Trial Outcomes & Findings for Use of Compression Glove to Prevent Complications After Distal Radius Fractures: a Randomized Controlled Trial (NCT NCT01118715)
NCT ID: NCT01118715
Last Updated: 2020-11-04
Results Overview
Confirmed cases of Post-traumatic Carpal Tunnel Syndrome (CTS) or Complex Regional Pain Syndrome (CRPS)
TERMINATED
NA
128 participants
2 wks-24 wks
2020-11-04
Participant Flow
The initial protocol had 94 participants. Analysis was run, however, numbers were trending but not significant. Additional participants were then enrolled to increase the power of the study, leading to a larger participant number(128) than the study originally intended to have. There is no intention to continue enrolling subjects.
Participant milestones
| Measure |
Compression Glove
Patients in this group have a compression glove incorporated into their splint for 2 weeks post-op, and wear a glove underneath their cast for 3 weeks. The patient then wears the glove at night after cast removal.
Compression glove: A compression glove worn during recovery from distal radius fracture
|
Control
Patients in this group undergo standard recovery procedures. This includes a splint worn for 2 weeks post-op, followed by a short arm cast worn for the next 3 weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
68
|
60
|
|
Overall Study
COMPLETED
|
68
|
60
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Compression Glove
n=68 Participants
Patients in this group have a compression glove incorporated into their splint for 2 weeks post-op, and wear a glove underneath their cast for 3 weeks. The patient then wears the glove at night after cast removal.
Compression glove: A compression glove worn during recovery from distal radius fracture
|
Control
n=60 Participants
Patients in this group undergo standard recovery procedures. This includes a splint worn for 2 weeks post-op, followed by a short arm cast worn for the next 3 weeks.
|
Total
n=128 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
57 years
STANDARD_DEVIATION 19.9 • n=68 Participants
|
59.6 years
STANDARD_DEVIATION 15.3 • n=60 Participants
|
58.22 years
STANDARD_DEVIATION 18.00 • n=128 Participants
|
|
Sex: Female, Male
Female
|
57 Participants
n=68 Participants
|
46 Participants
n=60 Participants
|
103 Participants
n=128 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=68 Participants
|
14 Participants
n=60 Participants
|
25 Participants
n=128 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Injured wrist
Right
|
30 Participants
n=68 Participants
|
32 Participants
n=60 Participants
|
62 Participants
n=128 Participants
|
|
Injured wrist
Left
|
38 Participants
n=68 Participants
|
28 Participants
n=60 Participants
|
66 Participants
n=128 Participants
|
|
Pain Scale
|
5.1 units on a scale
STANDARD_DEVIATION 2.7 • n=68 Participants
|
6.21 units on a scale
STANDARD_DEVIATION 12.7 • n=60 Participants
|
5.17 units on a scale
STANDARD_DEVIATION 2.95 • n=128 Participants
|
PRIMARY outcome
Timeframe: 2 wks-24 wksPopulation: 'Number Analyzed' is broken down by group (Glove/No Glove) and time frame (2-24 weeks). The overall number of participants analyzed is not consistent with numbers provided in the participant flow module (total participants=128) because not all participants attended all follow-up appointments.
Confirmed cases of Post-traumatic Carpal Tunnel Syndrome (CTS) or Complex Regional Pain Syndrome (CRPS)
Outcome measures
| Measure |
2 Weeks
n=123 Participants
Count of patients with a new CTS or CRPS diagnosis at 2 weeks post-surgery.
|
5 Weeks
n=116 Participants
Count of patients with a new CTS or CRPS diagnosis at 5 weeks post-surgery.
|
12 Weeks
n=100 Participants
Count of patients with a new CTS or CRPS diagnosis at 12 weeks post-surgery.
|
24 Weeks
n=86 Participants
Count of patients with a new CTS or CRPS diagnosis at 24 weeks post-surgery.
|
|---|---|---|---|---|
|
Incidence of Post-traumatic Carpal Tunnel Syndrome (CTS) or Complex Regional Pain Syndrome (CRPS)
No Glove · new dx of CTS or CRPS
|
0 Participants
|
4 Participants
|
4 Participants
|
0 Participants
|
|
Incidence of Post-traumatic Carpal Tunnel Syndrome (CTS) or Complex Regional Pain Syndrome (CRPS)
No Glove · no new dx of CTS or CRPS
|
58 Participants
|
52 Participants
|
44 Participants
|
47 Participants
|
|
Incidence of Post-traumatic Carpal Tunnel Syndrome (CTS) or Complex Regional Pain Syndrome (CRPS)
Glove · new dx of CTS or CRPS
|
0 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
|
Incidence of Post-traumatic Carpal Tunnel Syndrome (CTS) or Complex Regional Pain Syndrome (CRPS)
Glove · no new dx of CTS or CRPS
|
65 Participants
|
59 Participants
|
50 Participants
|
39 Participants
|
SECONDARY outcome
Timeframe: 2 wks- 24 weeksPopulation: The overall number of participants analyzed is not consistent with numbers provided in the participant flow module (total participants=128) because not all participants attended all follow-up appointments. In addition, QAQC uncovered several cases of appointment records with missing or invalid data.
