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A Study to Assess the Long-term Performance of SmartSet® HV and SmartSet® GHV Bone Cements in Primary Total Hip Replacement

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
DePuy International
ClinicalTrials.gov Identifier:
NCT00872066
First received: March 19, 2009
Last updated: March 2, 2017
Last verified: March 2017
March 19, 2009
March 2, 2017
March 2006
July 2016   (Final data collection date for primary outcome measure)
Kaplan-Meier survivorship [ Time Frame: Annually ]
Same as current
Complete list of historical versions of study NCT00872066 on ClinicalTrials.gov Archive Site
  • Harris Hip Score [ Time Frame: Annually ]
  • Oxford Hip Score [ Time Frame: Annually ]
  • Radiological Analysis [ Time Frame: Annually ]
Same as current
Not Provided
Not Provided
 
A Study to Assess the Long-term Performance of SmartSet® HV and SmartSet® GHV Bone Cements in Primary Total Hip Replacement
A Prospective, Randomised, Uncontrolled, Single-Centre, Post-Market Surveillance Study To Evaluate The Performance Of SmartSet® HV and SmartSet® GHV Bone Cements In Primary Cemented Total Hip Arthroplasty(THA)
The purpose of this study is to monitor the performance of artificial hip joints implanted with two different bone cements, SmartSet® HV and SmartSet® GHV, in the treatment of patients with hip joint disease requiring a total hip replacement. Patients who enter the study will be randomly allocated to SmartSet® HV or SmartSet® GHV and will be evaluated at regular intervals following hip surgery using patient, clinical and x-ray assessments
Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: No masking
Primary Purpose: Treatment
  • Rheumatoid Arthritis
  • Osteoarthritis
  • Post-traumatic Arthritis
  • Collagen Disorders
  • Avascular Necrosis
  • Traumatic Femoral Fractures
  • Nonunion of Femoral Fractures
  • Congenital Hip Dysplasia
  • Slipped Capital Femoral Epiphysis
  • Device: SmartSet® HV bone cement
    A high viscosity bone cement for use in total hip replacement (without gentamicin)
  • Device: SmartSet® GHV bone cement
    A high viscosity bone cement for use in total hip replacement (with gentamicin)
  • Active Comparator: 1) SmartSet® HV Bone Cement
    A high viscosity bone cement for use in total hip replacement (without gentamicin)
    Intervention: Device: SmartSet® HV bone cement
  • Active Comparator: 2) SmartSet® GHV Bone Cement
    A high viscosity bone cement for use in total hip replacement (with gentamicin)
    Intervention: Device: SmartSet® GHV bone cement
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
243
July 2016
July 2016   (Final data collection date for primary outcome measure)

Inclusion Criteria:

i) Male or female subjects, aged between 18 and 75 years (inclusive).

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 requiring primary total hip arthroplasty and are considered suitable for a cemented femoral component.

Exclusion Criteria:

i) Subjects who, in the opinion of the Investigator, have an existing 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 with contraindications normally applicable to the use of conventional bone cement, in accordance with the manufacturer's Instructions For Use.

Sexes Eligible for Study: All
18 Years to 75 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Slovakia
 
 
NCT00872066
CT02/11
No
Not Provided
Not Provided
DePuy International
DePuy International
Not Provided
Principal Investigator: Libor Nečas, M.D. Orthopaedic-truamatology Clinic, University Hospital Martin, Slovakia
DePuy International
March 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP