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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:
ClinicalTrials.gov Identifier:
NCT00872066
First Posted: March 31, 2009
Last Update Posted: March 3, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
DePuy International
  Purpose
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

Condition Intervention Phase
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 Device: SmartSet® GHV bone cement Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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)

Resource links provided by NLM:


Further study details as provided by DePuy International:

Primary Outcome Measures:
  • Kaplan-Meier survivorship [ Time Frame: Annually ]

Secondary Outcome Measures:
  • Harris Hip Score [ Time Frame: Annually ]
  • Oxford Hip Score [ Time Frame: Annually ]
  • Radiological Analysis [ Time Frame: Annually ]

Enrollment: 243
Study Start Date: March 2006
Study Completion Date: July 2016
Primary Completion Date: July 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1) SmartSet® HV Bone Cement
A high viscosity bone cement for use in total hip replacement (without gentamicin)
Device: SmartSet® HV bone cement
A high viscosity bone cement for use in total hip replacement (without gentamicin)
Active Comparator: 2) SmartSet® GHV Bone Cement
A high viscosity bone cement for use in total hip replacement (with gentamicin)
Device: SmartSet® GHV bone cement
A high viscosity bone cement for use in total hip replacement (with gentamicin)

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00872066


Locations
Slovakia
Orthopaedic-traumatology Clinic University Hospital Martin
Martin, Slovakia
Sponsors and Collaborators
DePuy International
Investigators
Principal Investigator: Libor Nečas, M.D. Orthopaedic-truamatology Clinic, University Hospital Martin, Slovakia
  More Information

Responsible Party: DePuy International
ClinicalTrials.gov Identifier: NCT00872066     History of Changes
Other Study ID Numbers: CT02/11
First Submitted: March 19, 2009
First Posted: March 31, 2009
Last Update Posted: March 3, 2017
Last Verified: March 2017

Keywords provided by DePuy International:
Hip
Bone Cement

Additional relevant MeSH terms:
Arthritis
Osteoarthritis
Arthritis, Rheumatoid
Fractures, Bone
Necrosis
Femoral Fractures
Hip Dislocation
Hip Dislocation, Congenital
Slipped Capital Femoral Epiphyses
Collagen Diseases
Rheumatic Diseases
Joint Diseases
Musculoskeletal Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Wounds and Injuries
Pathologic Processes
Leg Injuries
Joint Dislocations
Bone Diseases
Hip Injuries
Musculoskeletal Abnormalities
Congenital Abnormalities
Osteochondrodysplasias
Bone Diseases, Developmental
Epiphyses, Slipped
Gentamicins
Anti-Bacterial Agents
Anti-Infective Agents