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

Part of paid clinical trials in Rancho Mirage, California.

Sponsor
Smith & Nephew, Inc.
Study ID
NCT03610789
Status
Enrolling By Invitation

Conditions

  • Hip Replacement

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • REDAPT — DEVICE
    REDAPT Monolithic Sleeveless Stems and Acetabular Cup Components

Study Details

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.

Key Dates

Start date
May 7, 2018
Status verified
Dec 2024
Primary completion
Jul 1, 2034
Completion
Jul 1, 2034

Study Design

Enrollment
220 participants (estimated)

Arms

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

Primary Outcome Measure

Revision rate [ Time Frame: 10 years post-op ]

Locations (4)

FacilityCityStateZIPSite coordinators
Eisenhower Medical Center-HospitalRancho MirageCalifornia92270-
Scripps MercySan DiegoCalifornia92103-
Hospital for Surgery- New YorkNew YorkNew York10021-
NYU Langone Health Orthopedic HospitalNew YorkNew York10003-

Find similar trials in Rancho Mirage, CA

By research site
Eisenhower Medical Center-Hospital· Rancho Mirage, CAScripps Mercy· San Diego, CAHospital for Surgery- New York· New York, NYNYU Langone Health Orthopedic Hospital· New York, NY

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