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Study of Taperloc Complete Stems for Hip Replacement

This study is looking at the Taperloc Complete Stem, a device used in hip replacement surgery for conditions like hip arthritis or fractures. The goal is to confirm how safe and effective these stems are over time. Researchers will collect information from patients who have already received a Taperloc Complete Stem as part of their hip replacement. They will track things like whether the stem needs to be replaced, any complications, or other issues for up to 10 years. To join, you must be at least 18 years old, have received a Taperloc Complete Stem for a hip replacement, and be willing to sign an informed consent form. The study is currently unclear on its recruitment status.

Study design
This is an observational study, meaning researchers will collect data from patients who have already received the Taperloc Complete Stem. It plans to include 820 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for up to 10 years to assess the safety and performance of the device.

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NCT04028687

MDR - PMCF Study for Taperloc Complete Stems

Recruiting
Not specifiedAges 18+Observational
Zimmer Biomet
~820 participants
Updated 2025-03-11 on ClinicalTrials.gov
What's tested:Taperloc Complete Stem

At a glance

Recruiting sites
1 of 3 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Device Safety assessed through the frequency and incidence of revisions, complications and Adverse Events.
Measured over Out to 10 Years

Conditions

Hip Arthritis
Hip Disease
Hip Fractures
Hip Injuries
Hip Pain Chronic

Explore related trials

Avascular NecrosisFunctional DeformityHip FractureNon-unionOsteoarthritisRheumatoid Arthritis

Where it's being run

3 sites across 3 states
Nevada1
Texas1
Washington1

Who to contact

Megan McKinnie
[email protected]
+1 (919) 381-7091
Email the study team

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Eligibility criteria

Inclusion

Patient must be 18 years of age or older and skeletally mature
Patient must be willing and able to sign IRB approved informed consent
Patient must have undergone primary or revision hip arthroplasty with the -Taperloc Complete stem according to a cleared indication, which includes the following:
Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis
Rheumatoid arthritis
Correction of functional deformity
Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques

Exclusion

Off-label use
Infection
Sepsis
Osteomyelitis
Uncooperative patient or patient with neurologic disorders who are incapable of following directions
Osteoporosis
Metabolic disorders which may impair bone formation
Osteomalacia
Distant foci of infections which may spread to the implant site
Rapid joint destruction, marked bone loss or bone resorption apparent on roentgenogram
Vascular insufficiency, muscular atrophy, or neuromuscular disease
Patient is known to be pregnant or nursing
Patient is a prisoner
Patient is a known alcohol or drug abuser
Patient has a psychiatric illness or cognitive deficit that will not allow for proper informed consent

What this trial measures

  • Device Safety assessed through the frequency and incidence of revisions, complications and Adverse Events.Out to 10 Years

    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.