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

Sponsor

University of Calgary (Other)

Overall Status

Unknown status

CT.gov ID

NCT02613247

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

2.4

Patients Per Site Per Month

Study Details

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.

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

Study Design

Study Type:

Interventional

Anticipated 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 :

Mar 1, 2016

Anticipated Primary Completion Date :

Dec 1, 2017

Anticipated Study Completion Date :

Dec 1, 2017

Arms and Interventions

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 Names: Synvisc-One
Other: 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 Names: Synvisc-One

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 Names:

Synvisc-One

Other: 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 Names:

Synvisc-One

Outcome Measures

Primary Outcome Measures

Pain measured using the visual analog scale (VAS) [6 weeks]

Secondary Outcome Measures

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 data [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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 45 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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