A Prospective Observational Study to Evaluate Long-term Changes in Cartilage Morphology in Subjects Who Previously Received TPX-100 or Placebo in Study TPX-100-1 for Patellar Osteoarthritis Involving Both Knees
Completed
- Conditions
- Mild to Moderate Knee OA
- Registration Number
- NCT03125499
- Lead Sponsor
- OrthoTrophix, Inc
- Brief Summary
To evaluate the long-term changes in patellar cartilage thickness in TPX-100 versus placebo-treated knees in subjects who participated in Study TPX-100-1 or TPX-100-2.
- Detailed Description
No drug intervention. Study to collect 1 additional MRI of each knee treated in either TPX-100-1 or TPX-100-2.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 54
Inclusion Criteria
- Subjects who participated in TPX-100-1 and received 4 injections of 200 mg/injection TPX-100 in one knee, or subjects who participated in TPX-100
- Cruciate and collateral ligament stability as assessed by screening history and clinical examination
- Stable medial and lateral menisci as assessed by screening history and clinical examination
- Able to read, understand, sign and date the subject informed consent
Exclusion Criteria
- Contraindication to MRI, including: metallic fragments, clips or devices in the brain, eye, or spinal canal; implanted devices that are magnetically programmed; weight > 300 lbs.; moderate or severe claustrophobia; previous intolerance of MRI procedure
- Prior surgery in the knees, excluding procedures for debridement only (no previous microfracture procedure)
- History of rheumatoid arthritis, psoriatic arthritis, or any other autoimmune or infectious cause for arthritis
- Last viscosupplementation (e.g. Synvisc® or similar hyaluronic acid product) injected into either knee < 3 months before enrollment
- Last intra-articular knee injection of corticosteroids < 3 months before enrollment
- Use of any steroids (except inhaled corticosteroids for allergy or respiratory problems) during the previous month before enrollment
- History of arthroscopy in either knee in the 3 months before enrollment
- History of septic arthritis, gout or pseudo-gout in either knee in the 12 months before enrollment
- Clinical signs of acute meniscal tear (locking, new acute mechanical symptoms consistent with meniscal tear)
- Active systemic infection
- Participation in other clinical osteoarthritis drug studies, except for studies TPX-100-1 and TPX-100-2, within two years prior to enrollment in TPX-100-4.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Evaluate the long-term changes in patellar cartilage thickness Between 24 and 34 months from initial drug treatment Quantitative analysis of long-term changes in patellar cartilage thickness by MRI
- Secondary Outcome Measures
Name Time Method Examine intra-subject longitudinal changes in patellar cartilage volume between TPX-100 versus placebo-treated knees by MRI Between 24 and 34 months from initial drug treatment Examine intra-subject longitudinal changes in patellar cartilage volume between TPX-100 versus placebo-treated knees by MRI
Examine intra-subject longitudinal changes in thickness and thinness scores of cartilage in the central (non-patellar) compartment of knees Between 24 and 34 months from initial drug treatment Examine intra-subject longitudinal changes in thickness and thinness scores of cartilage in the central (non-patellar) compartment of knees
Examine intra-subject longitudinal changes in Patient reported outcome measures Between 24 and 34 months from initial drug treatment Examine intra-subject longitudinal changes in Patient Reported Outcome Measures
Trial Locations
- Locations (1)
Dr. Samy Metyas
🇺🇸Covina, California, United States