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

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ClinicalTrials.gov Identifier: NCT00422643
Recruitment Status : Unknown
Verified January 2007 by Assaf-Harofeh Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : January 17, 2007
Last Update Posted : January 18, 2007
Sponsor:
Collaborator:
Ferring Pharmaceuticals
Information provided by:
Assaf-Harofeh Medical Center

Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Osteoarthritis of the Knee Drug: Sodium hyaluronate (hyaluronic acid) Phase 4

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Educational/Counseling/Training
Official Title: The Effect of Intraaricular Knee Injections of Hyaluronic Acid (HA) on Bone and Cartilaginous Debris, as a Therapeutic Indicator
Study Start Date : March 2007
Estimated Study Completion Date : October 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis
U.S. FDA Resources




Primary Outcome Measures :
  1. To provide additional information such as the relationship between the presence of debris and symptomatic vs. asymptomatic patients.
  2. Determining how long the injected H.A. has an effect and whether serial and periodical injections are indicated.


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   50 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

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): NCT00422643


Contacts
Contact: nahum halperin, prof 972-8-9779432 ext 3 debyroay@012.net.il

Locations
Israel
Orthopedic Not yet recruiting
Zerifin, Israel, 71700
Contact: nahum halperin, prof    972-8-9779432    debyroay@012/net.il   
Principal Investigator: nahum halperin, prof         
Sponsors and Collaborators
Assaf-Harofeh Medical Center
Ferring Pharmaceuticals
Investigators
Principal Investigator: ronen debi, md assaf harofe medical center

ClinicalTrials.gov Identifier: NCT00422643     History of Changes
Other Study ID Numbers: DEBICTIL
First Posted: January 17, 2007    Key Record Dates
Last Update Posted: January 18, 2007
Last Verified: January 2007

Keywords provided by Assaf-Harofeh Medical Center:
OA,HA,Intra-articular

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Hyaluronic Acid
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Viscosupplements
Protective Agents