Comparison Between Four Types of Single Dose Hyaluronic Acid Injection in Patients With Knee Osteoarthritis
Intra-articular Hyaluronic Acid Knee Injection: Randomized Control Trial.
1 other identifier
observational
200
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Dec 2012
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2012
CompletedFirst Submitted
Initial submission to the registry
November 16, 2013
CompletedFirst Posted
Study publicly available on registry
November 28, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2019
CompletedSeptember 30, 2015
September 1, 2015
5 years
November 16, 2013
September 28, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Lower extremity functional scale
up to 52 weeks
Secondary Outcomes (3)
Visual analog scale
up to 52 weeks
Kellgren and lawrence class grade
up to 52 weeks
Range of motion
up to 52 weeks
Study Arms (4)
Group 1
50 Knees will have single injection of Crespine gel
Group 2
50 Knees will have single injection of 2 ampules of intragel
Group 3
50 knees will have single injection of crespine plus gel
Group 4
50 knees will have single injection of Monovisc
Interventions
Eligibility Criteria
patient with knee osteoarthiritis
You may qualify if:
- Age of patients between 20 and 70 years
- patients with Osteoarthritis grade II and III according to Kellgren and Lawrence grading
You may not qualify if:
- Autoimmune illnesses
- Active inflammation or infected processes
- Anticoagulant
- Known allergy to hyaluronic acid.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
October 6 University
Six October City, Egypt
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mahmoud A Hafez, Professor
October 6 University
- STUDY CHAIR
Abdullah I Ammoura, Researcher
Bone and Joint Center
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- ECOLOGIC OR COMMUNITY
- Time Perspective
- PROSPECTIVE
- Target Duration
- 24 Months
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Mahmoud A Hafez
Study Record Dates
First Submitted
November 16, 2013
First Posted
November 28, 2013
Study Start
December 1, 2012
Primary Completion
December 1, 2017
Study Completion
December 1, 2019
Last Updated
September 30, 2015
Record last verified: 2015-09