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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
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01998308
Enrollment
200
Registered
2013-11-28
Start date
2012-12-31
Completion date
2019-12-31
Last updated
2015-09-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoarthritis

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.

Interventions

DRUGCrespine gel

50 Knees will have single injection of Crespine gel

50 Knees will have single injection of 2 ampules of Intragel

DRUGCrespine plus gel

50 Knees will have single injection of Crespine Plus Gel

50 Knees will have single injection of Monovisc

Sponsors

October 6 University
Lead SponsorOTHER

Study design

Observational model
ECOLOGIC_OR_COMMUNITY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
20 Years to 70 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frame
Lower extremity functional scaleup to 52 weeks

Secondary

MeasureTime frame
Visual analog scaleup to 52 weeks
Kellgren and lawrence class gradeup to 52 weeks
Range of motionup to 52 weeks

Countries

Egypt

Contacts

Primary ContactMahmoud A Hafez, Professor
mhafez@msn.com002 0100 1116624
Backup ContactAbdullah I Ammoura, Researcher
abdala.ammora@mhafez.net00201118581127

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026