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Effectiveness Trial for Evaluating IAHA for PFPS (PFPS)

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ClinicalTrials.gov Identifier: NCT01811654
Recruitment Status : Completed
First Posted : March 14, 2013
Results First Posted : February 13, 2020
Last Update Posted : February 26, 2020
Sponsor:
Collaborator:
Ferring Pharmaceuticals
Information provided by (Responsible Party):
NYU Langone Health

Tracking Information
First Submitted Date  ICMJE February 15, 2013
First Posted Date  ICMJE March 14, 2013
Results First Submitted Date  ICMJE February 8, 2019
Results First Posted Date  ICMJE February 13, 2020
Last Update Posted Date February 26, 2020
Actual Study Start Date  ICMJE April 2013
Actual Primary Completion Date December 7, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 11, 2020)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: March 12, 2013)
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 History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 12, 2020)
PFPS Severity Scale (PSS) Score [ Time Frame: 3 month follow-up ]
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."
Original Secondary Outcome Measures  ICMJE
 (submitted: March 12, 2013)
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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures
 (submitted: March 12, 2013)
  • 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
 
Descriptive Information
Brief Title  ICMJE Effectiveness Trial for Evaluating IAHA for PFPS
Official Title  ICMJE A Randomized, Pragmatic, Effectiveness Trial Evaluating Intra-articular Hyaluronan for the Symptomatic Treatment of Chronic Patellofemoral Pain Syndrome
Brief 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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Patellofemoral Pain Syndrome
Intervention  ICMJE 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.
Other Names:
  • Intra-articular Hyaluronan
  • IAHA
  • Viscosupplementation
Study Arms  ICMJE
  • 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.
    Intervention: Device: Intra-Articular Hyaluronic Acid-Euflexxa
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 18, 2018)
30
Original Estimated Enrollment  ICMJE
 (submitted: March 12, 2013)
68
Actual Study Completion Date  ICMJE March 4, 2017
Actual Primary Completion Date December 7, 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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:

    • Going up or down stairs
    • Squatting
    • Running
    • Hopping or jumping
    • Kneeling
    • Prolonged sitting
  • A baseline activity related VAS pain score between 50 and 90

Exclusion Criteria:

  • 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
    • 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 40 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01811654
Other Study ID Numbers  ICMJE 11-01020
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
IPD Sharing Statement  ICMJE Not Provided
Responsible Party NYU Langone Health
Study Sponsor  ICMJE NYU Langone Health
Collaborators  ICMJE Ferring Pharmaceuticals
Investigators  ICMJE
Principal Investigator: Dennis Cardone, DO NYU Langone Medical Center
Study Director: Philip Band, PhD NYU Langone Medical Center/Hospital for Joint Disease
PRS Account NYU Langone Health
Verification Date February 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP