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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT00208403
Other study ID # CT02/08
Secondary ID
Status Terminated
Phase Phase 4
First received September 13, 2005
Last updated March 27, 2017
Start date October 2002
Est. completion date October 2005

Study information

Verified date March 2017
Source DePuy International
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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, Acryloc™ 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 Acryloc™ 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


Recruitment information / eligibility

Status Terminated
Enrollment 36
Est. completion date October 2005
Est. primary completion date October 2005
Accepts healthy volunteers No
Gender All
Age group 60 Years to 75 Years
Eligibility 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.

Study Design


Intervention

Device:
Acryloc™ GHV
A high viscosity bone cement for use in total hip replacement
Palacos R
A high viscosity bone cement for use in total hip replacement

Locations

Country Name City State
Norway University Hospital of Trondheim Trondheim Sor-Trondelag

Sponsors (1)

Lead Sponsor Collaborator
DePuy International

Country where clinical trial is conducted

Norway, 

Outcome

Type Measure Description Time frame Safety issue
Primary Distal migration of the femoral prosthesis from the time of implantation to the 2 year follow-up assessment 2 Year
Secondary Annual posterior (AP) and medio-lateral (ML) RSA translations Annually
Secondary Merle D'Aubigne score Annually
Secondary Radiographic analysis Annually
Secondary Kaplan-Meier Survivorship - Revision of any component for any reason Throughout Study
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