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

• Conditions: Osteoarthritis
• Interventions: Drug: Crespine gel; Drug: Intragel; Drug: Crespine plus gel; Drug: Monovisc

• Registration Number: NCT01998308
• Lead Sponsor: October 6 University

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

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 Timeline

• Study Start: 2012-12
• Study First Submitted: 2013-11-16
• Study First Submitted QC: 2013-11-23
• Study First Posted: 2013-11-28
• Status Verified: 2015-09
• Last Update Submitted: 2015-09-28
• Last Update Posted: 2015-09-30
• Primary Completion: 2017-12
• Study Completion: 2019-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group 1	Crespine gel	50 Knees will have single injection of Crespine gel
Group 2	Intragel	50 Knees will have single injection of 2 ampules of intragel
Group 3	Crespine plus gel	50 knees will have single injection of crespine plus gel
Group 4	Monovisc	50 knees will have single injection of Monovisc

Primary Outcome Measures

Name	Time	Method
Lower extremity functional scale	up to 52 weeks

Secondary Outcome Measures

Name	Time	Method
Visual analog scale	up to 52 weeks
Kellgren and lawrence class grade	up to 52 weeks
Range of motion	up to 52 weeks

Trial Locations

Locations (1)

October 6 University; 🇪🇬 six October city, Egypt