Recruiting

Providence Brace

Sponsor:

OrthoGeorgia

Code:

NCT02227537

Conditions

Adolescence Idiopathic Scoliosis

Eligibility Criteria

Sex: All

Age: 10 - 14

Healthy Volunteers: Not accepted

Interventions

Providence Nighttime Bracing System

Providence Nighttime Bracing System

Study Details

Brief summary:

A multicenter, prospective, non-randomized, single-arm observational study evaluating the Providence nighttime bracing system in patients diagnosed with adolescence idiopathic scoliosis.

Conditions

Adolescence Idiopathic Scoliosis

Study ID

NCT02227537

Start date

Oct, 2014

Status verified date

Apr, 2015

Completion date

Aug, 2016

Anticipated

Primary completion date

Aug, 2016

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 10 - 14

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Subject/guardian is able to provide informed consent and must sign the Institutional Review Board approved Informed Consent Form;
  • Clinical/radiographic diagnosis of adolescence idiopathic scoliosis;
  • Male/female;
  • Skeletally immature (Risser grade 0, 1, or 2);
  • Cobb angle between 25-40 degrees;
  • Pre-menarchal or post-menarchal by no more than 1 year at the time of diagnosis;
  • Curve apex caudal to T6 vertebrae;
  • Physical and mental ability to adhere to bracing protocol;
  • Have agreed to refuse participation in another clinical trial for the duration of the study.

Exclusion Criteria:

  • History of previous surgical intervention or other invasive treatment for AIS;
  • History of orthotic treatment or other brace wear for the treatment of AIS;
  • Diagnosis of other musculoskeletal or developmental illness that might be responsible for the spinal curvature;
  • Tumor or malignant tumor in the spine;
  • Inability to communicate clearly in the English language;
  • Subjects with a Risser score ≥ 3;
  • Plans to relocate within the next 2 years;
  • Any subject the Principle Investigator deems as an unfit candidate.

Study Design

Enrollment

100 participants

Anticipated

Interventions and Outcome Measures

Arms

Adolescence idiopathic scoliosis

Patients must be at least 10 years of age with a risser score of 0, 1, or 2

Interventions

Providence Nighttime Bracing System

Providence Nighttime Bracing System

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.

Primary outcome measure

  • Curve progression [ Time Frame: subjects will be followed up for a period of 24 months from their first visit after receiving the Providence nighttime bracing system ]

Central Contacts and Locations

Central contacts

Craig C Odum

478-254-5377codum@orthoga.org

Locations

Georgia Pediatric Orthopaedics

Recruiting

Macon, Georgia, United States, 31201

Contacts

Craig C Odum

478-254-5377codum@orthoga.org

OrthoGeorgia

Recruiting

Macon, Georgia, United States, 31201

Contacts

Craig C Odum

478-254-5377codum@orthoga.org

More Information

Sponsor

OrthoGeorgia

Last update posted

Apr 21, 2015

Last verified

Apr, 2015

Keywords

  • Adolescence Idiopathic Scoliosis
  • nighttime Bracing
  • Providence

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by OrthoGeorgia on 2015-04-21.