A Randomized Double-Blind Placebo Controlled Trial to Determine the Status of Post Knee Chondroplasty Patients Administered Theramine Versus Placebo in Addition to Post Surgery Analgesics
Men and non-pregnant, non-lactating women over the age of 18 and under the age of 75, able to read, understand and sign English-language informed consent.
If using psychoactive medication which might have analgesic effects, (i.e. anti-depressants or anti-consultants), treatment must be stable for at least three (3) months prior to study.
For men and women of child-bearing potential, must be willing to use adequate contraception and not be pregnant or impregnate their partner during the entire time of study.
Must be willing to commit to all clinical visits during study-related procedures.
Require use of narcotics for pain relief.
You may not be if
Patients with significant neurologic impairment, as diagnosed on screening physical examination.
Patients not fluent in English.
Patients currently involved in a Workman's Compensation case related to this procedure.
Receipt of an oral intramuscular or soft-tissue injection of corticosteroid within one (1) month prior to screening.
History of substance abuse.
History of malignancy, other than basal or squamous cell of the skin within the last 5 years.
Tibial plateau fracture within 6 months prior to surgery.
Clareo Health | A Randomized Double-Blind Placebo Controlled Trial to Determine the Status of Post Knee Chondroplasty Patients Administered Theramine Versus Placebo in Addition to Post Surgery Analgesics