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
| Status: | Terminated |
|---|---|
| Conditions: | Orthopedic |
| Therapuetic Areas: | Orthopedics / Podiatry |
| Healthy: | No |
| Age Range: | 18 - 65 |
| Updated: | 5/6/2016 |
| Start Date: | August 2012 |
| End Date: | December 2013 |
The purpose of this study will be to show the patient response to analgesics taken post
surgery when taken in combination with Theramine as opposed to Theramine-like placebo. The
data collected will be used to show that patients have a shorter and lower post operative
pain measurement and the time to discontinuation of analgesics is less in the active
comparator group.
surgery when taken in combination with Theramine as opposed to Theramine-like placebo. The
data collected will be used to show that patients have a shorter and lower post operative
pain measurement and the time to discontinuation of analgesics is less in the active
comparator group.
No other decription
Inclusion Criteria:
- Diagnosed knee pain requiring chondroplasty knee arthroscopic surgery.
- 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.
Exclusion Criteria:
- 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.
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