RECRUITING

MDR - PMCF Study for Taperloc Complete Stems

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Post Market Clinical Follow up Study to Provide Safety, Performance and Clinical Benefits Data of the Taperloc Complete Stems

Quick Facts

Study Start:2020-02-13
Study Completion:2032-02-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04028687

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Patient must be 18 years of age or older and skeletally mature
  2. * Patient must be willing and able to sign IRB approved informed consent
  3. * Patient must have undergone primary or revision hip arthroplasty with the -Taperloc Complete stem according to a cleared indication, which includes the following:
  4. * Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis
  5. * Rheumatoid arthritis
  6. * Correction of functional deformity
  7. * Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques
  1. * Off-label use
  2. * Infection
  3. * Sepsis
  4. * Osteomyelitis
  5. * Uncooperative patient or patient with neurologic disorders who are incapable of following directions
  6. * Osteoporosis
  7. * Metabolic disorders which may impair bone formation
  8. * Osteomalacia
  9. * Distant foci of infections which may spread to the implant site
  10. * Rapid joint destruction, marked bone loss or bone resorption apparent on roentgenogram
  11. * Vascular insufficiency, muscular atrophy, or neuromuscular disease
  12. * Patient is known to be pregnant or nursing
  13. * Patient is a prisoner
  14. * Patient is a known alcohol or drug abuser
  15. * Patient has a psychiatric illness or cognitive deficit that will not allow for proper informed consent

Contacts and Locations

Study Contact

Abigail Fishel
CONTACT
574-526-1765
Abigail.Fishel@zimmerbiomet.com
Lynsey Boyle
CONTACT
412-552-7111
Lynsey.Boyle@zimmerbiomet.com

Study Locations (Sites)

Orthopaedic Institute of Henderson
Henderson, Nevada, 89052
United States
Texas Health Physicians Group
Plano, Texas, 75243
United States
Proliance Orthopaedics and Sports Medicine
Bellevue, Washington, 98004
United States

Collaborators and Investigators

Sponsor: Zimmer Biomet

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-02-13
Study Completion Date2032-02-12

Study Record Updates

Study Start Date2020-02-13
Study Completion Date2032-02-12

Terms related to this study

Additional Relevant MeSH Terms

  • Hip Arthritis
  • Hip Disease
  • Hip Fractures
  • Hip Injuries
  • Hip Pain Chronic