A Two Centre Study to Assess the Stability and Long-term Performance of the C-Stem™ AMT in a Tota… (NCT00872573) | Clinical Trial Compass
TerminatedPhase 4
A Two Centre Study to Assess the Stability and Long-term Performance of the C-Stemâ„¢ AMT in a Total Primary Hip Replacement
Stopped: Technical issues with RSA at main site and departure of Principal Investigator
United Kingdom5 participantsStarted 2006-07-01
Plain-language summary
The purpose of this study is to monitor the stability of the C-Stemâ„¢ 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.
Who can participate
Age range60 Years – 80 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
What they're measuring
1
Distal migration of the femoral stem at the 5-year time point