Effectiveness Trial for Evaluating IAHA for PFPS (PFPS)
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|ClinicalTrials.gov Identifier: NCT01811654|
Recruitment Status : Completed
First Posted : March 14, 2013
Last Update Posted : January 23, 2018
|Condition or disease||Intervention/treatment||Phase|
|Patellofemoral Pain Syndrome||Device: Intra-Articular Hyaluronic Acid-Euflexxa||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Randomized, Pragmatic, Effectiveness Trial Evaluating Intra-articular Hyaluronan for the Symptomatic Treatment of Chronic Patellofemoral Pain Syndrome|
|Study Start Date :||April 2013|
|Actual Primary Completion Date :||December 7, 2016|
|Actual Study Completion Date :||March 4, 2017|
No Intervention: Standard Care
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.
Active Comparator: Intra-Articular Hyaluronic Acid-Euflexxa
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.
Device: Intra-Articular Hyaluronic Acid-Euflexxa
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.
- 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
- Change in PFPS Severity Scale (PSS) score [ Time Frame: At baseline and 3 month follow-up ]The PSS was specifically designed and tested on patients suffering from patellofemoral pain syndrome. In its original form, it is a visual analog scale (100 mm) for pain while performing 10 different activities that reflect typically painful movements for physically active subjects with PFPS. For the purposes of this study, the PSS was modified from a 10 cm visual analog scale to a 10 point Likert scale. This modified PSS will be used by all subjects. In addition, patients will be asked to identify which activity within the PSS is most painful to them.
- Change in Tegner Activity Scale score [ Time Frame: At baseline and 3 month follow-up ]The Tegner activity scale will be used as an additional secondary outcome measure in this study because it has been demonstrated to be a valid clinimetric instrument for assessing function in patients with knee pain. The Tegner activity scale uses a numerical scale ranging from 0 to 10. Each value indicates the ability to perform specific activities. An activity level of 10 corresponds to participation in competitive sports, including soccer, football, and rugby at the elite level. Whereas an activity level of 0 is assigned if a person is on sick leave or receiving a disability pension because of knee problems.
- Global Assessment [ Time Frame: At 3 month follow-up ]A global assessment tool (e.g. EQ-5D) will be administered during the final visit for this study
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01811654
|United States, New York|
|Center for Musculoskeletal Care - NYU Langone Medical Center|
|New York, New York, United States, 10016|
|Principal Investigator:||Dennis Cardone, DO||NYU Langone Medical Center|
|Study Director:||Philip Band, PhD||NYU Langone Medical Center/Hospital for Joint Disease|