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

Study Overview
=================
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.

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

Conditions
-----------------
Osteoarthritis

Intervention / Treatment
-----------------
* Drug: Crespine gel
* Drug: Intragel
* Drug: Crespine plus gel
* Drug: Monovisc


Participation Criteria
=================
Eligibility 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.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group 1<br>50 Knees will have single injection of Crespine gel | Drug: Crespine gel<br>* 50 Knees will have single injection of Crespine gel<br>|
| Group 2<br>50 Knees will have single injection of 2 ampules of intragel | Drug: Intragel<br>* 50 Knees will have single injection of 2 ampules of Intragel<br>|
| Group 3<br>50 knees will have single injection of crespine plus gel | Drug: Crespine plus gel<br>* 50 Knees will have single injection of Crespine Plus Gel<br>|
| Group 4<br>50 knees will have single injection of Monovisc | Drug: Monovisc<br>* 50 Knees will have single injection of Monovisc<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lower extremity functional scale |  | up to 52 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual analog scale |  | up to 52 weeks | 
| Kellgren and lawrence class grade |  | up to 52 weeks | 
| Range of motion |  | up to 52 weeks |