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

Primary Purpose

Osteoarthritis

Status
Completed
Phase
Phase 4
Locations
Israel
Study Type
Interventional
Intervention
Betamethasone
Bupivocaine
Sponsored by
Hadassah Medical Organization
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis focused on measuring Osteoarthritis, Knee arthroplasty, Steroid injection, Rehabilitation

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • Active infection
  • Allergy to medication compounds
  • Pregnancy

Sites / Locations

  • Hadassah Medical Organization

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1

2

Arm Description

Outcomes

Primary Outcome Measures

Visual analogue pain score

Secondary Outcome Measures

Timed Up and Go Score
Functional Ambulatory Category Scale

Full Information

First Posted
October 7, 2007
Last Updated
November 9, 2008
Sponsor
Hadassah Medical Organization
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1. Study Identification

Unique Protocol Identification Number
NCT00542139
Brief Title
Evaluation of Diprospan Injection to the Knee on Rehabilitation of Patients After TKR of the Contralateral Knee
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.
Study Type
Interventional

2. Study Status

Record Verification Date
October 2007
Overall Recruitment Status
Completed
Study Start Date
December 2007 (undefined)
Primary Completion Date
November 2008 (Actual)
Study Completion Date
November 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Hadassah Medical Organization

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis
Keywords
Osteoarthritis, Knee arthroplasty, Steroid injection, Rehabilitation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Betamethasone
Intervention Description
Intraarticular injection of 2ml Diprospan (wich contains 4mg Betamethasone sodium phosphate and 10mg Betamethasone dipropionate)
Intervention Type
Drug
Intervention Name(s)
Bupivocaine
Intervention Description
Intraarticular injection of 10ml of Bupivocaine
Primary Outcome Measure Information:
Title
Visual analogue pain score
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Timed Up and Go Score
Time Frame
6 weeks
Title
Functional Ambulatory Category Scale
Time Frame
6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age older than 50 Bilateral primary knee osteoarthritis Undergoing knee arthroplasty Exclusion Criteria: Active infection Allergy to medication compounds Pregnancy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Leonid Kandel, MD
Organizational Affiliation
Hadassah Medical Organization
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hadassah Medical Organization
City
Jerusalem
Country
Israel

12. IPD Sharing Statement

Learn more about this trial

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

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