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Clinical Trial Summary

All subjects will receive three, single-sided injections of PLLA, performed 1 month apart.


Clinical Trial Description

Enrolled subjects will be randomized to 2 treatment groups: "Right side treated" and "Left side treated". All subjects will receive three, single-sided injections of PLLA, performed 1 month apart. Treatments will be provided to one randomly assigned knee. The non-treatment knee will receive bacteriostatic water, injected in the same manner as PLLA. Up to one (1) syringe of PLLA, diluted at 16 mL, will be used per session.

Subjects satisfying all inclusion and exclusion criteria will be enrolled in this trial. Prior to receiving any study treatment, mandatory photography using 2D photography and Vectra will be obtained of each subject's treatment area. All photographs may be used for research and/or commercial use. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03487172
Study type Interventional
Source Goldman, Butterwick, Fitzpatrick and Groff
Contact
Status Completed
Phase N/A
Start date April 10, 2018
Completion date April 17, 2019

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