Intra-articular Hyaluronic Acid Injection for Therapy-resistant Patellofemoral Pain Syndrome
NCT ID: NCT02613247
Last Updated: 2016-11-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
50 participants
INTERVENTIONAL
2016-03-31
2017-12-31
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Immediate-start group
Hylan G-F 20 6 mL intra-articular knee injection
Hylan G-F 20
Intra-articular injection of 6 mL Hylan G-F 20
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
Hylan G-F 20
Intra-articular injection of 6 mL Hylan G-F 20
Interventions
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Hylan G-F 20
Intra-articular injection of 6 mL Hylan G-F 20
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
45 Years
ALL
No
Sponsors
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University of Calgary
OTHER
Responsible Party
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Jordan Raugust
Principal Investigator
Principal Investigators
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Jordan Raugust
Role: PRINCIPAL_INVESTIGATOR
University of Calgary
Andrew Malawski
Role: STUDY_DIRECTOR
University of Calgary
Reed Ferber
Role: STUDY_CHAIR
University of Calgary
Locations
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Calgary Running Injury Clinic
Calgary, Alberta, Canada
Countries
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Central Contacts
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Reed Ferber
Role: CONTACT
Phone: 403-210-6468
Facility Contacts
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Jordan Raugust
Role: primary
Other Identifiers
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VIP-123
Identifier Type: -
Identifier Source: org_study_id