Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
A Randomised Study to Compare the Long-Term Survivorship and Performance of Two Bone Cements Used in Primary Total Hip Arthroplasty
This study is ongoing, but not recruiting participants.
Sponsored by: DePuy International
Information provided by: DePuy International
ClinicalTrials.gov Identifier: NCT00208403
  Purpose

A randomised controlled trial to compare the performance of SmartSet HV & Palacos R bone cement by assessing the clinical and radiographic performance (including RSA stability data) of Charnley total hip replacements


Condition Intervention Phase
Primary Osteoarthritis
Device: Smartset HV Bone Cement
Device: Palacos R
Phase IV

MedlinePlus related topics: Osteoarthritis
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title: Randomised, Prospective, RSA, PMS Study Comparing SmartSet HV & Palacos R in Primary Total Hip Arthroplasty

Further study details as provided by DePuy International:

Primary Outcome Measures:
  • Distal migration of the femoral prosthesis from the time of implantation to the 2 year follow-up assessment [ Time Frame: 2 Year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Annual posterior (AP) and medio-lateral (ML) RSA translations, Merle D'Aubigne score, radiographic analysis [ Time Frame: Annual ] [ Designated as safety issue: No ]

Estimated Enrollment: 36
Study Start Date: October 2002
Estimated Study Completion Date: December 2009
Primary Completion Date: December 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Active Comparator
SmartSet HV
Device: Smartset HV Bone Cement
A high viscosity bone cement for use in total hip replacement
2: Active Comparator
Palacos R
Device: Palacos R
A high viscosity bone cement for use in total hip replacement

  Eligibility

Ages Eligible for Study:   60 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

i) Male or female subjects, aged 60 to 75 years (inclusive), and with a weight of less than 100kg.

ii) Subjects who are able to give voluntary, written informed consent to participate in this investigation and from whom consent has been obtained.

iii) Subjects who, in the opinion of the Investigator, are able to understand this investigation, co-operate with the investigational procedures and are willing to return to the hospital for all the required post-operative follow-ups.

iv) Subjects with non-inflammatory arthritis of the hip.

v) Subjects who require a primary total hip arthroplasty and are treated at the arthroplasty section of the orthopaedics department at the Investigational Centre.

vi) Subjects who are considered suitable for a cemented femoral stem and cemented acetabular component.

Exclusion Criteria:

i) Subjects who, in the opinion of the Investigator, have an existing condition such as malignancy, severe osteoporosis, disabling musculo-skeletal problems (other than in the hips) or any other condition that would compromise their participation and follow-up in this study.

ii) Women who are pregnant.

iii) Subjects who are known drug or alcohol abusers or with psychological disorders that could effect follow-up care or treatment outcomes.

iv) Subjects who have participated in a clinical study with an investigational product in the last 6 month(s).

v) Subjects who are currently involved in any injury litigation claims.

vi) Subjects undergoing corticosteroid treatment.

vii) Subjects with any condition for whom the use of conventional bone cement is contra-indicated.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00208403

Locations
Norway
University Hospital of Trondheim
Trondheim, Norway
Sponsors and Collaborators
DePuy International
Investigators
Study Director: Michael J Borroff, BSc, MSc DePuy International Ltd
  More Information

Responsible Party: DePuy International Ltd ( Michael Borroff )
Study ID Numbers: CT02/08
Study First Received: September 13, 2005
Last Updated: June 20, 2008
ClinicalTrials.gov Identifier: NCT00208403  
Health Authority: Norway: Directorate for Health and Social Affairs

Keywords provided by DePuy International:
Hip
Cement

Study placed in the following topic categories:
Polymethyl Methacrylate
Musculoskeletal Diseases
Osteoarthritis
Joint Diseases
Arthritis
Rheumatic Diseases

ClinicalTrials.gov processed this record on January 16, 2009