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Comparison Between Four Types of Single Dose Hyaluronic Acid Injection in Patients With Knee Osteoarthritis

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ClinicalTrials.gov Identifier: NCT01998308
Recruitment Status : Unknown
Verified September 2015 by Mahmoud A Hafez, MSc Orth, Dip SICOT, FRCS Ed, MD, October 6 University.
Recruitment status was:  Recruiting
First Posted : November 28, 2013
Last Update Posted : September 30, 2015
Sponsor:
Information provided by (Responsible Party):
Mahmoud A Hafez, MSc Orth, Dip SICOT, FRCS Ed, MD, October 6 University

Study Description
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:

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

Condition or disease Intervention/treatment
Osteoarthritis Drug: Crespine gel Drug: Intragel Drug: Crespine plus gel Drug: Monovisc

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 Design
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 200 participants
Observational Model: Ecologic or Community
Time Perspective: Prospective
Target Follow-Up Duration: 24 Months
Official Title: Intra-articular Hyaluronic Acid Knee Injection: Randomized Control Trial.
Study Start Date : December 2012
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

Groups and Cohorts
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Group/Cohort Intervention/treatment
Group 1
50 Knees will have single injection of Crespine gel
 Drug: Crespine gel
50 Knees will have single injection of Crespine gel
Group 2
50 Knees will have single injection of 2 ampules of intragel
 Drug: Intragel
50 Knees will have single injection of 2 ampules of Intragel
Group 3
50 knees will have single injection of crespine plus gel
 Drug: Crespine plus gel
50 Knees will have single injection of Crespine Plus Gel
Group 4
50 knees will have single injection of Monovisc
 Drug: Monovisc
50 Knees will have single injection of Monovisc


Outcome Measures
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Primary Outcome Measures :
  1. Lower extremity functional scale [ Time Frame: up to 52 weeks ]

Secondary Outcome Measures :
  1. Visual analog scale [ Time Frame: up to 52 weeks ]
  2. Kellgren and lawrence class grade [ Time Frame: up to 52 weeks ]
  3. Range of motion [ Time Frame: up to 52 weeks ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
patient with knee osteoarthiritis
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.
Contacts and Locations
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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): NCT01998308


Contacts
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Contact: Mahmoud A Hafez, Professor 002 0100 1116624 mhafez@msn.com
Contact: Abdullah I Ammoura, Researcher 00201118581127 abdala.ammora@mhafez.net

Locations
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Egypt
October 6 University Recruiting
six October city, Egypt
Contact: Mahmoud A Hafez, Professor    00201001116624    mhafez@msn.com   
Contact: Abdullah I Ammoura, Researcher    00201118581127    mixecano1991@gmail.com   
Principal Investigator: Mahmoud A Hafez, professor         
Sponsors and Collaborators
October 6 University
Investigators
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Principal Investigator: Mahmoud A Hafez, Professor October 6 University
Study Chair: Abdullah I Ammoura, Researcher Bone and Joint Center
More Information
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Additional Information:

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Responsible Party: Mahmoud A Hafez, MSc Orth, Dip SICOT, FRCS Ed, MD, Mahmoud A Hafez, October 6 University
ClinicalTrials.gov Identifier: NCT01998308    
Other Study ID Numbers: October6U-0001
First Posted: November 28, 2013    Key Record Dates
Last Update Posted: September 30, 2015
Last Verified: September 2015
Additional relevant MeSH terms:
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Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Hyaluronic Acid
 Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Viscosupplements
Protective Agents