_DEVIATION 8.93 • n=7 Participants
|
62.86 years
STANDARD_DEVIATION 8.39 • n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
7 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
African American
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Sandy Grading Scale
Grade I
|
9 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Sandy Grading Scale
other grades
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
VAS Pain Scale
Pain at rest
|
4.11 units on a scale
STANDARD_DEVIATION 2.93 • n=5 Participants
|
4.17 units on a scale
STANDARD_DEVIATION 2.76 • n=7 Participants
|
4.14 units on a scale
STANDARD_DEVIATION 2.72 • n=5 Participants
|
|
VAS Pain Scale
Pain at night
|
4.89 units on a scale
STANDARD_DEVIATION 3.88 • n=5 Participants
|
5.42 units on a scale
STANDARD_DEVIATION 2.94 • n=7 Participants
|
5.19 units on a scale
STANDARD_DEVIATION 3.25 • n=5 Participants
|
|
VAS Pain Scale
Pain in use
|
7.67 units on a scale
STANDARD_DEVIATION 2.4 • n=5 Participants
|
5.75 units on a scale
STANDARD_DEVIATION 1.82 • n=7 Participants
|
6.57 units on a scale
STANDARD_DEVIATION 2.25 • n=5 Participants
|
PRIMARY outcome
Timeframe: 11-12 weeks after surgeryThe 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.
Outcome measures
| Measure |
Intervention A - Prefabricated Splint
n=6 Participants
A prefabricated splint is provided to the client
Prefabricated splint: Subjects will be provided either a prefabricated splint
|
Intervention B - Custom Orthosis
n=5 Participants
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.
|
|---|---|---|
|
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
|
4.2 score on a scale
Standard Deviation 1.3
|
|
Change in Pain Post-operatively Using the Visual Analog Scale (Pain VAS)
Pain at night
|
5.3 score on a scale
Standard Deviation .816
|
5.8 score on a scale
Standard Deviation 2.6
|
|
Change in Pain Post-operatively Using the Visual Analog Scale (Pain VAS)
Pain in use
|
5 score on a scale
Standard Deviation 2.76
|
6 score on a scale
Standard Deviation 1.9
|
PRIMARY outcome
Timeframe: 11-12 weeks after surgerySandy 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.
Outcome measures
| Measure |
Intervention A - Prefabricated Splint
n=6 Participants
A prefabricated splint is provided to the client
Prefabricated splint: Subjects will be provided either a prefabricated splint
|
Intervention B - Custom Orthosis
n=5 Participants
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.
|
|---|---|---|
|
Change in Wound Dehiscence Post-operatively as Measured by Sandy Grading System
|
1 score on a scale
Standard Deviation 0
|
1 score on a scale
Standard Deviation 0
|
SECONDARY outcome
Timeframe: 11-12 weeks after surgeryGoniometric 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)
Outcome measures
| Measure |
Intervention A - Prefabricated Splint
n=6 Participants
A prefabricated splint is provided to the client
Prefabricated splint: Subjects will be provided either a prefabricated splint
|
Intervention B - Custom Orthosis
n=5 Participants
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.
|
|---|---|---|
|
Change in the Amount of Thumb CMC Active Range of Motion Post-operatively
Palmar Abduction
|
37.50 degrees
Standard Deviation 11.5
|
41 degrees
Standard Deviation 12
|
|
Change in the Amount of Thumb CMC Active Range of Motion Post-operatively
Radial Abduction
|
39.5 degrees
Standard Deviation 7.1
|
42.6 degrees
Standard Deviation 8.3
|
SECONDARY outcome
Timeframe: 11-12 weeks after surgeryThe QuickDash is a questionnaire about symptoms and ability to perform certain activities. Scores range from 0 (no disability) to 100 (severe disability).
Outcome measures
| Measure |
Intervention A - Prefabricated Splint
n=6 Participants
A prefabricated splint is provided to the client
Prefabricated splint: Subjects will be provided either a prefabricated splint
|
Intervention B - Custom Orthosis
n=5 Participants
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.
|
|---|---|---|
|
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
|
40.6 score on a scale
Standard Deviation 8.5
|
SECONDARY outcome
Timeframe: 11-12 weeks after surgeryFour 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.
Outcome measures
| Measure |
Intervention A - Prefabricated Splint
n=6 Participants
A prefabricated splint is provided to the client
Prefabricated splint: Subjects will be provided either a prefabricated splint
|
Intervention B - Custom Orthosis
n=5 Participants
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.
|
|---|---|---|
|
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 .12
|
.36 minutes
Standard Deviation .11
|
|
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 .22
|
1.35 minutes
Standard Deviation .35
|
|
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 .13
|
.33 minutes
Standard Deviation .05
|
|
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 .05
|
.14 minutes
Standard Deviation .02
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 11-12 weeks after surgeryA 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.
Outcome measures
| Measure |
Intervention A - Prefabricated Splint
n=6 Participants
A prefabricated splint is provided to the client
Prefabricated splint: Subjects will be provided either a prefabricated splint
|
Intervention B - Custom Orthosis
n=5 Participants
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.
|
|---|---|---|
|
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
|
45 score on a scale
Standard Deviation 6.57
|
|
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
|
45 score on a scale
Standard Deviation 5.76
|
OTHER_PRE_SPECIFIED outcome
Timeframe: baseline (~10days after surgery), 5-6 week after surgery, 11-12 weeks after surgeryPopulation: Insufficient data to report. Circumferential measurement at base of thumb did not capture distal edema. Consequently, surgical team did not collect this data.
A circumferential measurement at the base (metacarpal phalangeal joint) of the surgical thumb.
Outcome measures
Outcome data not reported
Adverse Events
Intervention A - Prefabricated Splint
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Intervention B - Custom Orthosis
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place