Trial Outcomes & Findings for Effect of Compliance Counseling on Brace Success in Patients With Idiopathic Scoliosis (NCT NCT02412137)
NCT ID: NCT02412137
Last Updated: 2024-10-31
Results Overview
Final treatment outcome of bracing vs surgery (i.e. how many patients had surgery versus no surgery for their spinal deformity). For each patient this time frame varies, patient "A" may effectively wear a brace that controls their spinal deformity for 4 years and never need surgical intervention, patient "B" may effectively wear a brace for a year but has a spinal deformity that continues to get larger and need surgical intervention, and patient "C" may wear a brace less than prescribed (noncompliant) for 2 years and progress to surgery.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
245 participants
Primary outcome timeframe
up to 4 years, depending on length of bracing
Results posted on
2024-10-31
Participant Flow
Participant milestones
| Measure |
Counseled Patients
The counseled cohort will have their brace wear compliance documented on the Brace Progress Report after the Orthotist downloads the time/temperature data onto a laptop from the sensor reader (A piece of computer hardware which the sensor clips into and is attached to the laptop via the USB port). The Orthotist will then reset the temperature logger discs and reinstall them into the padding in the inside front of the brace in order to monitor the next period of brace wear. This group will then be counseled for about 10 minutes or less regarding their brace-wear using the Brace Progress report as a checklist.
Counseled cohort: This group will be counseled after brace temperature/date/time data is logged at each visit.
144 patients were enrolled into this arm, 2 dropped out, 21 were lost to follow-up, 28 were excluded.
|
Non-counseled Patients
The non-counseled cohort will have their brace wear compliance documented on the Brace Progress Report after the Orthotist downloads the time/temperature data onto a laptop from the sensor reader (A piece of computer hardware which the sensor clips into and is attached to the laptop via the USB port). The Orthotist will then reset the temperature logger discs and reinstall them into the padding in the inside front of the brace in order to monitor the next period of brace wear. This group will not be counseled, and will only receive standard clinical care.
Counseled cohort: This group will be counseled after brace temperature/date/time data is logged at each visit.
101 were enrolled into this arm, 9 were excluded, 14 were lost to follow-up.
|
|---|---|---|
|
Overall Study
STARTED
|
144
|
101
|
|
Overall Study
COMPLETED
|
93
|
78
|
|
Overall Study
NOT COMPLETED
|
51
|
23
|
Reasons for withdrawal
| Measure |
Counseled Patients
The counseled cohort will have their brace wear compliance documented on the Brace Progress Report after the Orthotist downloads the time/temperature data onto a laptop from the sensor reader (A piece of computer hardware which the sensor clips into and is attached to the laptop via the USB port). The Orthotist will then reset the temperature logger discs and reinstall them into the padding in the inside front of the brace in order to monitor the next period of brace wear. This group will then be counseled for about 10 minutes or less regarding their brace-wear using the Brace Progress report as a checklist.
Counseled cohort: This group will be counseled after brace temperature/date/time data is logged at each visit.
144 patients were enrolled into this arm, 2 dropped out, 21 were lost to follow-up, 28 were excluded.
|
Non-counseled Patients
The non-counseled cohort will have their brace wear compliance documented on the Brace Progress Report after the Orthotist downloads the time/temperature data onto a laptop from the sensor reader (A piece of computer hardware which the sensor clips into and is attached to the laptop via the USB port). The Orthotist will then reset the temperature logger discs and reinstall them into the padding in the inside front of the brace in order to monitor the next period of brace wear. This group will not be counseled, and will only receive standard clinical care.
Counseled cohort: This group will be counseled after brace temperature/date/time data is logged at each visit.
101 were enrolled into this arm, 9 were excluded, 14 were lost to follow-up.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
0
|
|
Overall Study
Lost to Follow-up
|
21
|
14
|
|
Overall Study
Physician Decision
|
28
|
9
|
Baseline Characteristics
Effect of Compliance Counseling on Brace Success in Patients With Idiopathic Scoliosis
Baseline characteristics by cohort
| Measure |
Counseled Patients
n=144 Participants
The counseled cohort will have their brace wear compliance documented on the Brace Progress Report after the Orthotist downloads the time/temperature data onto a laptop from the sensor reader (A piece of computer hardware which the sensor clips into and is attached to the laptop via the USB port). The Orthotist will then reset the temperature logger discs and reinstall them into the padding in the inside front of the brace in order to monitor the next period of brace wear. This group will then be counseled for about 10 minutes or less regarding their brace-wear using the Brace Progress report as a checklist.
