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Effectiveness Trial for Evaluating IAHA for PFPS

NCT01811654 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2020-02-26

Study results available
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Summary

The purpose of this study is to determine the safety and effectiveness of intra-articular hyaluronan (IAHA) injections for the treatment of symptomatic patellofemoral pain syndrome (PFPS) and determine if this treatment can provide incremental clinical benefits over standard care for patients with this diagnosis.

Conditions

  • Patellofemoral Pain Syndrome

Interventions

DEVICE

Intra-Articular Hyaluronic Acid-Euflexxa

IAHA was approved by the FDA in 1997 as a synovial fluid replacement device to help relieve the pain associated with knee osteoarthritis (OA) in patients who fail to respond adequately to conservative treatment and simple analgesics. In this study, IAHA, specifically Euflexxa, will be used off-label to determine whether patients afflicted with PFPS will experience similar analgesic effects as seen in those with OA.

Sponsors & Collaborators

Principal Investigators

  • Dennis Cardone, DO · NYU Langone Medical Center

  • Philip Band, PhD · NYU Langone Medical Center/Hospital for Joint Disease

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-04-30
Primary Completion
2016-12-07
Completion
2017-03-04
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01811654 on ClinicalTrials.gov