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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:
Information provided by:
Hadassah Medical Organization
ClinicalTrials.gov Identifier:
NCT00542139
First received: October 7, 2007
Last updated: November 9, 2008
Last verified: October 2007
History of Changes
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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:

U.S. FDA Resources

Further study details as provided by Hadassah Medical Organization:

Primary Outcome Measures:
  • Visual analogue pain score [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Timed Up and Go Score [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  • Functional Ambulatory Category Scale [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Leonid Kandel, Hadassah Medical Organization
ClinicalTrials.gov Identifier: NCT00542139     History of Changes
Other Study ID Numbers: DIPROSPAN- HMO-CTIL
Study First Received: October 7, 2007
Last Updated: November 9, 2008
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

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-17,21-dipropionate
Betamethasone dipropionate, betamethasone sodium phosphate drug combination
Betamethasone
Betamethasone sodium phosphate
 Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 19, 2013