Counseled cohort: This group will be counseled after brace temperature/date/time data is logged at each visit.
|
Non-counseled Patients
n=101 Participants
The non-counseled cohort will have their brace wear compliance documented on the Brace Progress Report after the Orthotist downloads the time/temperature data onto a laptop from the sensor reader (A piece of computer hardware which the sensor clips into and is attached to the laptop via the USB port). The Orthotist will then reset the temperature logger discs and reinstall them into the padding in the inside front of the brace in order to monitor the next period of brace wear. This group will not be counseled, and will only receive standard clinical care.
Counseled cohort: This group will be counseled after brace temperature/date/time data is logged at each visit.
|
Total
n=245 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
14.1 years
STANDARD_DEVIATION 1.52 • n=99 Participants
|
14.1 years
STANDARD_DEVIATION 1.82 • n=107 Participants
|
14.1 years
STANDARD_DEVIATION 1.65 • n=206 Participants
|
|
Sex: Female, Male
Female
|
128 Participants
n=99 Participants
|
93 Participants
n=107 Participants
|
221 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
24 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
144 participants
n=99 Participants
|
101 participants
n=107 Participants
|
245 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: up to 4 years, depending on length of bracingPopulation: 144 patients were enrolled into the counseled patients arm, 2 dropped out, 21 were lost to follow-up, 28 were excluded. 101 were enrolled into the non-counseled arm, 9 were excluded, 14 were lost to follow-up.
Final treatment outcome of bracing vs surgery (i.e. how many patients had surgery versus no surgery for their spinal deformity). For each patient this time frame varies, patient "A" may effectively wear a brace that controls their spinal deformity for 4 years and never need surgical intervention, patient "B" may effectively wear a brace for a year but has a spinal deformity that continues to get larger and need surgical intervention, and patient "C" may wear a brace less than prescribed (noncompliant) for 2 years and progress to surgery.
Outcome measures
| Measure |
Counseled Patients
n=144 Participants
The counseled cohort will have their brace wear compliance documented on the Brace Progress Report after the Orthotist downloads the time/temperature data onto a laptop from the sensor reader (A piece of computer hardware which the sensor clips into and is attached to the laptop via the USB port). The Orthotist will then reset the temperature logger discs and reinstall them into the padding in the inside front of the brace in order to monitor the next period of brace wear. This group will then be counseled for about 10 minutes or less regarding their brace-wear using the Brace Progress report as a checklist.
Counseled cohort: This group will be counseled after brace temperature/date/time data is logged at each visit.
|
Non-counseled Patients
n=101 Participants
The non-counseled cohort will have their brace wear compliance documented on the Brace Progress Report after the Orthotist downloads the time/temperature data onto a laptop from the sensor reader (A piece of computer hardware which the sensor clips into and is attached to the laptop via the USB port). The Orthotist will then reset the temperature logger discs and reinstall them into the padding in the inside front of the brace in order to monitor the next period of brace wear. This group will not be counseled, and will only receive standard clinical care.
Counseled cohort: This group will be counseled after brace temperature/date/time data is logged at each visit.
101 were enrolled into this arm, 9 were excluded, 14 were lost to follow-up.
|
|---|---|---|
|
Brace Progress Report (i.e. Informing the Patient How Often They Were Wearing the Brace Versus Not Informing the Patient)
No Surgery
|
67 participants
|
49 participants
|
|
Brace Progress Report (i.e. Informing the Patient How Often They Were Wearing the Brace Versus Not Informing the Patient)
Completion Participants
|
93 participants
|
78 participants
|
|
Brace Progress Report (i.e. Informing the Patient How Often They Were Wearing the Brace Versus Not Informing the Patient)
Surgery
|
26 participants
|
29 participants
|
Adverse Events
Counseled Patients
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Non-counseled Patients
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
Dr. Brandon Ramo
Texas Scottish Rite Hospital for Children
Phone: 2145597755
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place