Effectiveness Trial for Evaluating IAHA for PFPS

NCT01811654 | Completed Results DMC FDA Device

• 1 other identifier: 11-01020
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Patellofemoral Pain Syndrome

Keywords

Patellofemoral; Hyaluronan; Intra-articular; Hyaluronic acid

Outcome Measures

Primary Outcomes (1)

• 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.

  At baseline and 3 month follow-up

Secondary Outcomes (1)

• PFPS Severity Scale (PSS) Score

  3 month follow-up

Study Arms (2)

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.

Device: Intra-Articular Hyaluronic Acid-Euflexxa

Interventions

Intra-Articular Hyaluronic Acid-Euflexxa DEVICE

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.

Also known as: Intra-articular Hyaluronan, IAHA, Viscosupplementation

Intra-Articular Hyaluronic Acid-Euflexxa

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• NYU Langone Health: lead
• Ferring Pharmaceuticals: collaborator

Study Sites (1)

Center for Musculoskeletal Care - NYU Langone Medical Center

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

Patellofemoral Pain Syndrome

Interventions

Viscosupplementation

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Injections, Intra-Articular; Injections; Drug Administration Routes; Drug Therapy; Therapeutics; Orthopedic Procedures

Results Point of Contact

• Title: Dennis Cardone, DO
• Organization: NYU Langone Health

ariel.aponte@nyumc.org

212-460-0176

Study Officials

• Dennis Cardone, DO

  NYU Langone Medical Center

  PRINCIPAL INVESTIGATOR

• Philip Band, PhD

  NYU Langone Medical Center/Hospital for Joint Disease

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 15, 2013
• First Posted: March 14, 2013
• Study Start: April 1, 2013
• Primary Completion: December 7, 2016
• Study Completion: March 4, 2017
• Last Updated: February 26, 2020
• Results First Posted: February 13, 2020

Record last verified: 2020-02

Locations

US (1)