Patellofemoral Pain SyndromePhase 2NCT02613247
Intra-articular Hyaluronic Acid Injection for Therapy-resistant Patellofemoral Pain Syndrome
A Phase 2 study testing Hylan G-F 20 in people with Patellofemoral Pain Syndrome, run by University of Calgary at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Patellofemoral Pain Syndrome
- What is being tested?
- Hylan G-F 20
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteCanada
- Study dates
- Mar 2016to Dec 2017
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Reed Ferber contact
Canada1 site, 1 recruiting
- Recruiting
Calgary Running Injury Clinic
Calgary, Alberta, T3E2K3
Jordan Raugust, 403-460-5642, info@runninginjuryclinic.com
About this study
Official title: Intra-articular Hyaluronic Acid Injection for Therapy-resistant Patellofemoral Pain Syndrome: an Open-label, Randomized, Delayed-start Clinical Trial
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
- Being tested
- Hylan G-F 20
- Keywords
- Viscosupplementation, Hyaluronic acid, Synvisc, Synvisc-One, Patellofemoral pain syndrome, PFPS, Anterior knee pain, Runner's knee
- Medical subject headings
- Patellofemoral Pain Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hylan G-F 20Device
Also called Synvisc-One
Intra-articular injection of 6 mL Hylan G-F 20
| Study group | Role | What they receive |
|---|---|---|
| Immediate-start group | Experimental | Hylan G-F 20 6 mL intra-articular knee injection Receives: 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 Receives: Device: Hylan G-F 20 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain measured using the visual analog scale (VAS)
Measured: 6 weeks
Secondary outcomes (3)
Function measured using the Anterior Knee Pain Scale (AKPS)
Measured: 6 weeks and 12 weeks
Pain measured using the visual analog scale (VAS)
Measured: Weekly until 12 weeks post injection
Kinetic and kinematic data
Data will be collected using a 3-D motion analysis system with 8 cameras and an instrumented treadmill
Measured: Baseline compared to 6 weeks post injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2015 (estimated)
- Study startMar 2016
- Primary completionDec 2017 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patellofemoral Pain SyndromeStudies of the same condition, open and under way.
- More trials run by University of CalgaryThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Calgary
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jordan Raugust, University of Calgary
- Investigators
- Jordan Raugust, Principal investigator, University of CalgaryAndrew Malawski, Study director, University of CalgaryReed Ferber, Study chair, University of Calgary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02613247
- Sponsor's protocol ID
- VIP-123
- Status last verified
- Nov 2016
- First submitted
- 20 Nov 2015
- Last updated
- 8 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intra-articular Hyaluronic Acid Injection for Therapy-resistant Patellofemoral Pain Syndrome: an Open-label, Randomized, Delayed-start Clinical Trial
- ClinicalTrials.gov ID
- NCT02613247
- Acronym / sponsor ID
- VIP-123
- Conditions
- Patellofemoral Pain Syndrome
- Keywords
- Viscosupplementation, Hyaluronic acid, Synvisc, Synvisc-One, Patellofemoral pain syndrome, PFPS, Anterior knee pain, Runner's knee
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of CalgaryUniversity, hospital or other
- Study start
- Mar 2016
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 24 Nov 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Immediate-start group | Experimental | Device: Hylan G-F 20Hylan G-F 20 6 mL intra-articular knee injection |
| Delayed-start group | Other | Device: Hylan G-F 20Washout control group which then becomes an experimental group (Hylan G-F 20 6 mL intra-articular knee injection) at 6 weeks post-enrolment |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (8 listed)
- 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.)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hylan G-F 20Also: Synvisc-OneIntra-articular injection of 6 mL Hylan G-F 20 | Device | Delayed-start group, Immediate-start group |
Primary outcome
Pain measured using the visual analog scale (VAS)
Time frame: 6 weeks
3 secondary outcomes
Function measured using the Anterior Knee Pain Scale (AKPS)
Time frame: 6 weeks and 12 weeks
Pain measured using the visual analog scale (VAS)
Time frame: Weekly until 12 weeks post injection
Kinetic and kinematic data
Time frame: Baseline compared to 6 weeks post injection
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Reed Ferber contact
Jordan Raugust principal investigator
University of Calgary
Andrew Malawski study director
University of Calgary
Reed Ferber study chair
University of Calgary
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Hylan G-F 20 in people with Patellofemoral Pain Syndrome, run by University of Calgary at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jordan Raugust (403-251-1165, info@kinesis.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain measured using the visual analog scale (VAS) (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2016.