MDR - PMCF Study for Taperloc Complete Stems
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorZimmer Biomet
About this trial
The objective of this consecutive series PMCF study is to collect data confirming safety, performance, and clinical benefits of the Taperloc Complete stems when used for primary or revision total hip arthroplasty (implants) at 1,3,5,7 and 10-year follow-up\*. Since Taperloc Complete was introduced to the EU in 2010, all available retrospective data will be collected from each patient and a prospective aspect to the study will be necessary to reach the 10-year time point.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patient must be 18 years of age or older and skeletally mature
Patient must be willing and able to sign IRB approved informed consent
Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis
Rheumatoid arthritis
Disqualifiers
Off-label use
Infection
Sepsis
Osteomyelitis
Trial population
A consecutive series of patients implanted with the Taperloc Complete Stems in primary or revision total hip arthroplasty according to the approved indications.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Taperloc Complete Stem
DevicePatients that have been implanted with a Taperloc Complete Stem to improve hip malfunction/disease.
Treatment groups
820 Participants
are divided into 1 treatment groupGroup A: Taperloc Complete Stems1 intervention
Trial outcomes
Primary outcomes
1
Device Safety assessed through the frequency and incidence of revisions, complications and Adverse Events.
The primary objective of this study is the assessment of safety by analyzing implant survivorship. This will be established by recording the incidence and frequency of revisions, complications and adverse events. Relation of the events to either implant or instrumentation should be specified.
Time frame
Out to 10 YearsSecondary outcomes
1
Device Performance and Benefits evaluated through the Harris Hip Score
The HHS is divided into 4 sub-categories; pain (44 points), function (47 points), range of motion (5 points), and absence of deformity (4 points). Patients select a discrete set of answers which correspond to predefined point allocations based on the category. To obtain a final score, these values are summed.
Time frame
Out to 10 Years2
Device Performance and Benefits evaluated through the Oxford Hip Score
The OHS is a patient-completed, 12-question evaluation. Each item is scored from 1 to 5, with 1 representing best outcome/least symptoms and 5 representing worst outcome/most symptoms.
Time frame
Out to 10 YearsSponsors and contacts
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Source ClinicalTrials.gov