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

Osteoarthritis Clinical Trial

Official title:

Intra-articular Hyaluronic Acid Knee Injection: Randomized Control Trial.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01998308
• Other study ID #: October6U-0001
• Status: Recruiting
• Phase: N/A
• First received: November 16, 2013
• Last updated: September 28, 2015
• Start date: December 2012
• Est. completion date: December 2019

Study information

• Verified date: September 2015
• Source: October 6 University
• Contact: Mahmoud A Hafez, Professor
• Phone: 002 0100 1116624
• Email: mhafez[@]msn.com
• Is FDA regulated: No
• Health authority: Egypt: Ministry of Health and Population
• Study type: Observational [Patient Registry]

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 2019
• Est. primary completion date: December 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 70 Years

Eligibility

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

Observational Model: Ecologic or Community, Time Perspective: Prospective

Related Conditions & MeSH terms

• Osteoarthritis

Intervention

Drug:
• 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

Locations

Country	Name	City	State
Egypt	October 6 University	six October city

Sponsors (1)

Lead Sponsor	Collaborator
October 6 University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Lower extremity functional scale		up to 52 weeks	Yes
Secondary	Visual analog scale		up to 52 weeks	Yes
Secondary	Kellgren and lawrence class grade		up to 52 weeks	Yes
Secondary	Range of motion		up to 52 weeks	Yes