Intra-articular Hyaluronic Acid Injection for Therapy-resistant Patellofemoral Pain Syndrome

November 6, 2016 updated by: Jordan Raugust, University of Calgary

Intra-articular Hyaluronic Acid Injection for Therapy-resistant Patellofemoral Pain Syndrome: an Open-label, Randomized, Delayed-start Clinical Trial

Patellofemoral pain syndrome (PFPS) is the most common overuse injury seen in the athletic population, particularly amongst runners. The standard of care treatment for PFPS is a comprehensive active rehabilitation program. Eighty percent of patients with PFPS report improvement in their symptoms with such a program. Unfortunately, the remaining twenty percent fail to achieve adequate symptom relief with rehabilitation alone. Considering the enormous number of individuals running for fitness, PFPS represents a significant challenge to public health as the investigators strive to encourage active living in our society.

A relationship between PFPS and the development of patellofemoral osteoarthritis (PFOA) has been suggested in scientific literature. Given that intra-articular viscosupplementation (hyaluronic acid) injections have shown clinically significant symptom improvement in knee osteoarthritis, and PFPS is likely on the same spectrum, the investigators propose a trial for therapy-resistant PFPS.

Hyaluronic acid is a naturally occurring molecule found in the synovial fluid of freely movable joints (such as the knee). It is believed to contribute to lubrication and cushioning in these joints. The composition of synovial fluid within arthritic joints is altered, resulting in reduced fluid viscosity and elasticity. One modern formulation of hyaluronic acid is Hylan G-F 20 (Synvisc-One, Sanofi Canada). This treatment is offered as a single injection and will be utilized in this clinical trial.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Reed Ferber
  • Phone Number: 403-210-6468

Study Locations

  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T3E2K3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Adults aged 18-45
  2. Previously diagnosed with PFPS that failed to improve with at least 6 weeks of active rehabilitation, supervised by physiotherapist.
  3. Retropatellar or peripatellar knee pain for a minimum of 2 months
  4. Pain aggravated by at least two of the following patellofemoral joint loading activities: squatting, running, ascending or descending stairs, or sitting with prolonged knee flexion
  5. Pain with patellar grind test on clinical examination
  6. Visual Analog Scale (VAS) > 4/10 with patellofemoral joint loading activities
  7. Normal knee x-ray

Exclusion Criteria:

  1. X-ray evidence of osteoarthritis or fracture
  2. Meniscal or ligamentous injury suspected clinical examination
  3. Previous knee surgery
  4. History of patellar instability or positive patellar apprehension test
  5. Any contraindication to knee injection (overlying skin or joint infection, joint effusion, coagulopathy, previous adverse reaction etc.)
  6. Known allergy to avian products
  7. Previous knee injection within the last 3 months
  8. Pregnant or breastfeeding

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Immediate-start group
Hylan G-F 20 6 mL intra-articular knee injection
Device: Hylan G-F 20
Intra-articular injection of 6 mL Hylan G-F 20
Other Names:
  • Synvisc-One
Other: Delayed-start group
Washout control group which then becomes an experimental group (Hylan G-F 20 6 mL intra-articular knee injection) at 6 weeks post-enrolment
Device: Hylan G-F 20
Intra-articular injection of 6 mL Hylan G-F 20
Other Names:
  • Synvisc-One

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Pain measured using the visual analog scale (VAS)
Time Frame: 6 weeks
6 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Function measured using the Anterior Knee Pain Scale (AKPS)
Time Frame: 6 weeks and 12 weeks
6 weeks and 12 weeks
Pain measured using the visual analog scale (VAS)
Time Frame: Weekly until 12 weeks post injection
Weekly until 12 weeks post injection
Kinetic and kinematic data
Time Frame: Baseline compared to 6 weeks post injection
Data will be collected using a 3-D motion analysis system with 8 cameras and an instrumented treadmill
Baseline compared to 6 weeks post injection

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Calgary

Investigators

  • Principal Investigator: Jordan Raugust, University of Calgary
  • Study Director: Andrew Malawski, University of Calgary
  • Study Chair: Reed Ferber, University of Calgary

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2016

Primary Completion (Anticipated)

December 1, 2017

Study Completion (Anticipated)

December 1, 2017

Study Registration Dates

First Submitted

November 20, 2015

First Submitted That Met QC Criteria

November 23, 2015

First Posted (Estimate)

November 24, 2015

Study Record Updates

Last Update Posted (Estimate)

November 8, 2016

Last Update Submitted That Met QC Criteria

November 6, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VIP-123

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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