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Evaluation of the Providence Nighttime Brace for the Treatment of Adolescence Idiopathic Scoliosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02227537
Recruitment Status : Unknown
Verified April 2015 by William Dasher, MD, OrthoGeorgia.
Recruitment status was:  Recruiting
First Posted : August 28, 2014
Last Update Posted : April 21, 2015
Sponsor:
Information provided by (Responsible Party):
William Dasher, MD, OrthoGeorgia

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

Condition or disease Intervention/treatment
Adolescence Idiopathic Scoliosis Device: Providence Nighttime Bracing System

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.

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation of the Providence Nighttime Brace for the Treatment of Adolescence Idiopathic Scoliosis
Study Start Date : October 2014
Estimated Primary Completion Date : August 2016
Estimated Study Completion Date : August 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Scoliosis

Group/Cohort Intervention/treatment
Adolescence idiopathic scoliosis
Patients must be at least 10 years of age with a risser score of 0, 1, or 2
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.




Primary Outcome Measures :
  1. 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 ]
    • The percentage of patients who have ≤5o curve progression and the percentage of patients who have ≥6 o progression at maturity;
    • The percentage of patients with curves exceeding 45o at maturity and the percentage who have had surgery recommended/undergone;
    • 2 year follow-up beyond maturity to determine the percentage of patients who subsequently undergo surgery.

    Routine follow-up visits will be scheduled 6 months apart (1st visit after brace fitting, 6, 12, 18 and 24 months) up to 24 months. At each of these visits, the patient will undergo a history & physical, PA radiographs, Cobb Angle assessment, Adams Forward Bending test, Neurological examination, outcome questionnaire's, concomitant medications, and adverse event recordings.



Secondary Outcome Measures :
  1. Compliance [ Time Frame: subjects will be followed up for a period of 24 months from their first visit after receiving the Providence nighttime bracing system ]
    A temperature data logger will record and monitor patient compliance of brace wear. To not create undue awareness to these recordings patients will be informed the temperature readings are being monitored for patient comfort and ease of brace wear. Reconciliation of data logger recordings will be conducted every 3 months.

  2. Functionality [ Time Frame: subjects will be followed up for a period of 24 months from their first visit after receiving the Providence nighttime bracing system ]
    Both study subjects and their guardians will be asked to fill out an Adolescent Health Assessment. Based on the Version 2.0 Pediatrics-Parent/ Adolescent Outcomes Instrument also commonly referred to as the PODCI ("Pediatric Outcomes Data Collection Instrument")

  3. physical health and personal image [ Time Frame: subjects will be followed up for a period of 24 months from their first visit after receiving the Providence nighttime bracing system ]
    Both study subjects and their guardians will be asked to fill out an Adolescent Health Assessment. Based on the Version 2.0 Pediatrics-Parent/ Adolescent Outcomes Instrument also commonly referred to as the PODCI ("Pediatric Outcomes Data Collection Instrument")



Information from the National Library of Medicine

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Ages Eligible for Study:   10 Years to 14 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
up to 100 adolescent male/female will be enrolled at up to 4 sites in the US. Patients must be at least 10 years of age. Participants who receive treatment must have been diagnosed with adolescent idiopathic scoliosis without other significant spinal pathology. Appropriate participant selection will be accomplished through the integration of clinical and radiological parameters while ruling out other confounding sources of back pain or curvature. Subjects will be included who demonstrate a Cobb angle between 25-40 degrees. Participants must have radiographic evidence of a Risser grade of 0, 1, or 2. All chronic disease process and other possible sources for spinal curvature will be excluded by thorough history and physical examination.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02227537


Contacts
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Contact: Craig C Odum 478-254-5377 codum@orthoga.org

Locations
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United States, Georgia
Georgia Pediatric Orthopaedics Recruiting
Macon, Georgia, United States, 31201
Contact: Craig C Odum    478-254-5377    codum@orthoga.org   
OrthoGeorgia Recruiting
Macon, Georgia, United States, 31201
Contact: Craig C Odum    478-254-5377    codum@orthoga.org   
Sponsors and Collaborators
OrthoGeorgia
Investigators
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Principal Investigator: William B Dasher, MD OrthoGeorgia
Principal Investigator: Eric D Lincoln, DO Georgia Pediatric Orthopaedics
Principal Investigator: Winston R Jeshuran, MD OrthoGeorgia
Principal Investigator: Wayne Kelley, MD OrthoGeorgia
Principal Investigator: Randolph Devereaux, PhD Mercer University School of Medicine
Principal Investigator: Hamza H Awad, MD, PhD Mercer University School of Medicine

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Responsible Party: William Dasher, MD, Orthopaedic Spine Surgeon, OrthoGeorgia
ClinicalTrials.gov Identifier: NCT02227537    
Other Study ID Numbers: OG12-04-13
First Posted: August 28, 2014    Key Record Dates
Last Update Posted: April 21, 2015
Last Verified: April 2015
Keywords provided by William Dasher, MD, OrthoGeorgia:
Adolescence Idiopathic Scoliosis
nighttime Bracing
Providence
Additional relevant MeSH terms:
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Scoliosis
Spinal Curvatures
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases