Safety and Efficacy of Intra-articular Ozone Injections for Knee Osteoarthritis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-09-01

Study Completion Date

2018-08-01

Brief Summary

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Prospective, Interventional, Non-Randomized, Open Label, Single Group Assignment, Single Center.

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Detailed Description

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Conditions

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Osteoarthritis Knee

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

A sequential series of patients receiving steroid injections was compared to a sequential series of patients receiving ozone injections

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

the outcome assessor was not aware of the therapy administered

Study Groups

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OZONE

injection of ozone gas

Group Type EXPERIMENTAL

Ozone gas

Intervention Type DEVICE

Injection of ozone gas intra articularly

control

injeciton of steroids intra articularly

Group Type ACTIVE_COMPARATOR

Steroid injection

Intervention Type DRUG

Injection of steroids (diprospan) intra articularly

Interventions

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Ozone gas

Injection of ozone gas intra articularly

Intervention Type DEVICE

Steroid injection

Injection of steroids (diprospan) intra articularly

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 55 to 79 years of age
* Symptomatic Knee osteoarthritis
* VAS pain intensity is at least 40 mm on a 100 mm scale
* Must be physically and mentally willing and able to comply with post-operative rehabilitation and routinely schedule clinical and radiographic visits.

Exclusion Criteria

* Any known tumor of the ipsilateral knee.
* Any known infection of the treated knee.
* Osteoarthritis of the operated knee Kelgren Lawrence \< grade 2.
* Chemotherapy treatment in the past 12 months.
* Patients who are sensitive to ozone.
* Pregnant women, or breastfeeding women.
* Evidence of any significant systemic disease (such as but not limited to HIV infection, hepatitis infection or HTLV infection), known coagulopathies, that might compromise the Subject's welfare.
* Substance abuse or alcohol abuse.
* Participation in other clinical trials in parallel to this study.

Minimum Eligible Age

55 Years

Maximum Eligible Age

79 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No