Clinical trial NCT01998308: Comparison Between Four Types of Single Dose Hyaluronic Acid Injection in Patients With Knee Osteoarthritis
Official title: Intra-articular Hyaluronic Acid Knee Injection: Randomized Control Trial.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Osteoarthritis
Lead sponsor: October 6 University
Sponsor class: OTHER
First posted: 2013-11-28
Enrollment: 200
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patient with knee osteoarthiritis

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.

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.

Primary outcomes:
measure: Lower extremity functional scale
timeFrame: up to 52 weeks
Secondary outcomes:
measure: Visual analog scale
timeFrame: up to 52 weeks
measure: Kellgren and lawrence class grade
timeFrame: up to 52 weeks
measure: Range of motion
timeFrame: up to 52 weeks
Other outcomes:
Locations:
city: six October city
country: Egypt
facility: October 6 University
Study officials:
affiliation: October 6 University
name: Mahmoud A Hafez, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: Bone and Joint Center
name: Abdullah I Ammoura, Researcher
role: STUDY_CHAIR
References: