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

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ClinicalTrials.gov Identifier: NCT02613247
Recruitment Status : Unknown
Verified November 2016 by Jordan Raugust, University of Calgary.
Recruitment status was:  Recruiting
First Posted : November 24, 2015
Last Update Posted : November 8, 2016
Sponsor:
Information provided by (Responsible Party):
Jordan Raugust, University of Calgary

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Patellofemoral Pain Syndrome Device: Hylan G-F 20 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Intra-articular Hyaluronic Acid Injection for Therapy-resistant Patellofemoral Pain Syndrome: an Open-label, Randomized, Delayed-start Clinical Trial
Study Start Date : March 2016
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine


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 Name: Synvisc-One

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 Name: Synvisc-One




Primary Outcome Measures :
  1. Pain measured using the visual analog scale (VAS) [ Time Frame: 6 weeks ]

Secondary Outcome Measures :
  1. Function measured using the Anterior Knee Pain Scale (AKPS) [ Time Frame: 6 weeks and 12 weeks ]
  2. Pain measured using the visual analog scale (VAS) [ Time Frame: Weekly until 12 weeks post injection ]
  3. 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



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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02613247


Contacts
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Contact: Jordan Raugust 403-251-1165 info@kinesis.ca
Contact: Reed Ferber 403-210-6468

Locations
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Canada, Alberta
Calgary Running Injury Clinic Recruiting
Calgary, Alberta, Canada, T3E2K3
Contact: Jordan Raugust    403-460-5642    info@runninginjuryclinic.com   
Sponsors and Collaborators
University of Calgary
Investigators
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Principal Investigator: Jordan Raugust University of Calgary
Study Director: Andrew Malawski University of Calgary
Study Chair: Reed Ferber University of Calgary

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Responsible Party: Jordan Raugust, Principal Investigator, University of Calgary
ClinicalTrials.gov Identifier: NCT02613247     History of Changes
Other Study ID Numbers: VIP-123
First Posted: November 24, 2015    Key Record Dates
Last Update Posted: November 8, 2016
Last Verified: November 2016

Keywords provided by Jordan Raugust, University of Calgary:
Viscosupplementation
Hyaluronic acid
Synvisc
Synvisc-One
Patellofemoral pain syndrome
PFPS
Anterior knee pain
Runner's knee

Additional relevant MeSH terms:
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Syndrome
Somatoform Disorders
Patellofemoral Pain Syndrome
Disease
Pathologic Processes
Mental Disorders
Joint Diseases
Musculoskeletal Diseases
Hyaluronic Acid
Hylan
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Viscosupplements
Protective Agents