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

NCT ID: NCT00542139

Last Updated: 2008-11-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-12-31

Study Completion Date

2008-11-30

Brief Summary

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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).

Detailed Description

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Conditions

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Osteoarthritis

Keywords

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Osteoarthritis Knee arthroplasty Steroid injection Rehabilitation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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1

Group Type EXPERIMENTAL

Betamethasone

Intervention Type DRUG

Intraarticular injection of 2ml Diprospan (wich contains 4mg Betamethasone sodium phosphate and 10mg Betamethasone dipropionate)

2

Group Type ACTIVE_COMPARATOR

Bupivocaine

Intervention Type DRUG

Intraarticular injection of 10ml of Bupivocaine

Interventions

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Betamethasone

Intraarticular injection of 2ml Diprospan (wich contains 4mg Betamethasone sodium phosphate and 10mg Betamethasone dipropionate)

Intervention Type DRUG

Bupivocaine

Intraarticular injection of 10ml of Bupivocaine

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Active infection
* Allergy to medication compounds
* Pregnancy
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hadassah Medical Organization

OTHER

Sponsor Role lead

Responsible Party

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Hadassah Medical Organization

Principal Investigators

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Leonid Kandel, MD

Role: PRINCIPAL_INVESTIGATOR

Hadassah Medical Organization

Locations

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Hadassah Medical Organization

Jerusalem, , Israel

Site Status

Countries

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Israel

Other Identifiers

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DIPROSPAN- HMO-CTIL

Identifier Type: -

Identifier Source: org_study_id