Ignite Creation Date:
2024-05-05 @ 5:18 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00422643
Status:
UNKNOWN
Last Update Posted:
2007-01-18
First Post:
2007-01-15
Brief Title:
The Effect of Intraaricular Knee Injections of Hyaluronic Acid HA on Bone and Cartilaginous Debris as a Therapeutic Indicator
Sponsor:
Assaf-Harofeh Medical Center
Organization:
Assaf-Harofeh Medical Center
Study Overview
Official Title:
The Effect of Intraaricular Knee Injections of Hyaluronic Acid HA on Bone and Cartilaginous Debris as a Therapeutic Indicator
Status:
UNKNOWN
Status Verified Date:
2007-01
Last Known Status:
NOT_YET_RECRUITING
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:
None
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 41 FM 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 500000 Total Knee procedures were done exceeding Total Hip replacements
By 2030 close to 45 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 HA acts as an anti inflammatory and lubricant agent reducing the knee pain and improving knee motion and function
The biological effect of HA 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 IRB 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 VAS 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 HAArthrease 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 HA 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 HA 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 andor other anti-coagulant drugs
3 Patients that show mental or physical conditions which preclude compliance with study andor device
By 2030 close to 45 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 HA acts as an anti inflammatory and lubricant agent reducing the knee pain and improving knee motion and function
The biological effect of HA 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 IRB 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 VAS 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 HAArthrease 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 HA 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 HA 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 andor other anti-coagulant drugs
3 Patients that show mental or physical conditions which preclude compliance with study andor device
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None