Mild to Moderate Knee OA
Conditions
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.
Interventions
OTHERPrevious treated with TPX-100
No intervention, only observational
Sponsors
OrthoTrophix, Inc
Study design
Observational model
OTHER
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
25 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Outcome results
None listed