- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01998308
Comparison Between Four Types of Single Dose Hyaluronic Acid Injection in Patients With Knee Osteoarthritis
Intra-articular Hyaluronic Acid Knee Injection: Randomized Control Trial.
Study design:
Allocation: Randomized. Endpoint Classification: Comparative Study. Intervention model: Parallel Assignment. Masking: Double Blind (Subject, Assessed) Primary purpose: Comparison.
Official Title: Intra-articular hyaluronic acid knee injection: randomized control trail.
Primary outcome measures:
- Lower extremity functional scale
- Visual analogue scale
- Range of motion
- Kellgren and Lawrence class grade Estimated enrollment: 100 Study start date: December 2012 Estimated study completion date: June 2013 Estimated primary completion date: December 2013
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The study include:
200 knees, 50 knees will have single injection of Crespine gel, and 50 knees will have single injection of 2 ampules of Intragel, also 50 knees will have single injection of Crespine plus gel and 50 knees will have single injection of Monovisc The patient will be randomized to Crespine gel or to Intragel, and Crespine Plus gel or to Monovisc
Inclusion Criteria: patients with Osteoarthritis grade II and III according to Kellgren and Lawrence grading were included.
Exclusion Criteria: patients with autoimmune illnesses, active inflammation or infected processes, anticoagulant, and known allergy to hyaluronic acid.
Target parameters:
- Lower extremity functional scale
- Visual analogue scale
- Range of motion
- Kellgren and Lawrence class grade
Eligibility:
Ages Eligible for Study: 20 years to 70 years Genders Eligible for Study: both Accepts Healthy Volunteers: no
Criteria
Inclusion Criteria:
- Age of patients between 20 and 70 years
- patients with Osteoarthritis grade II and III according to Kellgren and Lawrence grading
Exclusion Criteria:
- Autoimmune illnesses
- Active inflammation or infected processes
- Anticoagulant
- Known allergy to hyaluronic acid.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Mahmoud A Hafez, Professor
- Phone Number: 002 0100 1116624
- Email: mhafez@msn.com
Study Contact Backup
- Name: Abdullah I Ammoura, Researcher
- Phone Number: 00201118581127
- Email: abdala.ammora@mhafez.net
Study Locations
-
-
-
six October city, Egypt
- Recruiting
- October 6 University
-
Contact:
- Mahmoud A Hafez, Professor
- Phone Number: 00201001116624
- Email: mhafez@msn.com
-
Contact:
- Abdullah I Ammoura, Researcher
- Phone Number: 00201118581127
- Email: mixecano1991@gmail.com
-
Principal Investigator:
- Mahmoud A Hafez, professor
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Age of patients between 20 and 70 years
- patients with Osteoarthritis grade II and III according to Kellgren and Lawrence grading
Exclusion Criteria:
- Autoimmune illnesses
- Active inflammation or infected processes
- Anticoagulant
- Known allergy to hyaluronic acid.
Study Plan
How is the study designed?
Design Details
- Observational Models: Ecologic or Community
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Group 1
50 Knees will have single injection of Crespine gel
|
50 Knees will have single injection of Crespine gel
|
Group 2
50 Knees will have single injection of 2 ampules of intragel
|
50 Knees will have single injection of 2 ampules of Intragel
|
Group 3
50 knees will have single injection of crespine plus gel
|
50 Knees will have single injection of Crespine Plus Gel
|
Group 4
50 knees will have single injection of Monovisc
|
50 Knees will have single injection of Monovisc
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Lower extremity functional scale
Time Frame: up to 52 weeks
|
up to 52 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Visual analog scale
Time Frame: up to 52 weeks
|
up to 52 weeks
|
Kellgren and lawrence class grade
Time Frame: up to 52 weeks
|
up to 52 weeks
|
Range of motion
Time Frame: up to 52 weeks
|
up to 52 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Abdullah I Ammoura, Researcher, Bone and Joint Center
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- October6U-0001
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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