NCT00542139

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Dec 2007

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 7, 2007

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 10, 2007

Completed
2 months until next milestone

Study Start

First participant enrolled

December 1, 2007

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2008

Completed
Last Updated

November 11, 2008

Status Verified

October 1, 2007

Enrollment Period

11 months

First QC Date

October 7, 2007

Last Update Submit

November 9, 2008

Conditions

Osteoarthritis

Keywords

OsteoarthritisKnee arthroplastySteroid injectionRehabilitation

Outcome Measures

Primary Outcomes (1)

  • Visual analogue pain score

    6 weeks

Secondary Outcomes (2)

  • Timed Up and Go Score

    6 weeks

  • Functional Ambulatory Category Scale

    6 weeks

Study Arms (2)

1

EXPERIMENTAL
Drug: Betamethasone

2

ACTIVE COMPARATOR
Drug: Bupivocaine

Interventions

BetamethasoneDRUG

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

1
BupivocaineDRUG

Intraarticular injection of 10ml of Bupivocaine

2

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Active infection
  • Allergy to medication compounds
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hadassah Medical Organization

Jerusalem, Israel

Location

MeSH Terms

Conditions

Osteoarthritis

Interventions

Betamethasone

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

PregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, Fluorinated

Study Officials

  • Leonid Kandel, MD

    Hadassah Medical Organization

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 7, 2007

First Posted

October 10, 2007

Study Start

December 1, 2007

Primary Completion

November 1, 2008

Study Completion

November 1, 2008

Last Updated

November 11, 2008

Record last verified: 2007-10

Locations

IL(1)