Status:
COMPLETED
Intra-articular Hyaluronan Substitution in Arthroscopy of the Wrist
Lead Sponsor:
TRB Chemedica AG
Conditions:
Arthroscopic Surgery
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
The primary objective of this study is to evaluate the efficacy and safety of Ostenil application (1% hyaluronan) after arthroscopy of the wrist.
Eligibility Criteria
Inclusion
- Male and female patients between 18 and 80 years of age
- Minimum pain score of 2 according to modified Mayo Wrist Score
- Patients in good general health/nutritional condition
- Signed written informed consent
Exclusion
- Alcohol / drug abuse, drug addiction or neurotic personality disorder; patients with mental illness or suicidal tendency
- Severe intercurrent illness (like uncontrolled diabetes mellitus or thyroid disease, carcinoma,...)
- Fertile women without medically secured contraception(hysterectomy, sterilization, contraceptives,...)
- Subjects having a high probability of non compliance to the study procedures according to investigator's judgement (like illiteracy, insufficient German linguistic knowledge)
- Contraindication for the use of one of the investigational products or for the scheduled anesthesia
- Concomitant or previous participation in a clinical trial within the last 3 months
- Intraarticular treatment with a sodium hyaluronate-based product within the last 6 months
- Intraarticular treatment by the use of corticoid containing substance within the last 3 months
- Concomitant illness or injury influencing study evaluation
Key Trial Info
Start Date :
January 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2009
Estimated Enrollment :
140 Patients enrolled
Trial Details
Trial ID
NCT01254682
Start Date
January 1 2007
End Date
August 1 2009
Last Update
September 28 2011
Active Locations (1)
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1
Orthopädische Gemeinschaftspraxis
Straubing, Bavaria, Germany, 94315