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

October 6 University

Status: Unknown

Conditions: Osteoarthritis

Treatments: Drug: Intragel; Drug: Crespine gel; Drug: Crespine plus gel; Drug: Monovisc

Study type: Observational

Funder types: Other

Identifiers

NCT01998308

October6U-0001

Details and patient eligibility

About

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

Full 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.

Enrollment: 200 estimated patients

Sex: All

Ages: 20 to 70 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

200 participants in 4 patient groups

Group 1

Description:

50 Knees will have single injection of Crespine gel

Treatment:

Drug: Crespine gel

Group 2

Description:

50 Knees will have single injection of 2 ampules of intragel

Treatment:

Drug: Intragel

Group 3

Description:

50 knees will have single injection of crespine plus gel

Treatment:

Drug: Crespine plus gel

Group 4

Description:

50 knees will have single injection of Monovisc

Treatment:

Drug: Monovisc