NCT01998308

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

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 200 (estimated)
• Sponsor: October 6 University · Academic / Other
• Sex: All
• Age: 20 Years – 70 Years
• Healthy volunteers: Accepted

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.

Conditions

• Osteoarthritis

Interventions

Type	Name	Description
DRUG	Crespine gel	50 Knees will have single injection of Crespine gel
DRUG	Intragel	50 Knees will have single injection of 2 ampules of Intragel
DRUG	Crespine plus gel	50 Knees will have single injection of Crespine Plus Gel
DRUG	Monovisc	50 Knees will have single injection of Monovisc

Timeline

• Start date: 2012-12-01
• Primary completion: 2017-12-01
• Completion: 2019-12-01
• First posted: 2013-11-28
• Last updated: 2015-09-30

Locations

1 site across 1 country: Egypt