Status:
TERMINATED
TRAUMEEL for Pain After Total Knee/Hip Arthroplasty
Lead Sponsor:
Shaare Zedek Medical Center
Conditions:
Total Knee and Total Hip Arthroplasty
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
We hypothesize that Traumeel S is more effective than placebo in reducing 48-hour mean cumulative morphine consumption following Total Knee or Hip Arthroplasty. 224 patients, meeting all inclusion an...
Eligibility Criteria
Inclusion
- Patients of either sex undergoing unilateral THAP or TKAP.
- Age over 18 years.
- Signature upon informed consent form
Exclusion
- Participation in another clinical trial within 4 weeks prior to enrollment.
- Refused to give verbal consent to the telephone interviews
- Impossibility to be reached during the 14-17 days post operative
- Inability to comply with the study protocol for any other reason
- Previous major surgical procedure on ipsilateral leg.
- Current use of analgesics for any other reason.
- A history of chronic pain syndrome.
- Abused legal or illicit drug use.
- Hypersensitivity to botanicals of the Compositae family
- Known sensitivity to paracetamol, codeine or tramadol.
Key Trial Info
Start Date :
August 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
224 Patients enrolled
Trial Details
Trial ID
NCT00307853
Start Date
August 1 2008
Last Update
October 20 2009
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Dept. of Orthopedic Surgery, Shaare Zedek Medical Center
Jerusalem, Israel, 91031
2
Department of Orthopedics, Meir Medical Center
Kfar Saba, Israel