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
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
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
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
NCT ID
NCT02613247
First Posted
November 20, 2015
Last Updated
November 6, 2016
Sponsor
University of Calgary
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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