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
|First Submitted Date ICMJE||January 15, 2007|
|First Posted Date ICMJE||January 17, 2007|
|Last Update Posted Date||January 18, 2007|
|Study Start Date ICMJE||March 2007|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE
|Original Primary Outcome Measures ICMJE||Same as current|
|Change History||Complete list of historical versions of study NCT00422643 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE||Not Provided|
|Original Secondary Outcome Measures ICMJE||Not Provided|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||The Effect of Intraaricular Knee Injections of Hyaluronic Acid (HA) on Bone and Cartilaginous Debris, as a Therapeutic Indicator|
|Official Title ICMJE||The Effect of Intraaricular Knee Injections of Hyaluronic Acid (HA) on Bone and Cartilaginous Debris, as a Therapeutic Indicator|
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.
1. patients with the diagnosis of Osteoarhtritis of the knee, graded according to Kellgren as grade 1-4
|Detailed Description||Not Provided|
|Study Type ICMJE||Interventional|
|Study Phase||Phase 4|
|Study Design ICMJE||Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Educational/Counseling/Training
|Condition ICMJE||Osteoarthritis of the Knee|
|Intervention ICMJE||Drug: Sodium hyaluronate (hyaluronic acid)|
|Study Arms||Not Provided|
|Publications *||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Unknown status|
|Original Enrollment ICMJE||Same as current|
|Study Completion Date||October 2007|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
|Ages||50 Years to 90 Years (Adult, Older Adult)|
|Accepts Healthy Volunteers||Yes|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Listed Location Countries ICMJE||Israel|
|Removed Location Countries|
|NCT Number ICMJE||NCT00422643|
|Other Study ID Numbers ICMJE||DEBICTIL|
|Has Data Monitoring Committee||Not Provided|
|U.S. FDA-regulated Product||Not Provided|
|IPD Sharing Statement||Not Provided|
|Responsible Party||Not Provided|
|Study Sponsor ICMJE||Assaf-Harofeh Medical Center|
|Collaborators ICMJE||Ferring Pharmaceuticals|
|PRS Account||Assaf-Harofeh Medical Center|
|Verification Date||January 2007|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP