A Multi-centre Study to Assess the Long-term Performance of the Summit™ Hip in Primary Total Hip Replacement
Status and phase
Conditions
Treatments
Details and patient eligibility
About
The purpose of this study is to monitor the performance of the Summit™ hip 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 and x-ray assessments.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
i) Male or female subjects, aged between 18 and 70 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 who require primary total hip replacement and are considered suitable for a cementless femoral stem.
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 who have previously undergone a hemi-arthroplasty or total hip arthroplasty.
iii) Women who are pregnant.
iv) Subjects who are known drug or alcohol abusers or with psychological disorders that could effect follow-up care or treatment outcomes.
v) Subjects who have participated in a clinical study with an investigational product in the last 12 months.
vi) Subjects who are currently involved in any injury litigation claims.
Trial design
Primary purpose
Allocation
Interventional model
Masking
275 participants in 1 patient group
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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