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Effectiveness Trial for Evaluating IAHA for PFPS

CompletedNot applicableNCT01811654
View the official record on ClinicalTrials.gov

Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.

This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.

Brief summary (from the registry)

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.

Study details

Official title
A Randomized, Pragmatic, Effectiveness Trial Evaluating Intra-articular Hyaluronan for the Symptomatic Treatment of Chronic Patellofemoral Pain Syndrome
Conditions
  • Patellofemoral Pain Syndrome
Interventions
  • Device: Intra-Articular Hyaluronic Acid-Euflexxa
Sponsor
NYU Langone Health
Collaborators
Ferring Pharmaceuticals
Start date
2013-04
Primary completion
2016-12-07
Sex
All
Age range
from 18 Years to 40 Years
Results posted
Yes, on ClinicalTrials.gov
Countries
United States
Total sites listed
1

Eligibility criteria

Show eligibility criteria (verbatim from the registry)
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

Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT01811654