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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02180776
Other study ID # CPR-ORTHO01-2012
Secondary ID
Status Completed
Phase N/A
First received January 23, 2014
Last updated July 1, 2014
Start date June 2012
Est. completion date March 2014

Study information

Verified date July 2014
Source Aspen Medical Products
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug AdministrationUnited States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

The objective of this study is to evaluate clinical effectiveness and the effect on quality of life of an inelastic thoracolumbarasacral orthosis in male and female hyperkyphotic patients with moderate to severe back pain disability and to demonstrate the safety of the intervention through detailed reporting and analysis of adverse events.


Recruitment information / eligibility

Status Completed
Enrollment 16
Est. completion date March 2014
Est. primary completion date March 2014
Accepts healthy volunteers No
Gender Both
Age group 19 Years and older
Eligibility Inclusion Criteria:

- Patients with moderate to complete disability (crippled) as defined by a score of 21% to 80% on the baseline evaluation of the Oswestry Back Pain Disability Questionnaire;

- Patients diagnosed with kyphosis and have a Cobb angle of at least 55 degrees;

- Willing and able to comply with the study procedures and provide written informed consent to participate in the study.

Exclusion Criteria:

- Patients under the age of 19;

- Pregnant patients or patients who are considering future pregnancies;

- Patients who were participating in any other investigational device or drug study or whose participation in a previous investigational study within 30 days of study entry may, in the opinion of the clinical investigator, impact analysis of this orthotic;

- Patients who, in the clinical judgment of the investigator, are not suitable for this study; Patients who, in the investigators opinion, are mentally or legally incapacitated preventing informed consent or unable to read or understand written material;

- Patients who are unable or unwilling to return to the study center for follow-up visits.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Other:
Summit 456 TLSO
Thoracolumbarsacral orthosis

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Aspen Medical Products

Outcome

Type Measure Description Time frame Safety issue
Other ODI scores between the intervention group versus control group Weeks 8, 12, 16, 20 and 24 No
Other SF-26v2 Survey scores in the intervention versus the control group Baseline and weeks 4, 8, 12 and 24. No
Other Cost and return on investment of the LSO intervention 24 weeks No
Other Number of adverse events associated with the LSO intervention Baseline and weeks 2, 3, 4, 8, 12, 16, 20 and 24 No
Primary Mean difference in the Oswestry Disability Index Scores of the intervention versus control groups 4 weeks No
Secondary Measured amount of opioid medication consumed in the intervention group versus control group Baseline and weeks 2,3,4,8,12,16,20 and 24 No
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