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

NCT ID: NCT01442571

Last Updated: 2011-09-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1/PHASE2

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Brief Summary

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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

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Conditions

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Cartilage Injury

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Study Groups

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Hyaluronic Acid Injection, pain, function

Group Type EXPERIMENTAL

Hyaluronic Acid Injection

Intervention Type DEVICE

Saline Injection

Group Type PLACEBO_COMPARATOR

Saline Injection

Intervention Type DRUG

Interventions

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Hyaluronic Acid Injection

Intervention Type DEVICE

Saline Injection

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hadassah Medical Organization

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Jerusalem, , Israel

Site Status

Countries

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Israel

Central Contacts

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Hadas Lemberg, PhD

Role: CONTACT

00 972 2 6777572

Other Identifiers

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sports01-CTIL-HMO

Identifier Type: -

Identifier Source: org_study_id