Comparison Between Four Types of Single Dose Hyaluronic Acid Injection in Patients With Knee Osteoarthritis
NCT ID: NCT01998308
Last Updated: 2015-09-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
200 participants
OBSERVATIONAL
2012-12-31
2019-12-31
Brief Summary
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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
Detailed Description
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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.
Conditions
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Study Design
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ECOLOGIC_OR_COMMUNITY
PROSPECTIVE
Study Groups
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Group 1
50 Knees will have single injection of Crespine gel
Crespine gel
50 Knees will have single injection of Crespine gel
Group 2
50 Knees will have single injection of 2 ampules of intragel
Intragel
50 Knees will have single injection of 2 ampules of Intragel
Group 3
50 knees will have single injection of crespine plus gel
Crespine plus gel
50 Knees will have single injection of Crespine Plus Gel
Group 4
50 knees will have single injection of Monovisc
Monovisc
50 Knees will have single injection of Monovisc
Interventions
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Crespine gel
50 Knees will have single injection of Crespine gel
Intragel
50 Knees will have single injection of 2 ampules of Intragel
Crespine plus gel
50 Knees will have single injection of Crespine Plus Gel
Monovisc
50 Knees will have single injection of Monovisc
Eligibility Criteria
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Inclusion Criteria
* patients with Osteoarthritis grade II and III according to Kellgren and Lawrence grading
Exclusion Criteria
* Active inflammation or infected processes
* Anticoagulant
* Known allergy to hyaluronic acid.
20 Years
70 Years
ALL
Yes
Sponsors
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October 6 University
OTHER
Responsible Party
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Mahmoud A Hafez, MSc Orth, Dip SICOT, FRCS Ed, MD
Mahmoud A Hafez
Principal Investigators
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Mahmoud A Hafez, Professor
Role: PRINCIPAL_INVESTIGATOR
October 6 University
Abdullah I Ammoura, Researcher
Role: STUDY_CHAIR
Bone and Joint Center
Locations
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October 6 University
Six October City, , Egypt
Countries
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Central Contacts
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Facility Contacts
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Mahmoud A Hafez, Professor
Role: primary
Abdullah I Ammoura, Researcher
Role: backup
Other Identifiers
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October6U-0001
Identifier Type: -
Identifier Source: org_study_id