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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT00872573
Other study ID # CT03/14
Secondary ID
Status Terminated
Phase Phase 4
First received March 30, 2009
Last updated June 23, 2017
Start date July 1, 2006
Est. completion date October 1, 2007

Study information

Verified date June 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 the C-Stem™ AMT hip within the thigh bone when used in the treatment of patients with hip joint disease requiring a total hip replacement. Patients who enter the study will be evaluated at regular intervals following hip surgery using patient, clinical, standard x-ray assessments and special x-rays which allow the stability of the implant to be determined.


Recruitment information / eligibility

Status Terminated
Enrollment 5
Est. completion date October 1, 2007
Est. primary completion date October 1, 2007
Accepts healthy volunteers No
Gender All
Age group 60 Years to 80 Years
Eligibility Inclusion Criteria:

i) Male or female subjects, aged between 60 and 80 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 undergoing primary total hip replacement that are considered suitable for a cemented femoral stem and metal femoral head and an all polyethylene acetabular cup.

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) Subjects undergoing revision hip replacement

iii) Subjects undergoing simultaneous bilateral hip replacements.

iv) Subjects with a contralateral hip replacement, which was implanted less than six months previously or is not performing satisfactorily.

v) Women who are pregnant.

vi) Subjects who are known drug or alcohol abusers or with psychological disorders that could affect follow-up care or treatment outcomes.

vii) Subjects who have participated in a clinical study with an investigational product in the last 12 months.

viii) Subjects who are currently involved in any injury litigation claims.

Study Design


Intervention

Device:
C-Stem™ AMT Femoral Component (standard and high off-set variants)
A polished triple tapered cemented femoral component for use in total hip replacement

Locations

Country Name City State
United Kingdom North Bristol NHS Trust Bristol

Sponsors (1)

Lead Sponsor Collaborator
DePuy International

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Distal migration of the femoral stem at the 5-year time point 5 years
Secondary ML/AP translation and all rotations out to 5 years pre-discharge, 3mths, 6mths, 1yr, 18mths, 2yrs, 3yrs and 5yrs post-surgery
Secondary Harris Hip score 3mths, 1yr, 2yrs, 5yrs and 10yrs post-surgery
Secondary Oxford Hip score 3mths, 1yr, 2yrs, 5yrs and 10yrs post-surgery
Secondary Radiological analysis 3mths, 1yr, 2yrs, 5yrs and 10yrs post-surgery
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