Collecting data on Taperloc Complete stems for hip surgeries
Post Market Clinical Follow up Study to Provide Safety, Performance and Clinical Benefits Data of the Taperloc Complete Stems
This study is trying to see how safe and effective the Taperloc Complete hip implants are for people who have had hip surgery, by looking at both past patients and following new ones over the years.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 820 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Zimmer Biomet Industry-sponsored |
| Locations | 3 sites (Henderson, Nevada and 2 other locations) |
| Trial ID | NCT04028687 on ClinicalTrials.gov |
What this trial studies
This observational study aims to gather data on the safety, performance, and clinical benefits of Taperloc Complete stems used in primary or revision total hip arthroplasty. It will involve both retrospective data collection from patients who have already undergone the procedure and prospective follow-up at 1, 3, 5, 7, and 10 years post-surgery. The study will assess the incidence of complications and revisions while also evaluating patient-reported outcomes to determine the clinical benefits of the implants.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older who have undergone primary or revision hip arthroplasty with Taperloc Complete stems for various hip conditions.
Not a fit: Patients with infections, sepsis, or other significant medical conditions that could impair healing or complicate the surgery may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the long-term safety and effectiveness of Taperloc Complete stems, potentially improving patient outcomes in hip surgeries.
How similar studies have performed: Other studies on hip arthroplasty implants have shown success in confirming safety and performance, making this approach well-supported by existing literature.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * 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
Where this trial is running
Henderson, Nevada and 2 other locations
- Orthopaedic Institute of Henderson — Henderson, Nevada, United States (Withdrawn)
- Texas Health Physicians Group — Plano, Texas, United States (Recruiting)
- Proliance Orthopaedics and Sports Medicine — Bellevue, Washington, United States (Withdrawn)
Study contacts
- Study coordinator: Megan McKinnie
- Email: megan.mckinnie@zimmerbiomet.com
- Phone: +1 (919) 381-7091
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.