Circumference of Wrist/Finger by Glove or No Glove
Outcome measures
| Measure |
2 Weeks
n=99 Participants
Count of patients with a new CTS or CRPS diagnosis at 2 weeks post-surgery.
|
5 Weeks
n=97 Participants
Count of patients with a new CTS or CRPS diagnosis at 5 weeks post-surgery.
|
12 Weeks
n=70 Participants
Count of patients with a new CTS or CRPS diagnosis at 12 weeks post-surgery.
|
24 Weeks
n=56 Participants
Count of patients with a new CTS or CRPS diagnosis at 24 weeks post-surgery.
|
|---|---|---|---|---|
|
Edema
Glove 4th Finger
|
5.56 centimeters
Standard Deviation .68
|
5.46 centimeters
Standard Deviation .68
|
5.50 centimeters
Standard Deviation .68
|
5.56 centimeters
Standard Deviation .71
|
|
Edema
No Glove - Wrist Circumference
|
18.09 centimeters
Standard Deviation 1.34
|
17.53 centimeters
Standard Deviation 1.36
|
16.98 centimeters
Standard Deviation 1.37
|
16.74 centimeters
Standard Deviation 1.24
|
|
Edema
Glove - Wrist Circumference
|
17.66 centimeters
Standard Deviation 1.46
|
16.98 centimeters
Standard Deviation 1.50
|
16.75 centimeters
Standard Deviation 1.60
|
17.01 centimeters
Standard Deviation 1.56
|
|
Edema
No Glove 1st Finger
|
6.94 centimeters
Standard Deviation .61
|
6.84 centimeters
Standard Deviation .59
|
6.59 centimeters
Standard Deviation .56
|
6.50 centimeters
Standard Deviation .44
|
|
Edema
Glove 1st Finger
|
6.61 centimeters
Standard Deviation .70
|
6.38 centimeters
Standard Deviation .66
|
6.57 centimeters
Standard Deviation .68
|
6.62 centimeters
Standard Deviation .79
|
|
Edema
No Glove 2nd Finger
|
6.77 centimeters
Standard Deviation .64
|
6.67 centimeters
Standard Deviation .61
|
6.37 centimeters
Standard Deviation .56
|
6.28 centimeters
Standard Deviation .41
|
|
Edema
Glove 2nd Finger
|
6.47 centimeters
Standard Deviation .72
|
6.20 centimeters
Standard Deviation .70
|
6.31 centimeters
Standard Deviation .73
|
6.43 centimeters
Standard Deviation .83
|
|
Edema
No Glove 3rd Finger
|
6.29 centimeters
Standard Deviation .58
|
6.31 centimeters
Standard Deviation .62
|
5.99 centimeters
Standard Deviation .52
|
5.84 centimeters
Standard Deviation .41
|
|
Edema
Glove 3rd Finger
|
6.09 centimeters
Standard Deviation .69
|
5.86 centimeters
Standard Deviation .69
|
5.85 centimeters
Standard Deviation .73
|
5.98 centimeters
Standard Deviation .76
|
|
Edema
No Glove 4th Finger
|
5.71 centimeters
Standard Deviation .51
|
5.82 centimeters
Standard Deviation .53
|
5.58 centimeters
Standard Deviation .50
|
5.45 centimeters
Standard Deviation .41
|
SECONDARY outcome
Timeframe: 2 wks-24 wksPopulation: The overall number of participants analyzed is not consistent with numbers provided in the participant flow module (total participants=128) because not all participants attended all follow-up appointments. In addition, QAQC uncovered several cases of appointment records with missing or invalid data. Flexion data missing for 3 subjects and extension data missing for 1 subject at 2 wk visit.
Count of participants (by group) that were capable or full extension or flexion at each encounter.
Outcome measures
| Measure |
2 Weeks
n=98 Participants
Count of patients with a new CTS or CRPS diagnosis at 2 weeks post-surgery.
|
5 Weeks
n=97 Participants
Count of patients with a new CTS or CRPS diagnosis at 5 weeks post-surgery.
|
12 Weeks
n=70 Participants
Count of patients with a new CTS or CRPS diagnosis at 12 weeks post-surgery.
|
24 Weeks
n=56 Participants
Count of patients with a new CTS or CRPS diagnosis at 24 weeks post-surgery.
|
|---|---|---|---|---|
|
Range of Motion
No Glove - Full Flexion
|
24 Participants
|
25 Participants
|
32 Participants
|
28 Participants
|
|
Range of Motion
Glove - Full Flexion
|
20 Participants
|
31 Participants
|
34 Participants
|
26 Participants
|
|
Range of Motion
No Glove - Full Extension
|
45 Participants
|
44 Participants
|
33 Participants
|
29 Participants
|
|
Range of Motion
Glove - Full Extension
|
44 Participants
|
47 Participants
|
35 Participants
|
26 Participants
|
SECONDARY outcome
Timeframe: 5 wks-24 wksPopulation: The overall number of participants analyzed is not consistent with numbers provided in the participant flow module (total participants=128) because not all participants attended all follow-up appointments. In addition, QAQC uncovered several cases of appointment records with missing or invalid data.
Grip strength measured using a hand dynamometer at each visit except @ 2-weeks; grip strength was not measured at 2-weeks because of post-op activity restrictions recommended by the treating physician
Outcome measures
| Measure |
2 Weeks
n=116 Participants
Count of patients with a new CTS or CRPS diagnosis at 2 weeks post-surgery.
|
5 Weeks
n=100 Participants
Count of patients with a new CTS or CRPS diagnosis at 5 weeks post-surgery.
|
12 Weeks
n=86 Participants
Count of patients with a new CTS or CRPS diagnosis at 12 weeks post-surgery.
|
24 Weeks
Count of patients with a new CTS or CRPS diagnosis at 24 weeks post-surgery.
|
|---|---|---|---|---|
|
Grip Strength
No Glove
|
6.83 kg
Standard Deviation 6.14
|
17.79 kg
Standard Deviation 9.17
|
20.73 kg
Standard Deviation 11.69
|
—
|
|
Grip Strength
Glove
|
7.39 kg
Standard Deviation 6.04
|
18.10 kg
Standard Deviation 10.44
|
23.45 kg
Standard Deviation 10.28
|
—
|
SECONDARY outcome
Timeframe: 2 wks- 24 wksPopulation: The overall number of participants analyzed is not consistent with numbers provided in the participant flow module (total participants=128) because not all participants attended all follow-up appointments. In addition, QAQC uncovered several cases of appointment records with missing or invalid data.
Disabilities of the Arm, Shoulder and Hand questionnaire (DASH) is 30-item questionnaire designed to quanitfy functional outcomes of the upper extremity and measure symptoms of pain, physical, emotional, and social domains associated with musculoskeletal disorders of the upper limb. Scores can range from 0-100 with 0 indicating NO disability and 100 indicating extreme disability.
Outcome measures
| Measure |
2 Weeks
n=123 Participants
Count of patients with a new CTS or CRPS diagnosis at 2 weeks post-surgery.
|
5 Weeks
n=116 Participants
Count of patients with a new CTS or CRPS diagnosis at 5 weeks post-surgery.
|
12 Weeks
n=100 Participants
Count of patients with a new CTS or CRPS diagnosis at 12 weeks post-surgery.
|
24 Weeks
n=86 Participants
Count of patients with a new CTS or CRPS diagnosis at 24 weeks post-surgery.
|
|---|---|---|---|---|
|
DASH Score
No Glove
|
58.12 score on a scale
Standard Deviation 22.11
|
39.52 score on a scale
Standard Deviation 21.18
|
20.51 score on a scale
Standard Deviation 17.24
|
11.50 score on a scale
Standard Deviation 14.28
|
|
DASH Score
Glove
|
62.14 score on a scale
Standard Deviation 19.75
|
44.98 score on a scale
Standard Deviation 22.30
|
16.42 score on a scale
Standard Deviation 16.54
|
10.32 score on a scale
Standard Deviation 14.53
|
SECONDARY outcome
Timeframe: 2 wks- 24 wksPopulation: The overall number of participants analyzed is not consistent with numbers provided in the participant flow module (total participants=128) because not all participants attended all follow-up appointments. In addition, QAQC uncovered several cases of appointment records with missing or invalid data.
Assessment of pain using a numerical rating scale of 0-10, where 0=no pain and 10=worst possible pain
Outcome measures
| Measure |
2 Weeks
n=123 Participants
Count of patients with a new CTS or CRPS diagnosis at 2 weeks post-surgery.
|
5 Weeks
n=116 Participants
Count of patients with a new CTS or CRPS diagnosis at 5 weeks post-surgery.
|
12 Weeks
n=100 Participants
Count of patients with a new CTS or CRPS diagnosis at 12 weeks post-surgery.
|
24 Weeks
n=86 Participants
Count of patients with a new CTS or CRPS diagnosis at 24 weeks post-surgery.
|
|---|---|---|---|---|
|
Pain on Numerical Rating Scale
No Glove
|
2.93 units on a scale
Standard Deviation 2.03
|
2.42 units on a scale
Standard Deviation 2.11
|
1.32 units on a scale
Standard Deviation 1.61
|
.81 units on a scale
Standard Deviation 1.06
|
|
Pain on Numerical Rating Scale
Glove
|
3.24 units on a scale
Standard Deviation 2.31
|
1.75 units on a scale
Standard Deviation 1.57
|
1.03 units on a scale
Standard Deviation 1.48
|
.73 units on a scale
Standard Deviation 1.08
|
Adverse Events
Compression Glove
Control
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