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

Study Overview
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Brief Summary
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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
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No drug intervention. Study to collect 1 additional MRI of each knee treated in either TPX-100-1 or TPX-100-2.

Official Title
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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

Conditions
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Mild to Moderate Knee OA

Intervention / Treatment
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* Other: Previous treated with TPX-100


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Previous treated with TPX-100|No intervention, only observational|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate the long-term changes in patellar cartilage thickness | Quantitative analysis of long-term changes in patellar cartilage thickness by MRI | Between 24 and 34 months from initial drug treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Examine intra-subject longitudinal changes in patellar cartilage volume between TPX-100 versus placebo-treated knees by MRI | 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 thickness and thinness scores of cartilage in the central (non-patellar) compartment of knees | 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 Patient reported outcome measures | Examine intra-subject longitudinal changes in Patient Reported Outcome Measures | Between 24 and 34 months from initial drug treatment |