Comparison Between Four Types of Single Dose Hyaluronic A... | NCT01998308

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

NCT01998308

Sponsor

October 6 University

Status

Unknown status

Last Update Posted

Sep 30, 2015Estimated

Enrollment

200Estimated

Phase

Not provided

Conditions

Osteoarthritis

Interventions

Crespine gel
Intragel
Crespine plus gel
Monovisc

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2015

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2012

Primary Completion Date

Dec 2017Estimated

Completion Date

Dec 2019Estimated

First Submitted Date

Nov 16, 2013

First Submission Date that Met QC Criteria

Nov 23, 2013

First Posted Date

Nov 28, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 28, 2015

Last Update Posted Date

Sep 30, 2015Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Mahmoud A Hafez, MSc Orth, Dip SICOT, FRCS Ed, MD, Mahmoud A Hafez, October 6 UniversityPrincipal Investigator

Lead Sponsor

October 6 UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

24 Months

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

200Estimated

Arms/Interventions Module

Arm Groups

Label	Description	Intervention Names
Group 1	50 Knees will have single injection of Crespine gel	Drug: Crespine gel
Group 2	50 Knees will have single injection of 2 ampules of intragel	Drug: Intragel
Group 3	50 knees will have single injection of crespine plus gel	Drug: Crespine plus gel
Group 4	50 knees will have single injection of Monovisc	Drug: Monovisc

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Crespine gel	Drug	50 Knees will have single injection of Crespine gel	Group 1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Lower extremity functional scale		up to 52 weeks

Secondary Outcomes

Measure	Description	Time Frame
Visual analog scale		up to 52 weeks
Kellgren and lawrence class grade		up to 52 weeks
Range of motion

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

patient with knee osteoarthiritis

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Mahmoud A Hafez, Professor	Contact	002 0100 1116624		mhafez@msn.com
Abdullah I Ammoura, Researcher	Contact	00201118581127		abdala.ammora@mhafez.net

Overall Officials

Name	Affiliation	Role
Mahmoud A Hafez, Professor	October 6 University	Principal Investigator
Abdullah I Ammoura, Researcher	Bone and Joint Center	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
October 6 University	Recruiting	Six October City			Egypt

Type	Date	Date Unknown
Release	Feb 23, 2021
Reset	Mar 17, 2021

Submission Tracking

Estimated Results First Submitted Date

Feb 23, 2021

First MCP Posted Date

Not provided

Submission Infos

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
Feb 23, 2021			Mar 17, 2021

Condition Browse Module

MeSH Terms

ID	Term
D010003	Osteoarthritis

Ancestor Terms

ID	Term
D001168	Arthritis
D007592	Joint Diseases
D009140	Musculoskeletal Diseases
D012216	Rheumatic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D005782	Gels
D006820	Hyaluronic Acid

Ancestor Terms

ID	Term
D003102	Colloids
D045424	Complex Mixtures
D004304	Dosage Forms
D004364	Pharmaceutical Preparations

Browse Leaves

Not provided

Browse Branches

Not provided