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

Hadassah Medical Center

Status and phase: Completed; Phase 4

Conditions: Osteoarthritis

Treatments: Drug: Betamethasone; Drug: Bupivocaine

Study type: Interventional

Funder types: Other

Identifiers

NCT00542139

DIPROSPAN- HMO-CTIL

Details and patient eligibility

About

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).

Enrollment: 50 estimated patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• Active infection
• Allergy to medication compounds
• Pregnancy

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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50 participants in 2 patient groups

1

Experimental group

Treatment:

Drug: Betamethasone

2

Active Comparator group

Treatment:

Drug: Bupivocaine