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

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

Status
UNKNOWN
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02613247
Enrollment
50
Registered
2015-11-24
Start date
2016-03-31
Completion date
2017-12-31
Last updated
2016-11-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patellofemoral Pain Syndrome

Keywords

Viscosupplementation, Hyaluronic acid, Synvisc, Synvisc-One, Patellofemoral pain syndrome, PFPS, Anterior knee pain, Runner's knee

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.

Interventions

Intra-articular injection of 6 mL Hylan G-F 20

Sponsors

University of Calgary
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Pain measured using the visual analog scale (VAS)6 weeks

Secondary

MeasureTime frameDescription
Function measured using the Anterior Knee Pain Scale (AKPS)6 weeks and 12 weeks
Pain measured using the visual analog scale (VAS)Weekly until 12 weeks post injection
Kinetic and kinematic dataBaseline compared to 6 weeks post injectionData will be collected using a 3-D motion analysis system with 8 cameras and an instrumented treadmill

Countries

Canada

Contacts

Primary ContactJordan Raugust
info@kinesis.ca403-251-1165
Backup ContactReed Ferber
403-210-6468

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026