Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
No drug intervention. Study to collect 1 additional MRI of each knee treated in either TPX-100-1 or TPX-100-2.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Previous treated with TPX-100 | Other | No intervention, only observational |
|
| 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 |
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Subjects with bi-lateral knee OA that have previous been treated in TPX-100-1 or TPX-100-2
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dr. Samy Metyas | Covina | California | 91722 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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 |