Patellofemoral Pain SyndromePFPSNCT01811654
Effectiveness Trial for Evaluating IAHA for PFPS
A study testing Intra-Articular Hyaluronic Acid-Euflexxa in people with Patellofemoral Pain Syndrome, run by NYU Langone Health at 1 site in United States.
Trial summary
The purpose of this study is to determine the safety and effectiveness of intra-articular hyaluronan (IAHA) injections for the treatment of symptomatic patellofemoral pain syndrome (PFPS) and determine if this treatment can provide incremental clinical benefits over standard care for patients with this diagnosis. Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Patellofemoral Pain Syndrome
- What is being tested?
- Intra-Articular Hyaluronic Acid-Euflexxa
- Type of treatment
- Pill or oral medicine, Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2013to 4 Mar 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Adults from the ages of 18-40, male or female
- Diagnosis of unilateral OR bilateral patellofemoral pain syndrome
- Duration of diagnosis no less than 2 months and no greater than 3 years in the study knee
- Unresponsive to standard treatment of at least 6 weeks duration, consisting of physical therapy, activity modification (relative rest), and/or oral analgesic therapy
- Insidious onset of symptoms unrelated to a traumatic incident
- Pain described as "behind", "underneath", or "around" the patella reported during at least two of the following activities:
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- Going up or down stairs
- Squatting
- Running
- Hopping or jumping
- Kneeling
- Prolonged sitting
- A baseline activity related VAS pain score between 50 and 90
Who cannot join
- Any co-morbidity that would influence the safety of intra-articular injections or impede safety and efficacy measurements in the study knee, such as:
- Coagulopathies or the use of anticoagulant medications
- History of allergy to any of the treatment interventions planned
- Acute inflammation and/or palpable effusion in the study knee
- Current or history of musculoskeletal infection in the study knee
- Severe malalignment, deformity or chronic subluxation of study knee
Show all 16Show fewer
- History of prior patellar dislocation of the study knee
- Ipsilateral joint/limb conditions (e.g. hip, thigh, lower leg, ankle, foot)
- Any condition other than PFPS in the contralateral knee present at the time of enrollment or developing during the course of enrollment
- Any radiographic signs of the following:
- Osteoarthritis in any of the study knee compartments
- Osteochondritis dissecans (OCD) lesions
- Physeal injuries
- Bone tumors
- Vulnerable subjects and pregnant women
- Participation in any other musculoskeletal studies
Trial locations and contacts
1 site in 1 country.
United States1 site
Center for Musculoskeletal Care - NYU Langone Medical Center
New York, New York, 10016
About this study
Official title: A Randomized, Pragmatic, Effectiveness Trial Evaluating Intra-articular Hyaluronan for the Symptomatic Treatment of Chronic Patellofemoral Pain Syndrome
The purpose of this study is to determine the safety and effectiveness of intra-articular hyaluronan (IAHA) injections for the treatment of symptomatic patellofemoral pain syndrome (PFPS) and determine if this treatment can provide incremental clinical benefits over standard care for patients with this diagnosis.
Read the detailed description
Objective: To determine the safety and effectiveness of intra-articular hyaluronan (IAHA) injections for the treatment of symptomatic patellofemoral pain syndrome (PFPS) and determine if this treatment can provide incremental clinical benefits over standard care for patients with this diagnosis.
Study Design: Two-arm, single-center, parallel, pragmatic, randomized, non-blinded, effectiveness trial
Indication for Use: For treatment of adult patients with Patellofemoral Pain Syndrome (PFPS) who have failed to respond to conservative treatment and simple analgesics (e.g. acetaminophen).
Setting: University Teaching Hospital, Faculty Practice
Subjects: Male and female patients aged 18-40 diagnosed with symptomatic patellofemoral pain syndrome (PFPS) that meet all inclusion and exclusion criteria. Approximately 68 subjects will be enrolled based on a power analysis of sample size estimation.
Methods: Patients signing informed consent will be randomized to one of two groups: (1) Standard Care, (2) Standard Care plus Intra-articular hyaluronan (IAHA) administered as a course of 3 consecutive weekly intra-articular injections.
Standard Care is defined as consisting of physical therapy, activity modification (relative rest), and/or oral analgesic therapy. Upon entering the trial, a specific physical therapy (PT) protocol will be implemented.
Data will be captured on the study knee history and symptoms. Radiographic examinations will be performed including weight-bearing anterior-posterior views with knees flexed 30 degrees, lateral, and sunrise views. The diagnosis of PFPS will be based on the subjects' being less than 40 years of age, and the occurrence of chronic retropatellar pain in the absence of other pain-causing abnormalities.
Arthrocentesis will be performed before all intra-articular injections, and any synovial fluid collected will be visually inspected for signs of infection before performing any injections. The volume of synovial fluid will be measured, and the samples will then be retained for further biomarker analysis.
A follow-up visit will be scheduled approximately 3 months after the baseline visit, to reevaluate patient condition.
Study Duration: A period of approximately 15 months is anticipated from the time the first patient is enrolled to the completion of the last patient visit. A final study report will then be generated after this 18 month time point.
- Conditions
- Patellofemoral Pain Syndrome
- Being tested
- Intra-Articular Hyaluronic Acid-Euflexxa
- Keywords
- Patellofemoral, Hyaluronan, Intra-articular, Hyaluronic acid
- 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.
Intra-Articular Hyaluronic Acid-EuflexxaDevice
Also called Intra-articular Hyaluronan, IAHA, Viscosupplementation
IAHA was approved by the FDA in 1997 as a synovial fluid replacement device to help relieve the pain associated with knee osteoarthritis (OA) in patients who fail to respond adequately to conservative treatment and simple analgesics. In this study, IAHA, specifically Euflexxa, will be used off-label to determine whether patients afflicted with PFPS will experience similar analgesic effects as seen in those with OA.
| Study group | Role | What they receive |
|---|---|---|
| Standard Care | No intervention | Patients in this group will receive treatment per standard care. Standard Care is defined as consisting of physical therapy, activity modification (relative rest), and/or oral analgesic therapy. A specific physical therapy (PT) protocol will be implemented. |
| Intra-Articular Hyaluronic Acid-Euflexxa | Active comparator | Patients assigned to this group will receive treatment per standard care AND three (3) consecutive weekly injections of intra-articular hyaluronan (Euflexxa). Oral analgesics will be used at the lowest dose and for the shortest time possible to treat PFPS symptoms. Receives: Device: Intra-Articular Hyaluronic Acid-Euflexxa |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Visual Analog Scale (VAS) Score
A 100mm visual analog scale (VAS) for activity related pain assessment will serve as the primary outcome measure. The 2-sample t-test comparing the two treatment groups' mean change from baseline issued. No pain (0-4 mm), mild pain(5-44 mm), moderate pain (45-74 mm), and severe pain (75-100 mm). The 2 sample t-test approximates the test of the null hypothesis that there is a difference in mean change from baseline in the VAS for activity-related pain between the HA group and control group. Higher scores indicate higher level of pain.
Measured: At baseline and 3 month follow-up
Secondary outcomes (1)
PFPS Severity Scale (PSS) Score
Encompasses 10 statements regarding PFPS pain. Severity scale consists of 10 statements, rated from "0" indicating "no pain" and a "10" indicating "pain as bad as it could be."
Measured: 3 month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2013 (estimated)
- Study startApr 2013
- Primary completion7 Dec 2016
- Study completion4 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Patellofemoral Pain SyndromeStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Collaborators
- Ferring Pharmaceuticals
- Responsible party
- Sponsor
- Investigators
- Dennis Cardone, DO, Principal investigator, NYU Langone Medical CenterPhilip Band, PhD, Study director, NYU Langone Medical Center/Hospital for Joint Disease
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01811654
- Sponsor's protocol ID
- 11-01020
- Acronym
- PFPS
- Status last verified
- Feb 2020
- First submitted
- 15 Feb 2013
- Last updated
- 26 Feb 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Pragmatic, Effectiveness Trial Evaluating Intra-articular Hyaluronan for the Symptomatic Treatment of Chronic Patellofemoral Pain Syndrome
- ClinicalTrials.gov ID
- NCT01811654
- Acronym / sponsor ID
- PFPS / 11-01020
- Conditions
- Patellofemoral Pain Syndrome
- Keywords
- Patellofemoral, Hyaluronan, Intra-articular, Hyaluronic acid
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Collaborators
- Ferring Pharmaceuticals
- Study start
- Apr 2013 (actual)
- Primary completion
- 7 Dec 2016 (actual)
- Study completion
- 4 Mar 2017 (actual)
- First posted
- 14 Mar 2013 (estimated)
- Results
- Posted 13 Feb 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine the safety and effectiveness of intra-articular hyaluronan (IAHA) injections for the treatment of symptomatic patellofemoral pain syndrome (PFPS) and determine if this treatment can provide incremental clinical benefits over standard care for patients with this diagnosis.
Detailed description
Objective: To determine the safety and effectiveness of intra-articular hyaluronan (IAHA) injections for the treatment of symptomatic patellofemoral pain syndrome (PFPS) and determine if this treatment can provide incremental clinical benefits over standard care for patients with this diagnosis.
Study Design: Two-arm, single-center, parallel, pragmatic, randomized, non-blinded, effectiveness trial
Indication for Use: For treatment of adult patients with Patellofemoral Pain Syndrome (PFPS) who have failed to respond to conservative treatment and simple analgesics (e.g. acetaminophen).
