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

NCT02613247 | Unknown Phase 2

• 1 other identifier: VIP-123
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Patellofemoral Pain Syndrome

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Pain measured using the visual analog scale (VAS)

  6 weeks

Secondary Outcomes (3)

• 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

Study Arms (2)

Immediate-start group

EXPERIMENTAL

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

Device: Hylan G-F 20

Delayed-start group

OTHER

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

Interventions

Hylan G-F 20 DEVICE

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

Also known as: Synvisc-One

Delayed-start group; Immediate-start group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Calgary: lead

Study Sites (1)

Calgary Running Injury Clinic

Calgary, Alberta, T3E2K3, Canada

RECRUITING

MeSH Terms

Conditions

Patellofemoral Pain Syndrome

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases

Study Officials

• Jordan Raugust

  University of Calgary

  PRINCIPAL INVESTIGATOR

• Andrew Malawski

  University of Calgary

  STUDY DIRECTOR

• Reed Ferber

  University of Calgary

  STUDY CHAIR

Central Study Contacts

Jordan Raugust

CONTACT

403-251-1165; info@kinesis.ca

Reed Ferber

CONTACT

403-210-6468

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 20, 2015
• First Posted: November 24, 2015
• Study Start: March 1, 2016
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: November 8, 2016

Record last verified: 2016-11

Locations

CA (1)