The Effect of Intraaricular Knee Injections of Hyaluronic Acid (HA) on Bone and Cartilaginous Debris, as a Therapeutic Indicator

January 17, 2007 updated by: Assaf-Harofeh Medical Center

Osteoarthritis is the most common disease effecting human beings with incidence of about 20% and prevalence close to 80% of the adult population. It is most common after the age of 60 years and more in females with the ratio 4:1 F:M. Osteoarthritis Can be present in every hyaline joint, but is mostly damaging to the weight bearing joints, the knees and hips. At the final stage of cartilage destruction (from wear and tear) joint replacement is the solution. Since these operations were introduced about 50 years ago, the indications and the number of yearly procedures has been increasing with alarming speed. Last year in the united states, about 500,000 Total Knee procedures were done, exceeding Total Hip replacements.

By 2030, close to 4.5 million joint replacement procedures are expected in the United States, the majority of which will be knee replacements. Joint replacement is the solution for the final stage of damaged cartilage. In early and advanced stages of cartilage wear and specifically in the knee H.A. acts as an anti inflammatory and lubricant agent, reducing the knee pain and improving knee motion and function.

The biological effect of H.A. is well documented in clinical studies and less with scientific evidence derived from patients themselves.

Our study proposal briefly is, as follows:

60 patients with evidence of osteoarthritis of the knees will join the study after I.R.B. (Helsinki Committee) approval. All of them will be examined, x-rays will be performed and blood tests will exclude patients with infections or inflammatory disease. A V.A.S. (Visual Analog Score) and SF-36 evaluation form will be completed prior to each intraarticular injection, in addition to a complete medical examination. The enrolled patients will receive the usual three intraarticular knee injections of H.A.(Arthrease), but prior to each injection, the joint will be aspirated and the joint fluid will be analyzed for Chondroitin sulfate type I and type II as described further in this project.

Three and six months after the third initial injections, the patients will recalled and joint fluid will be aspirated again, followed by an H.A. injections, if symptomatic.

This study is the only one ever proposed, for evaluating joint debris qualitatively and quantitatively. It will provide clinical information as well as objective data on the preservation of the joint cartilage. Hopefully, this study will provide additional information such as the relationship between the presence of debris and symptomatic vs. asymptomatic patients. It may help in determining how long the injected H.A. has an effect and whether serial and periodical injections are indicated.

Inclusion criteria:

1. patients with the diagnosis of Osteoarhtritis of the knee, graded according to Kellgren as grade 1-4

Exclusion criteria:

  1. Patients that suffer from acute septic arthritis.
  2. Patients that treated with coumadin and/or other anti-coagulant drugs
  3. Patients that show mental or physical conditions, which preclude compliance with study and/or device.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

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Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Israel
      • Zerifin, Israel, 71700
        • Orthopedic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

50 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion criteria:

  • Patients with the diagnosis of Osteoarhtritis of the knee, graded according to Kellgren as grade 1-4

Exclusion criteria:

  • Patients that suffer from acute septic arthritis.
  • Patients that treated with coumadin and/or other anti-coagulant drugs
  • Patients that show mental or physical conditions, which preclude compliance with study and/or device.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Educational/Counseling/Training
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
To provide additional information such as the relationship between the presence of debris and symptomatic vs. asymptomatic patients.
Determining how long the injected H.A. has an effect and whether serial and periodical injections are indicated.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Assaf-Harofeh Medical Center

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Ferring Pharmaceuticals

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: ronen debi, md, Assaf Harofe Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2007

Study Completion

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2007

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 15, 2007

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 16, 2007

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 17, 2007

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 18, 2007

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 17, 2007

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • DEBICTIL

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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