Zimmer Continuum Metal on Polyethylene (MoP) PostMarket Clinical Followup (PMCF) Study (NCT01307384) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Zimmer Continuum Metal on Polyethylene (MoP) PostMarket Clinical Followup (PMCF) Study
United States165 participantsStarted 2011-03-29
Plain-language summary
This is a prospective, multi-center, non-randomized, non-controlled study designed to obtain survival and outcome data on the Continuum Metal on Polyethylene Acetabular System when used in primary total hip arthroplasty.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion Criteria
* Patient is 18 to 75 years of age, inclusive.
* Patient is skeletally mature.
* Patient qualifies for primary unilateral or bilateral (simultaneous or staged) total hip arthroplasty (THA) based on physical exam and medical history including the following:
* Avascular necrosis (AVN)
* Osteoarthritis
* Inflammatory arthritis (i.e., Rheumatoid arthritis)
* Post-traumatic arthritis
* Patient has no history of previous prosthetic replacement device of any type, including surface replacement arthroplasty, endoprosthesis, etc. of the affected hip joint(s).
* Patient has moderate, marked or disabling pain.
* 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 IRB 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 neurologic condition in the ipsilateral or contralateral l…
What they're measuring
1
Survivorship
Timeframe: 6 weeks, 6 months, 1 year, 2 year, 3 year, 5 year, 7 year, and 10 year
2
Safety / Adverse Events
Timeframe: Surgery, 6 weeks, 6 months, 1 year, 2 year, 3 year, 5 year, 7 year, and 10 year