A Randomised Single Centre Study to Compare the Long-term Performance of Acryloc™ and Palacos® R Bone Cements in Primary Total Hip Replacement
NCT00208403 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 36
Last updated 2017-03-28
Summary
The purpose of this study is to monitor the stability of a total hip replacement within the thigh bone when used in artificial hip joints implanted with two different bone cements, Acryloc™ and Palacos® R, in the treatment of patients with hip joint disease requiring a total hip replacement. Patients who enter the study will be randomly allocated to Acryloc™ or Palacos® R and will be evaluated at regular intervals following hip surgery using patient, clinical, x-ray assessments and special x-rays which allow the stability of the hip implant to be determined
Conditions
- Osteoarthritis
- Post-traumatic Arthritis
- Avascular Necrosis
Interventions
- DEVICE
-
Acryloc™ GHV
A high viscosity bone cement for use in total hip replacement
- DEVICE
-
Palacos R
A high viscosity bone cement for use in total hip replacement
Sponsors & Collaborators
-
DePuy International
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 60 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2002-10-31
- Primary Completion
- 2005-10-31
- Completion
- 2005-10-31
Countries
- Norway
Study Locations
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