Setting: University Teaching Hospital, Faculty Practice
Subjects: Male and female patients aged 18-40 diagnosed with symptomatic patellofemoral pain syndrome (PFPS) that meet all inclusion and exclusion criteria. Approximately 68 subjects will be enrolled based on a power analysis of sample size estimation.
Methods: Patients signing informed consent will be randomized to one of two groups: (1) Standard Care, (2) Standard Care plus Intra-articular hyaluronan (IAHA) administered as a course of 3 consecutive weekly intra-articular injections.
Standard Care is defined as consisting of physical therapy, activity modification (relative rest), and/or oral analgesic therapy. Upon entering the trial, a specific physical therapy (PT) protocol will be implemented.
Data will be captured on the study knee history and symptoms. Radiographic examinations will be performed including weight-bearing anterior-posterior views with knees flexed 30 degrees, lateral, and sunrise views. The diagnosis of PFPS will be based on the subjects' being less than 40 years of age, and the occurrence of chronic retropatellar pain in the absence of other pain-causing abnormalities.
Arthrocentesis will be performed before all intra-articular injections, and any synovial fluid collected will be visually inspected for signs of infection before performing any injections. The volume of synovial fluid will be measured, and the samples will then be retained for further biomarker analysis.
A follow-up visit will be scheduled approximately 3 months after the baseline visit, to reevaluate patient condition.
Study Duration: A period of approximately 15 months is anticipated from the time the first patient is enrolled to the completion of the last patient visit. A final study report will then be generated after this 18 month time point.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Care | No intervention | –Patients in this group will receive treatment per standard care. Standard Care is defined as consisting of physical therapy, activity modification (relative rest), and/or oral analgesic therapy. A specific physical therapy (PT) protocol will be implemented. |
| Intra-Articular Hyaluronic Acid-Euflexxa | Active comparator | Device: Intra-Articular Hyaluronic Acid-EuflexxaPatients assigned to this group will receive treatment per standard care AND three (3) consecutive weekly injections of intra-articular hyaluronan (Euflexxa). Oral analgesics will be used at the lowest dose and for the shortest time possible to treat PFPS symptoms. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (13 listed)
- Adults from the ages of 18-40, male or female
- Diagnosis of unilateral OR bilateral patellofemoral pain syndrome
- Duration of diagnosis no less than 2 months and no greater than 3 years in the study knee
- Unresponsive to standard treatment of at least 6 weeks duration, consisting of physical therapy, activity modification (relative rest), and/or oral analgesic therapy
- Insidious onset of symptoms unrelated to a traumatic incident
Key exclusion criteria (16 listed)
- Any co-morbidity that would influence the safety of intra-articular injections or impede safety and efficacy measurements in the study knee, such as:
- Any condition other than PFPS in the contralateral knee present at the time of enrollment or developing during the course of enrollment
- Any radiographic signs of the following:
- Vulnerable subjects and pregnant women
- Participation in any other musculoskeletal studies
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 |
|---|---|---|
| Intra-Articular Hyaluronic Acid-EuflexxaAlso: Intra-articular Hyaluronan, IAHA, ViscosupplementationIAHA was approved by the FDA in 1997 as a synovial fluid replacement device to help relieve the pain associated with knee osteoarthritis (OA) in patients who fail to respond adequately to conservative treatment and simple analgesics. In this study, IAHA, specifically Euflexxa, will be used off-label to determine whether patients afflicted with PFPS will experience similar analgesic effects as seen in those with OA. | Device | Intra-Articular Hyaluronic Acid-Euflexxa |
Primary outcome
Change in Visual Analog Scale (VAS) Score
Time frame: At baseline and 3 month follow-up
A 100mm visual analog scale (VAS) for activity related pain assessment will serve as the primary outcome measure. The 2-sample t-test comparing the two treatment groups' mean change from baseline issued. No pain (0-4 mm), mild pain(5-44 mm), moderate pain (45-74 mm), and severe pain (75-100 mm). The 2 sample t-test approximates the test of the null hypothesis that there is a difference in mean change from baseline in the VAS for activity-related pain between the HA group and control group. Higher scores indicate higher level of pain.
1 secondary outcome
PFPS Severity Scale (PSS) Score
Time frame: 3 month follow-up
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Dennis Cardone, DO principal investigator
NYU Langone Medical Center
Philip Band, PhD study director
NYU Langone Medical Center/Hospital for Joint Disease
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intra-Articular Hyaluronic Acid-Euflexxa in people with Patellofemoral Pain Syndrome, run by NYU Langone Health at 1 site in United States.
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 13 inclusion and 16 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: finished, as of the sponsor's last update on 26 Feb 2020. 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 United States. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Feb 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Visual Analog Scale (VAS) Score (time frame: At baseline and 3 month follow-up). 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 26 Feb 2020.