Effectiveness Trial for Evaluating IAHA for PFPS

Not Applicable

Completed

Conditions: Patellofemoral Pain Syndrome

Interventions: Device: Intra-Articular Hyaluronic Acid-Euflexxa

Registration Number: NCT01811654

Lead Sponsor: NYU Langone Health

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 30

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intra-Articular Hyaluronic Acid-Euflexxa	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.

Primary Outcome Measures

Name	Time	Method
Change in Visual Analog Scale (VAS) Score	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.

Secondary Outcome Measures

Name	Time	Method
PFPS Severity Scale (PSS) Score	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."