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

September 28, 2015 updated by: Mahmoud A Hafez, MSc Orth, Dip SICOT, FRCS Ed, MD, October 6 University

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

Unknown

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

Observational

Enrollment (Anticipated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • six October city, Egypt
        • Recruiting
        • October 6 University
        • Contact:
          • Mahmoud A Hafez, Professor
          • Phone Number: 00201001116624
          • Email: mhafez@msn.com
        • Contact:
        • Principal Investigator:
          • Mahmoud A Hafez, professor

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

patient with knee osteoarthiritis

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
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

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

This is where you will find people and organizations involved with this study.

Sponsor

October 6 University

Investigators

  • Study Chair: Abdullah I Ammoura, Researcher, Bone and Joint Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2012

Primary Completion (Anticipated)

December 1, 2017

Study Completion (Anticipated)

December 1, 2019

Study Registration Dates

First Submitted

November 16, 2013

First Submitted That Met QC Criteria

November 23, 2013

First Posted (Estimate)

November 28, 2013

Study Record Updates

Last Update Posted (Estimate)

September 30, 2015

Last Update Submitted That Met QC Criteria

September 28, 2015

Last Verified

September 1, 2015

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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