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| Sponsored by: |
Hadassah Medical Organization |
|---|---|
| Information provided by: | Hadassah Medical Organization |
| ClinicalTrials.gov Identifier: | NCT00542139 |
Purpose
This study is performed to assess the influence of intraarticular injection of 2ml Diprospan (wich contains 4mg Betamethasone sodium phosphate and 10mg Betamethasone dipropionate) into osteoarthritic knee in patients who undergo a total knee replacement of their contralateral knee.
The study population will include 50 patients with bilateral knee osteoarthritis, admitted for their first knee replacement surgery. Only patients with older than 50 years with primary osteoarthritis will be included. The patients will be randomized into 2 groups. Intervention group will receive an injection of 2ml Diprospan diluted in 10 ml Bupivocaine. The control group will receive an injection of 10ml of Bupivocaine. All patients will be followed after 6 weeks and three functional rehabilitation and pain scores will be assessed (VAS pain score, Timed Up and Go Score and Functional Ambulatory Category Scale).
| Condition | Intervention | Phase |
|---|---|---|
|
Osteoarthritis |
Drug: Betamethasone Drug: Bupivocaine |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study |
| Official Title: | Evaluation of the Efficacy of Diprospan Injection to the Knee on Rehabilitation of Patients With Bilateral Knee Osteoarthritis After TKR of the Contralateral Knee. |
| Estimated Enrollment: | 50 |
| Study Start Date: | December 2007 |
| Study Completion Date: | November 2008 |
| Primary Completion Date: | November 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 1: Experimental |
Drug: Betamethasone
Intraarticular injection of 2ml Diprospan (wich contains 4mg Betamethasone sodium phosphate and 10mg Betamethasone dipropionate)
|
| 2: Active Comparator |
Drug: Bupivocaine
Intraarticular injection of 10ml of Bupivocaine
|
Eligibility| Ages Eligible for Study: | 50 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations More Information
| Responsible Party: | Hadassah Medical Organization ( Leonid Kandel ) |
| Study ID Numbers: | DIPROSPAN- HMO-CTIL |
| Study First Received: | October 7, 2007 |
| Last Updated: | November 9, 2008 |
| ClinicalTrials.gov Identifier: | NCT00542139 |
| Health Authority: | Israel: Israeli Health Ministry Pharmaceutical Administration |
|
Osteoarthritis Knee arthroplasty Steroid injection Rehabilitation |
|
Betamethasone-17,21-dipropionate Osteoarthritis, Knee Sodium phosphate Musculoskeletal Diseases Osteoarthritis |
Betamethasone sodium phosphate Joint Diseases Arthritis Rheumatic Diseases Betamethasone |
|
Anti-Inflammatory Agents Respiratory System Agents Therapeutic Uses Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists |
Anti-Asthmatic Agents Hormones Glucocorticoids Pharmacologic Actions |
