Effectiveness Trial for Evaluating IAHA for PFPS

NCT ID: NCT01811654

Last Updated: 2020-02-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-04-30
• Study Completion Date: 2017-03-04

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.

Conditions

Patellofemoral Pain Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

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.

Group Type: ACTIVE_COMPARATOR

Intra-Articular Hyaluronic Acid-Euflexxa

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

Other Intervention Names

Intra-articular Hyaluronan; IAHA; Viscosupplementation

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ferring Pharmaceuticals

INDUSTRY

Sponsor Role: collaborator

NYU Langone Health

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Dennis Cardone, DO

Role: PRINCIPAL_INVESTIGATOR

NYU Langone Medical Center

Philip Band, PhD

Role: STUDY_DIRECTOR

NYU Langone Medical Center/Hospital for Joint Disease

Locations

Center for Musculoskeletal Care - NYU Langone Medical Center

New York, New York, United States

Countries

United States

Other Identifiers

11-01020

Identifier Type: -

Identifier Source: org_study_id