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Evaluation of Diprospan Injection to the Knee on Rehabilitation of Patients After TKR of the Contralateral Knee

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00542139
First Posted: October 10, 2007
Last Update Posted: November 11, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Hadassah Medical Organization
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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.

Resource links provided by NLM:


Further study details as provided by Hadassah Medical Organization:

Primary Outcome Measures:
  • Visual analogue pain score [ Time Frame: 6 weeks ]

Secondary Outcome Measures:
  • Timed Up and Go Score [ Time Frame: 6 weeks ]
  • Functional Ambulatory Category Scale [ Time Frame: 6 weeks ]

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
Experimental: 1 Drug: Betamethasone
Intraarticular injection of 2ml Diprospan (wich contains 4mg Betamethasone sodium phosphate and 10mg Betamethasone dipropionate)
Active Comparator: 2 Drug: Bupivocaine
Intraarticular injection of 10ml of Bupivocaine

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age older than 50
  • Bilateral primary knee osteoarthritis
  • Undergoing knee arthroplasty

Exclusion Criteria:

  • Active infection
  • Allergy to medication compounds
  • Pregnancy
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00542139


Locations
Israel
Hadassah Medical Organization
Jerusalem, Israel
Sponsors and Collaborators
Hadassah Medical Organization
Investigators
Principal Investigator: Leonid Kandel, MD Hadassah Medical Organization
  More Information

Responsible Party: Leonid Kandel, Hadassah Medical Organization
ClinicalTrials.gov Identifier: NCT00542139     History of Changes
Other Study ID Numbers: DIPROSPAN- HMO-CTIL
First Submitted: October 7, 2007
First Posted: October 10, 2007
Last Update Posted: November 11, 2008
Last Verified: October 2007

Keywords provided by Hadassah Medical Organization:
Osteoarthritis
Knee arthroplasty
Steroid injection
Rehabilitation

Additional relevant MeSH terms:
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Betamethasone benzoate
Betamethasone-17,21-dipropionate
Betamethasone dipropionate, betamethasone sodium phosphate drug combination
Betamethasone
Betamethasone Valerate
Betamethasone sodium phosphate
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents