N/A
N=30
Effectiveness Trial for Evaluating IAHA for PFPS
Patellofemoral Pain Syndrome
Bottom Line
View on ClinicalTrials.gov: NCT01811654 ↗Enrolled (actual)
30
Serious AEs
0.0%
Results posted
Feb 2020
Primary outcome: Primary: Change in Visual Analog Scale (VAS) Score — 70; 62.23; 37.61; 25.025 millimeters
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Intra-Articular Hyaluronic Acid-Euflexxa (Device)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- NYU Langone Health
- Primary completion
- Dec 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Visual Analog Scale (VAS) Score |
70; 62.23; 37.61; 25.025 | — |
| SECONDARY PFPS Severity Scale (PSS) Score |
5; 5.21; 5.5; 4.42; 3.5; 3.64 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT01811654). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.