Patellofemoral Pain Syndrome
Conditions
Keywords
Patellofemoral, Hyaluronan, Intra-articular, Hyaluronic acid
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.
Interventions
DEVICEIntra-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.
Sponsors
Ferring Pharmaceuticals
NYU Langone Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 16 |
| 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. | 14 |
| Total | 30 |
Baseline characteristics
| Characteristic | Intra-Articular Hyaluronic Acid-Euflexxa | Standard Care | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 16 Participants | 14 Participants | 30 Participants |
| Region of Enrollment United States | 16 participants | 14 participants | 30 participants |
| Sex: Female, Male Female | 8 Participants | 7 Participants | 15 Participants |
| Sex: Female, Male Male | 8 Participants | 7 Participants | 15 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 14 | 0 / 16 |
| other Total, other adverse events | 0 / 14 | 0 / 16 |
| serious Total, serious adverse events | 0 / 14 | 0 / 16 |
Outcome results
Primary
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.
Time frame: At baseline and 3 month follow-up
Population: Both Overall Number of Participants Analyzed and Participant Flow are now consistent
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Standard Care | Change in Visual Analog Scale (VAS) Score | Baseline | 70 millimeters | Standard Deviation 13.59 |
| Standard Care | Change in Visual Analog Scale (VAS) Score | 3 Months | 37.61 millimeters | Standard Deviation 31.4 |
| Intra-Articular Hyaluronic Acid-Euflexxa | Change in Visual Analog Scale (VAS) Score | Baseline | 62.23 millimeters | Standard Deviation 15.48 |
| Intra-Articular Hyaluronic Acid-Euflexxa | Change in Visual Analog Scale (VAS) Score | 3 Months | 25.025 millimeters | Standard Deviation 15.5 |
Secondary
PFPS Severity Scale (PSS) Score
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Standard Care | PFPS Severity Scale (PSS) Score | sitting with bent | 5.81 score on a scale | Standard Deviation 2.71 |
| Standard Care | PFPS Severity Scale (PSS) Score | squatting | 5.5 score on a scale | Standard Deviation 3.46 |
| Standard Care | PFPS Severity Scale (PSS) Score | walking | 3.5 score on a scale | Standard Deviation 2.22 |
| Standard Care | PFPS Severity Scale (PSS) Score | Jogging | 3.87 score on a scale | Standard Deviation 4.08 |
| Standard Care | PFPS Severity Scale (PSS) Score | Running | 3.75 score on a scale | Standard Deviation 4.37 |
| Standard Care | PFPS Severity Scale (PSS) Score | sport | 2.06 score on a scale | Standard Deviation 3.76 |
| Standard Care | PFPS Severity Scale (PSS) Score | kneeling | 4.56 score on a scale | Standard Deviation 3.66 |
| Standard Care | PFPS Severity Scale (PSS) Score | pain at rest | 4.06 score on a scale | Standard Deviation 2.54 |
| Standard Care | PFPS Severity Scale (PSS) Score | following activities | 4.75 score on a scale | Standard Deviation 3.06 |
| Standard Care | PFPS Severity Scale (PSS) Score | Climbing stairs | 5 score on a scale | Standard Deviation 2.44 |
| Intra-Articular Hyaluronic Acid-Euflexxa | PFPS Severity Scale (PSS) Score | following activities | 4.42 score on a scale | Standard Deviation 2.62 |
| Intra-Articular Hyaluronic Acid-Euflexxa | PFPS Severity Scale (PSS) Score | Climbing stairs | 5.21 score on a scale | Standard Deviation 2.32 |
| Intra-Articular Hyaluronic Acid-Euflexxa | PFPS Severity Scale (PSS) Score | sport | 3.64 score on a scale | Standard Deviation 3.95 |
| Intra-Articular Hyaluronic Acid-Euflexxa | PFPS Severity Scale (PSS) Score | squatting | 4.42 score on a scale | Standard Deviation 3.77 |
| Intra-Articular Hyaluronic Acid-Euflexxa | PFPS Severity Scale (PSS) Score | sitting with bent | 4.35 score on a scale | Standard Deviation 2.92 |
| Intra-Articular Hyaluronic Acid-Euflexxa | PFPS Severity Scale (PSS) Score | walking | 3.64 score on a scale | Standard Deviation 2.37 |
| Intra-Articular Hyaluronic Acid-Euflexxa | PFPS Severity Scale (PSS) Score | pain at rest | 2.57 score on a scale | Standard Deviation 2.1 |
| Intra-Articular Hyaluronic Acid-Euflexxa | PFPS Severity Scale (PSS) Score | Jogging | 3.42 score on a scale | Standard Deviation 3.56 |
| Intra-Articular Hyaluronic Acid-Euflexxa | PFPS Severity Scale (PSS) Score | kneeling | 5.21 score on a scale | Standard Deviation 2.51 |
| Intra-Articular Hyaluronic Acid-Euflexxa | PFPS Severity Scale (PSS) Score | Running | 4.07 score on a scale | Standard Deviation 4.08 |