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

NCT03610789 | Enrolling By Invitation FDA Device

• 1 other identifier: REDAPT 17-4538-02
• Study Type: observational
• Target: 220
• Locations: 1 country
• Sites: 4

Brief Summary

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.

Conditions

Hip Replacement

Outcome Measures

Primary Outcomes (1)

• Revision rate

  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) cumulative revision rate for any reason 10 years postoperatively.

  10 years post-op

Secondary Outcomes (3)

• EuroQul Five Dimensions Questionnaire EQ-5D-5L

  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

  Collect retrospectively from medical records preoperatively and at 1 year, and prospectively at 2, 5, and 10 years post-operatively

• Radiographic assessments

  Collect retrospectively from medical records preoperatively and at 1 year, and prospectively at 2, 5, and 10 years post-operatively

Study Arms (1)

REDAPT Revision Femoral System

REDAPT Revision Femoral System Monolithic Sleeveless Stems, monolithic sleeved stems and/or Acetabular Components or modular shells and/or augments

Device: REDAPT

Interventions

REDAPT DEVICE

REDAPT Monolithic Sleeveless Stems and Acetabular Cup Components

REDAPT Revision Femoral System

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Smith & Nephew, Inc.: lead

Study Sites (4)

Eisenhower Medical Center-Hospital

Rancho Mirage, California, 92270, United States

Location

Scripps Mercy

San Diego, California, 92103, United States

Location

NYU Langone Health Orthopedic Hospital

New York, New York, 10003, United States

Location

Hospital for Surgery- New York

New York, New York, 10021, United States

Location

Study Officials

• Nahomie Prophete

  Smith & Nephew, Inc.

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 26, 2018
• First Posted: August 1, 2018
• Study Start: May 7, 2018
• Primary Completion (Estimated): July 1, 2034
• Study Completion (Estimated): July 1, 2034
• Last Updated: January 6, 2025

Record last verified: 2024-12

Locations

US (4)