Trials / Unknown
UnknownNCT02227537
Evaluation of the Providence Nighttime Brace for the Treatment of Adolescence Idiopathic Scoliosis
- Status
- Unknown
- Phase
- —
- Study type
- Observational
- Enrollment
- 100 (estimated)
- Sponsor
- OrthoGeorgia · Academic / Other
- Sex
- All
- Age
- 10 Years – 14 Years
- Healthy volunteers
- Not accepted
Summary
A multicenter, prospective, non-randomized, single-arm observational study evaluating the Providence nighttime bracing system in patients diagnosed with adolescence idiopathic scoliosis.
Detailed description
This study is designed as a multicenter, prospective, non-randomized, single arm observational study. A temperature probe and data logger will be attached to the Providence brace to monitor patient compliance wear time. Subjects will be blinded to temperature sensor readings to maximize objectivity of brace wear.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Providence Nighttime Bracing System | Providence Nighttime Bracing System |
| DEVICE | Providence Nighttime Bracing System | The Providence brace is a polypropylene plastic, acrylic framed, system designed to apply corrective forces to scoliatic curves achieving correction or reduction of scoliosis. |
Timeline
- Start date
- 2014-10-01
- Primary completion
- 2016-08-01
- Completion
- 2016-08-01
- First posted
- 2014-08-28
- Last updated
- 2015-04-21
Locations
2 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT02227537. Inclusion in this directory is not an endorsement.