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NCT04028687 | RECRUITING | Hip Arthritis

MDR - PMCF Study for Taperloc Complete Stems
Sponsor:

Zimmer Biomet

Brief Summary:

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.

Condition or disease

Hip Arthritis

Hip Disease

Hip Fractures

Hip Injuries

Hip Pain Chronic

Intervention/treatment

Taperloc Complete Stem

Detailed 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. The primary objective is to confirm safety of the study products. This will be assessed by recording the incidence and frequency of revisions, complications, and adverse events. Relationship of the events to either implant or instrumentation should be specified. The secondary objective is the assessment of performance and clinical benefits by analyzing recorded patient-reported clinical outcomes measures (PROMs). \*The most recent available data will be used. If any of the listed time points are not available, data will be used from last available time point and follow-up will move forward at the closest available time point

Study Type : OBSERVATIONAL
Estimated Enrollment : 820 participants
Official Title : Post Market Clinical Follow up Study to Provide Safety, Performance and Clinical Benefits Data of the Taperloc Complete Stems
Actual Study Start Date : 2020-02-13
Estimated Primary Completion Date : 2032-02-12
Estimated Study Completion Date : 2032-02-12

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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
MDR - PMCF Study for Taperloc Complete Stems

Location Details

NCT04028687

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

WITHDRAWN

United States, Nevada

Orthopaedic Institute of Henderson

Henderson, Nevada, United States, 89052

RECRUITING

United States, Texas

Texas Health Physicians Group

Plano, Texas, United States, 75243

WITHDRAWN

United States, Washington

Proliance Orthopaedics and Sports Medicine

Bellevue, Washington, United States, 98004