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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 is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
DePuy International
ClinicalTrials.gov Identifier:
NCT00872066
First received: March 19, 2009
Last updated: August 21, 2012
Last verified: August 2012
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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:

U.S. FDA Resources

Further study details as provided by DePuy International:

Primary Outcome Measures:
  • Kaplan-Meier survivorship [ Time Frame: Annually ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Harris Hip Score [ Time Frame: Annually ] [ Designated as safety issue: No ]
  • Oxford Hip Score [ Time Frame: Annually ] [ Designated as safety issue: No ]
  • Radiological Analysis [ Time Frame: Annually ] [ Designated as safety issue: No ]

Enrollment: 243
Study Start Date: March 2006
Estimated Study Completion Date: December 2020
Estimated Primary Completion Date: December 2020 (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

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00872066

Locations
Slovakia
Orthopaedic-traumatology Clinic University Hospital Martin
Martin, Slovakia
Sponsors and Collaborators
DePuy International
  More Information

No publications provided

Responsible Party: DePuy International
ClinicalTrials.gov Identifier: NCT00872066     History of Changes
Other Study ID Numbers: CT02/11
Study First Received: March 19, 2009
Last Updated: August 21, 2012
Health Authority: Slovakia: State Institute for Drug Control

Keywords provided by DePuy International:
Hip
Bone Cement

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Collagen Diseases
Femoral Fractures
Fractures, Bone
Hip Dislocation, Congenital
Necrosis
Osteonecrosis
Osteoarthritis
Joint Diseases
Musculoskeletal Diseases
 Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Wounds and Injuries
Leg Injuries
Musculoskeletal Abnormalities
Congenital Abnormalities
Pathologic Processes
Bone Diseases

ClinicalTrials.gov processed this record on May 23, 2013