NCT01442571

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P75+ for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

September 4, 2011

Completed
24 days until next milestone

First Posted

Study publicly available on registry

September 28, 2011

Completed
Last Updated

September 28, 2011

Status Verified

August 1, 2011

First QC Date

September 4, 2011

Last Update Submit

September 27, 2011

Conditions

Cartilage Injury

Keywords

Adult Men and Women, who underwent arthroscopy of the knee with cartilage injury of ICRS grade 2 or higher

Outcome Measures

Primary Outcomes (1)

  • IKDC (the International Knee Documentation Committee)

Study Arms (2)

Hyaluronic Acid Injection, pain, function

EXPERIMENTAL
Device: Hyaluronic Acid Injection

Saline Injection

PLACEBO COMPARATOR
Drug: Saline Injection

Interventions

Hyaluronic Acid InjectionDEVICE
Hyaluronic Acid Injection, pain, function
Saline InjectionDRUG
Saline Injection

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Jerusalem, Israel

Location

MeSH Terms

Conditions

Multiple Endocrine Neoplasia Type 1

Interventions

Sodium Chloride

Condition Hierarchy (Ancestors)

Multiple Endocrine NeoplasiaEndocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsNeoplasms, Multiple PrimaryNeoplastic Syndromes, HereditaryGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

ChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Central Study Contacts

Hadas Lemberg, PhD

CONTACT

00 972 2 6777572lhadas@hadassah.org.il

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 4, 2011

First Posted

September 28, 2011

Last Updated

September 28, 2011

Record last verified: 2011-08

Locations

IL(1)