Recruiting
Phase 2

Hyaluronic Acid

Sponsor:

University of Calgary

Code:

NCT02613247

Conditions

Patellofemoral Pain Syndrome

Eligibility Criteria

Sex: All

Age: 18 - 45

Healthy Volunteers: Not accepted

Interventions

Hylan G-F 20

Study Details

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

Study ID

NCT02613247

Start date

Mar, 2016

Status verified date

Nov, 2016

Completion date

Dec, 2017

Anticipated

Primary completion date

Dec, 2017

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 45

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

50 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Immediate-start group

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

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

Interventions

Hylan G-F 20

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

Primary outcome measure

  • Pain measured using the visual analog scale (VAS) [ Time Frame: 6 weeks ]

Central Contacts and Locations

Central contacts

Locations

Calgary Running Injury Clinic

Recruiting

Calgary, Alberta, Canada, T3E2K3

Contacts

More Information

Sponsor

University of Calgary

Last update posted

Nov 8, 2016

Last verified

Nov, 2016

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Calgary on 2016-11-08.