PMCF Study on the Safety and Performance of the Alloclassic Variall Cup Ceramic Bearing System in… (NCT03672370) | Clinical Trial Compass
TerminatedNot Applicable
PMCF Study on the Safety and Performance of the Alloclassic Variall Cup Ceramic Bearing System in Total Hip Arthroplasty
Stopped: Study terminated as CE marks of the devices used have not been renewed.
Austria100 participantsStarted 2015-03-24
Plain-language summary
The study is a multicenter, prospective, non-randomized, non-controlled consecutive cohort post-market clinical follow-up study.
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 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
* 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 neurologic condition in the ipsilateral or contralateral limb which affects lower limb function.
* The patient has a known history …
What they're measuring
1
Clinical Success Will be Based on the Harris Hip Scoring System
Timeframe: 3 years
2
Percentage of Participants Who Survived According to the Survival Analysis With the Kaplan Meier (K-M) Estimate