Allofit® IT Ceramic Bearing System in Total Hip Arthroplasty (NCT03672916) | Clinical Trial Compass
CompletedNot Applicable
Allofit® IT Ceramic Bearing System in Total Hip Arthroplasty
Germany, Sweden185 participantsStarted 2011-05
Plain-language summary
This is a multi-center, prospective, non-controlled post market surveillance study. The objectives of this study are to obtain survival and outcome data on the Allofit IT Shell in combination with the BIOLOX® delta Taper Liner when used in primary total hip arthroplasty.
Who can participate
Age range18 Years – 75 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:
* Patient is 18 to 75 years of age, inclusive.
* Patient is skeletally mature.
* Patient qualifies for primary unilateral or bilateral total hip arthroplasty (THA) based on physical exam and medical history including the following:
* Avascular necrosis (AVN)
* Osteoarthritis (OA)
* Inflammatory arthritis (i.e. Rheumatoid arthritis)
* Post-traumatic arthritis
* Patient has no history of previous prosthetic replacement device (any type, including surface replacement arthroplasty, endoprosthesis, etc.) of the affected hip joint(s).
* Patient has a Harris Hip Score \<70 in the affected hip
* Patient is willing and able to provide written informed consent.
* Patient is willing and able to cooperate in the required post-operative therapy.
* Patient is willing and able to complete scheduled follow-up evaluations as described in the Informed Consent.
* Patient has participated in the Informed Consent process and has signed the Ethics Committee approved informed consent.
Exclusion Criteria:
* The patient is:
* A prisoner
* Mentally incompetent or unable to understand what participation in the study entails
* A known alcohol or drug abuser
* Anticipated to be non-compliant.
* The patient has a neuromuscular disorder, vascular disorder or other conditions that could contribute to prosthesis instability, prosthesis fixation failure, or complications in postoperative care.
* The patient has a vascular (large and small vessel disease) insufficiency.…