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

Sponsor

Hadassah Medical Organization (Other)

Overall Status

Completed

CT.gov ID

NCT00542139

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

4.5

Patients Per Site Per Month

Study Details

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).

Condition or Disease	Intervention/Treatment	Phase
Osteoarthritis	Drug: Betamethasone Drug: Bupivocaine	Phase 4

Study Design

Study Type:

Interventional

Anticipated Enrollment :

50 participants

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.

Study Start Date :

Dec 1, 2007

Actual Primary Completion Date :

Nov 1, 2008

Actual Study Completion Date :

Nov 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
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

Arm

Intervention/Treatment

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

Outcome Measures

Primary Outcome Measures

Visual analogue pain score [6 weeks]

Secondary Outcome Measures

Timed Up and Go Score [6 weeks]
Functional Ambulatory Category Scale [6 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	Hadassah Medical Organization	Jerusalem		Israel

Sponsors and Collaborators

Hadassah Medical Organization

Investigators

Principal Investigator: Leonid Kandel, MD, Hadassah Medical Organization

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

, ,

ClinicalTrials.gov Identifier:

NCT00542139

Other Study ID Numbers:

DIPROSPAN- HMO-CTIL

First Posted:

Oct 10, 2007

Last Update Posted:

Nov 11, 2008

Last Verified:

Oct 1, 2007

Keywords provided by , ,

Additional relevant MeSH terms:

Osteoarthritis

Betamethasone

Study Results

No Results Posted as of Nov 11, 2008