Durolane Versus Phosphate Buffered Saline (PBS) in Knee Osteoarthritis

NCT ID: NCT01753830

Last Updated: 2022-08-26

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-12-31

Study Completion Date

2014-02-28

Brief Summary

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The purpose of the study is to determine whether a single intra-articular injection of Durolane 4.5 mL is superior to a single injection of PBS 4.5 mL for the relief of joint pain in patients with osteoarthritis of the knee.

Detailed Description

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Conditions

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Knee Osteoarthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Durolane

Single intraarticular injection of Durolane

Group Type EXPERIMENTAL

Durolane

Intervention Type DEVICE

4.5 mL

PBS

Single intraarticular injection of PBS

Group Type PLACEBO_COMPARATOR

PBS

Intervention Type DEVICE

4.5 mL

Interventions

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Durolane

4.5 mL

Intervention Type DEVICE

PBS

4.5 mL

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Body Mass Index (BMI) ≤ 35 kg/m2
* Symptomatic osteoarthritis (OA) of the knee
* K L severity grade 1 or 2
* If bilateral OA, contralateral knee K L severity grade 0 or 1

Exclusion Criteria

* Has clinically apparent tense effusion of the index knee
* Has had surgery on the symptomatic knee within the previous 12 months or arthroscopy in the index knee in the past 3 months
* Has any painful orthopedic disorders of the back or hip
* Has a joint disorder other than osteoarthritis in the index knee
Minimum Eligible Age

40 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Galderma R&D

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Nebojsa Skrepnik, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Tucson Orthopaedic Institute

Locations

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Anniston, Alabama, United States

Site Status

Mobile, Alabama, United States

Site Status

Phoenix, Arizona, United States

Site Status

Tucson, Arizona, United States

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Hot Springs, Arkansas, United States

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Beverly Hills, California, United States

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El Cajon, California, United States

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Boulder, Colorado, United States

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Danbury, Connecticut, United States

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Trumbull, Connecticut, United States

Site Status

Lauderdale Lakes, Florida, United States

Site Status

Pinellas Park, Florida, United States

Site Status

South Miami, Florida, United States

Site Status

Boise, Idaho, United States

Site Status

Meridian, Idaho, United States

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Evansville, Indiana, United States

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New Orleans, Louisiana, United States

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Wheaton, Maryland, United States

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Kalamazoo, Michigan, United States

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Springfield, Missouri, United States

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Oklahoma City, Oklahoma, United States

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Duncansville, Pennsylvania, United States

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Wyomissing, Pennsylvania, United States

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Charleston, South Carolina, United States

Site Status

Norfolk, Virginia, United States

Site Status

Countries

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United States

Other Identifiers

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35GA1203

Identifier Type: -

Identifier Source: org_study_id

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