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

Primary Purpose

Patellofemoral Pain Syndrome

Status
Unknown status
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
Hylan G-F 20
Sponsored by
University of Calgary
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Patellofemoral Pain Syndrome focused on measuring Viscosupplementation, Hyaluronic acid, Synvisc, Synvisc-One, Patellofemoral pain syndrome, PFPS, Anterior knee pain, Runner's knee

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Calgary Running Injury ClinicRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Immediate-start group

Delayed-start group

Arm Description

Hylan G-F 20 6 mL intra-articular knee injection

Washout control group which then becomes an experimental group (Hylan G-F 20 6 mL intra-articular knee injection) at 6 weeks post-enrolment

Outcomes

Primary Outcome Measures

Pain measured using the visual analog scale (VAS)

Secondary Outcome Measures

Function measured using the Anterior Knee Pain Scale (AKPS)
Pain measured using the visual analog scale (VAS)
Kinetic and kinematic data
Data will be collected using a 3-D motion analysis system with 8 cameras and an instrumented treadmill

Full Information

First Posted
November 20, 2015
Last Updated
November 6, 2016
Sponsor
University of Calgary
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1. Study Identification

Unique Protocol Identification Number
NCT02613247
Brief Title
Intra-articular Hyaluronic Acid Injection for Therapy-resistant Patellofemoral Pain Syndrome
Official Title
Intra-articular Hyaluronic Acid Injection for Therapy-resistant Patellofemoral Pain Syndrome: an Open-label, Randomized, Delayed-start Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
November 2016
Overall Recruitment Status
Unknown status
Study Start Date
March 2016 (undefined)
Primary Completion Date
December 2017 (Anticipated)
Study Completion Date
December 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Calgary

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Patellofemoral Pain Syndrome
Keywords
Viscosupplementation, Hyaluronic acid, Synvisc, Synvisc-One, Patellofemoral pain syndrome, PFPS, Anterior knee pain, Runner's knee

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Immediate-start group
Arm Type
Experimental
Arm Description
Hylan G-F 20 6 mL intra-articular knee injection
Arm Title
Delayed-start group
Arm Type
Other
Arm Description
Washout control group which then becomes an experimental group (Hylan G-F 20 6 mL intra-articular knee injection) at 6 weeks post-enrolment
Intervention Type
Device
Intervention Name(s)
Hylan G-F 20
Other Intervention Name(s)
Synvisc-One
Intervention Description
Intra-articular injection of 6 mL Hylan G-F 20
Primary Outcome Measure Information:
Title
Pain measured using the visual analog scale (VAS)
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Function measured using the Anterior Knee Pain Scale (AKPS)
Time Frame
6 weeks and 12 weeks
Title
Pain measured using the visual analog scale (VAS)
Time Frame
Weekly until 12 weeks post injection
Title
Kinetic and kinematic data
Description
Data will be collected using a 3-D motion analysis system with 8 cameras and an instrumented treadmill
Time Frame
Baseline compared to 6 weeks post injection

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Adults aged 18-45 Previously diagnosed with PFPS that failed to improve with at least 6 weeks of active rehabilitation, supervised by physiotherapist. Retropatellar or peripatellar knee pain for a minimum of 2 months 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 Pain with patellar grind test on clinical examination Visual Analog Scale (VAS) > 4/10 with patellofemoral joint loading activities Normal knee x-ray Exclusion Criteria: X-ray evidence of osteoarthritis or fracture Meniscal or ligamentous injury suspected clinical examination Previous knee surgery History of patellar instability or positive patellar apprehension test Any contraindication to knee injection (overlying skin or joint infection, joint effusion, coagulopathy, previous adverse reaction etc.) Known allergy to avian products Previous knee injection within the last 3 months Pregnant or breastfeeding
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jordan Raugust
Phone
403-251-1165
Email
info@kinesis.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Reed Ferber
Phone
403-210-6468
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jordan Raugust
Organizational Affiliation
University of Calgary
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Andrew Malawski
Organizational Affiliation
University of Calgary
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Reed Ferber
Organizational Affiliation
University of Calgary
Official's Role
Study Chair
Facility Information:
Facility Name
Calgary Running Injury Clinic
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T3E2K3
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jordan Raugust
Phone
403-460-5642
Email
info@runninginjuryclinic.com

12. IPD Sharing Statement

Learn more about this trial

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

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