A Randomised Single Centre Study to Compare the Long-term Performance of SmartSet® HV and Palacos® R Bone Cements in Primary Total Hip Replacement

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2011 by DePuy International.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
DePuy International
ClinicalTrials.gov Identifier:
NCT00208403
First received: September 13, 2005
Last updated: September 1, 2011
Last verified: September 2011
  Purpose

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, SmartSet® HV 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 SmartSet® HV 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


Condition Intervention Phase
Osteoarthritis
Post-traumatic Arthritis
Avascular Necrosis
Device: Smartset HV Bone Cement
Device: Palacos R
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: Randomised, Prospective, RSA, PMS Study Comparing SmartSet HV & Palacos R in Primary Total Hip Arthroplasty

Resource links provided by NLM:


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 [ Time Frame: Annually ] [ Designated as safety issue: No ]
  • Merle D'Aubigne score [ Time Frame: Annually ] [ Designated as safety issue: No ]
  • Radiographic analysis [ Time Frame: Annually ] [ Designated as safety issue: No ]

Enrollment: 36
Study Start Date: October 2002
Primary Completion Date: January 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
SmartSet HV
Device: Smartset HV Bone Cement
A high viscosity bone cement for use in total hip replacement
Active Comparator: 2
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
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, see Learn About Clinical Studies.

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

Locations
Norway
University Hospital of Trondheim
Trondheim, Norway
Sponsors and Collaborators
DePuy International
  More Information

No publications provided

Responsible Party: Roy Harvey, Clinical Research Manager, DePuy International Ltd
ClinicalTrials.gov Identifier: NCT00208403     History of Changes
Other Study ID Numbers: CT02/08
Study First Received: September 13, 2005
Last Updated: September 1, 2011
Health Authority: Norway: Directorate of Health

Keywords provided by DePuy International:
Hip
Cement

Additional relevant MeSH terms:
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Polymethyl Methacrylate
Antimutagenic Agents
Cardiovascular Agents
Pharmacologic Actions
Physiological Effects of Drugs
Protective Agents
Therapeutic Uses
Vasodilator Agents

ClinicalTrials.gov processed this record on October 21, 2014