Hyaluronic Acid Injection Post Arthroscopy - Does it Impr... | NCT01442571

Studies
Hyaluronic Acid Injection Post Arthroscopy - Does it Improve Immediate Function? Double Blind Controlled Prospective Study

NCT01442571

Sponsor

Hadassah Medical Organization

Status

Unknown status

Last Update Posted

Sep 28, 2011Estimated

Enrollment

100Estimated

Phase

Phase 1Phase 2

Conditions

Cartilage Injury

Interventions

Hyaluronic Acid Injection
Saline Injection

Countries

Israel

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

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2011

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Not provided

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Sep 4, 2011

First Submission Date that Met QC Criteria

Sep 27, 2011

First Posted Date

Sep 28, 2011Estimated

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 27, 2011

Last Update Posted Date

Sep 28, 2011Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

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

The proposed research is to examine the effect of injecting a large volume of HA (10cc) at the time of post arthroscopy suture removal (9-11 day post surgery), in patients with cartilage damage of ICRS grade 2 and above in one of the knee compartments.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Hyaluronic Acid Injection, pain, function	Experimental		Device: Hyaluronic Acid Injection
Saline Injection	Placebo Comparator		Drug: Saline Injection

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Hyaluronic Acid Injection	Device		Hyaluronic Acid Injection, pain, function
Saline Injection

Measure	Description	Time Frame
IKDC (the International Knee Documentation Committee)

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Adult Men and Women, who underwent arthroscopy of the knee with cartilage injury of ICRS grade 2 or higher in one of the compartments (in addition to other injuries such as meniscal tear and cruciate ligament).

Exclusion Criteria:

Patients with known rheumatic disorders.
Known hypersensitivity to HA.
Synovial diseases like PVNS, under 18y old.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Role	Phone	Extension	Email
Hadas Lemberg, PhD	Contact	00 972 2 6777572		lhadas@hadassah.org.il

Condition Browse Module

MeSH Terms

ID	Term
D018761	Multiple Endocrine Neoplasia Type 1

Ancestor Terms

ID	Term
D009377	Multiple Endocrine Neoplasia
D004701	Endocrine Gland Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D012965	Sodium Chloride

Ancestor Terms

ID	Term
D002712	Chlorides
D006851	Hydrochloric Acid
D017606	Chlorine Compounds
D007287	Inorganic Chemicals

Browse Leaves

Not provided

Browse Branches

Not provided