Ignite Creation Date:
2025-12-24 @ 2:20 PM
Ignite Modification Date:
2026-01-03 @ 8:45 PM
Study NCT ID:
NCT03282695
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-03-04
First Post:
2017-09-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ozone Therapy in Patients on Waiting List for Surgery Due to Disc Herniation: Prospective, Post-authorization Study
Sponsor:
Bernardino Clavo, MD, PhD
Organization:
Study Overview
Official Title:
Ozone Therapy in Patients on Waiting List for Surgery Due to Disc Herniation: Prospective, Post-authorization Study
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2025-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
O3HDCIRUGIA
Brief Summary:
The main objective of this study is to estimate the cost-effectiveness of ozone therapy in patients on the waiting list for surgery due to disc herniation.
Detailed Description:
A cohort study (patients on the waiting list for surgery due to herniated disc) will be carried out, to which the treatment with ozone will be offered, without giving up the planned surgical intervention.
The main objective of this prospective, post-authorization follow-up study is to estimate the cost-effectiveness of ozone therapy (compared to standard care) in patients with disc herniation waiting for surgery (by microdiscectomy). Besides utilities of patients with disc herniation on a waiting list for surgery will be estimated, social/economic burden of disc herniation will be quantified and a decision aid will be developed and applied.
The main outcome measures are "Direct hospital cost", "Percentage of executed surgeries" and "Change in sciatic pain". In addition, data on health-related quality of life and resource utilization will be collected which will permit to estimate the incremental cost-effectiveness ratio (ICER), comparing incremental costs and quality adjusted life years (QALY).
The variables will be collected at the beginning, on the day of treatment and at 1, 3, 6, 12 and 24 months. The enrollment period will be 24 months. The follow-up period will be 24 months.
The results of the study will allow a better understanding of the value of ozone therapy in the management of patients on the waiting list for herniated disc surgery. In addition, it will contribute to the development of a more patient-centered health system.
The main objective of this prospective, post-authorization follow-up study is to estimate the cost-effectiveness of ozone therapy (compared to standard care) in patients with disc herniation waiting for surgery (by microdiscectomy). Besides utilities of patients with disc herniation on a waiting list for surgery will be estimated, social/economic burden of disc herniation will be quantified and a decision aid will be developed and applied.
The main outcome measures are "Direct hospital cost", "Percentage of executed surgeries" and "Change in sciatic pain". In addition, data on health-related quality of life and resource utilization will be collected which will permit to estimate the incremental cost-effectiveness ratio (ICER), comparing incremental costs and quality adjusted life years (QALY).
The variables will be collected at the beginning, on the day of treatment and at 1, 3, 6, 12 and 24 months. The enrollment period will be 24 months. The follow-up period will be 24 months.
The results of the study will allow a better understanding of the value of ozone therapy in the management of patients on the waiting list for herniated disc surgery. In addition, it will contribute to the development of a more patient-centered health system.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: