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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

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Patellofemoral Pain Syndrome
Intervention Device: Intra-Articular Hyaluronic Acid-Euflexxa
Enrollment 30
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Standard Care Intra-Articular Hyaluronic Acid-Euflexxa
Hide Arm/Group Description 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.

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.

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.

Period Title: Overall Study
Started 14 16
Completed 14 16
Not Completed 0 0
Arm/Group Title Intra-Articular Hyaluronic Acid-Euflexxa Standard Care Total
Hide Arm/Group Description 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. 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. Total of all reporting groups
Overall Number of Baseline Participants 16 14 30
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants 14 participants 30 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
16
 100.0%
14
 100.0%
30
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants 14 participants 30 participants
Female
8
  50.0%
7
  50.0%
15
  50.0%
Male
8
  50.0%
7
  50.0%
15
  50.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 16 participants 14 participants 30 participants
16 14 30
1.Primary Outcome
Title Change in Visual Analog Scale (VAS) Score
Hide Description 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.
Time Frame At baseline and 3 month follow-up
Hide Outcome Measure Data
Hide Analysis Population Description
Both " Overall Number of Participants Analyzed" and "Participant Flow" are now consistent
Arm/Group Title Standard Care Intra-Articular Hyaluronic Acid-Euflexxa
Hide Arm/Group Description:
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.

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.

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.

Overall Number of Participants Analyzed 14 16
Mean (Standard Deviation)
Unit of Measure: millimeters
Baseline 70  (13.59) 62.23  (15.48)
3 Months 37.61  (31.40) 25.025  (15.5)
2.Secondary Outcome
Title PFPS Severity Scale (PSS) Score
Hide Description 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."
Time Frame 3 month follow-up
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Standard Care Intra-Articular Hyaluronic Acid-Euflexxa
Hide Arm/Group Description:
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.

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.

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.

Overall Number of Participants Analyzed 14 16
Mean (Standard Deviation)
Unit of Measure: score on a scale
Climbing stairs 5  (2.44) 5.21  (2.32)
squatting 5.5  (3.46) 4.42  (3.77)
walking 3.5  (2.22) 3.64  (2.37)
Jogging 3.87  (4.08) 3.42  (3.56)
Running 3.75  (4.37) 4.07  (4.08)
sport 2.06  (3.76) 3.64  (3.95)
sitting with bent 5.81  (2.71) 4.35  (2.92)
kneeling 4.56  (3.66) 5.21  (2.51)
pain at rest 4.06  (2.54) 2.57  (2.10)
following activities 4.75  (3.06) 4.42  (2.62)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Standard Care Intra-Articular Hyaluronic Acid-Euflexxa
Hide Arm/Group Description 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.

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.

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.

All-Cause Mortality
Standard Care Intra-Articular Hyaluronic Acid-Euflexxa
Affected / at Risk (%) Affected / at Risk (%)
Total   0/14 (0.00%)   0/16 (0.00%) 
Hide Serious Adverse Events
Standard Care Intra-Articular Hyaluronic Acid-Euflexxa
Affected / at Risk (%) Affected / at Risk (%)
Total   0/14 (0.00%)   0/16 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Standard Care Intra-Articular Hyaluronic Acid-Euflexxa
Affected / at Risk (%) Affected / at Risk (%)
Total   0/14 (0.00%)   0/16 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dennis Cardone, DO
Organization: NYU Langone Health
Phone: 212-460-0176
EMail: ariel.aponte@nyumc.org
Layout table for additonal information
Responsible Party: NYU Langone Health
ClinicalTrials.gov Identifier: NCT01811654    
Other Study ID Numbers: 11-01020
First Submitted: February 15, 2013
First Posted: March 14, 2013
Results First Submitted: February 8, 2019
Results First Posted: February 13, 2020
Last Update Posted: February 26, 2020