MDR - PMCF Study for Taperloc Complete Stems

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.

Conditions

Hip Arthritis, Hip Disease, Hip Fractures, Hip Injuries, Hip Pain Chronic

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Study Overview

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Study Details

Study overview

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.

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

MDR - PMCF Study for Taperloc Complete Stems

Condition
Hip Arthritis
Intervention / Treatment

-

Contacts and Locations

Henderson

Orthopaedic Institute of Henderson, Henderson, Nevada, United States, 89052

Plano

Texas Health Physicians Group, Plano, Texas, United States, 75243

Bellevue

Proliance Orthopaedics and Sports Medicine, Bellevue, Washington, United States, 98004

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.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Zimmer Biomet,

Study Record Dates

2032-02-12