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Enrolling by invitation NCT03610789

A Multicenter, Post-Market Clinical Follow-up Study of Subjects With the REDAPT™ System Monolithic Sleeveless/Sleeved Stem and/or Fully Porous Acetabular Shell With XLPE Liner and/or Modular Shell Components Previously Implanted

— Observational Hip Replacement

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: REDAPT.
Who it may be relevant to
Registry conditions: Hip Replacement. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

The primary purpose of this study is to demonstrate cumulative revision rate of the REDAPT System Monolithic Sleeveless/Sleeved Stem, Fully Porous Acetabular Shell with XLPE liner, and Modular Shell Components (with or without Staple, Slice and Blade Augments) at 10 years.

Detailed description

Retrospective-prospective, single arm, multicenter study of subjects previously implanted with the REDAPT System Monolithic Sleeveless/Sleeved Stem and/or Fully Porous Acetabular Shell with XLPE liner and/or Modular Shell Components (with or without Staple, Slice and Blade Augments).

Interventions

  • Device REDAPT
    REDAPT Monolithic Sleeveless Stems and Acetabular Cup Components

Primary outcome measures

  • Revision rate [Time frame: 10 years post-op]
Secondary outcome measures (3)
  • EuroQul Five Dimensions Questionnaire EQ-5D-5L [Time frame: Collect retrospectively from medical records preoperatively and at 1 year, and prospectively at 2, 5, and 10 years post-operatively]
  • Functional outcomes as determined by the Hip Disability Osteoarthritis Outcome (HOOS) score [Time frame: Collect retrospectively from medical records preoperatively and at 1 year, and prospectively at 2, 5, and 10 years post-operatively]
  • Radiographic assessments [Time frame: Collect retrospectively from medical records preoperatively and at 1 year, and prospectively at 2, 5, and 10 years post-operatively]

Eligibility criteria

Inclusion criteria

Subjects must meet all of the inclusion criteria to enroll in the study:

  • Subject was considered skeletally mature at the time of surgery and was at least 18 years of age.
  • Subject has undergone hip arthroplasty with the REDAPT Fully Porous Acetabular Shell with XLPE liner or REDAPT Modular Cup Components (with or without Staple, Slice and Blade Augments), and/or Monolithic Sleeveless Stem, and/or Monolithic Sleeved Stem and are at least 3 months post-implantation at this site.
  • Subject required surgery with REDAPT device chosen for one of the following indications:
  • Advanced degeneration of the hip joint as result of osteoarthritis, avascular necrosis, posttraumatic arthritis, rheumatoid arthritis, or dysplasia (or any of the composites of these conditions).
  • Fracture-dislocation of the hip, femoral neck fracture or trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.
  • Revision THA
  • Subject is willing to consent to and to follow the study visit schedule (as defined in the study protocol and ICF), by signing the IRB/IEC approved ICF.
  • Subject is willing and able to participate in required follow-up visits at the investigational site and to complete study procedures.

Exclusion criteria

Subjects meeting any of the following exclusion criteria will be excluded from study participation:

  • Subject had an active infection - systemic or at the site of surgery.
  • Subject, in the opinion of the PI, has an emotional or neurological condition that would pre-empt their ability or willingness to participate in the study including mental illness, mental retardation, drug or alcohol abuse.
  • Subject is known to be at risk for loss to follow-up or failure to return for scheduled visits.
  • Subject is incarcerated or is pending incarceration.
  • Subject is enrolled in another clinical study that would affect the endpoints of the study.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

United States · 4 centers
  • Eisenhower Medical Center-Hospital — Rancho Mirage
  • Scripps Mercy — San Diego
  • NYU Langone Health Orthopedic Hospital — New York
  • Hospital for Surgery- New York — New York

Identifiers

NCT: NCT03610789 · REDAPT 17-4538-02

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