Status:
COMPLETED
Effectiveness Trial for Evaluating IAHA for PFPS
Lead Sponsor:
NYU Langone Health
Collaborating Sponsors:
Ferring Pharmaceuticals
Conditions:
Patellofemoral Pain Syndrome
Eligibility:
All Genders
18-40 years
Phase:
NA
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 determin...
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 treatmen...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 4 2017
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT01811654
Start Date
April 1 2013
End Date
March 4 2017
Last Update
February 26 2020
Active Locations (1)
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1
Center for Musculoskeletal Care - NYU Langone Medical Center
New York, New York, United States, 10016