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Current Clinical Trials

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
  1. Erik Schnaser, MD
    Erik Schnaser, MD
  2. for people 18 Years to ERR (full criteria)
  3. Rancho Mirage, CA
  4. study started May 2018
  5. Erik Schnaser, MD
  6. Currently not accepting new patients

Description

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.

Official Title

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

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).... more
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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).

Keywords

Hip Replacement

Eligibility

for people 18 Years to ERR
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.... more
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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.

Lead Scientist at Eisenhower Health

Erik Schnaser, MD
Erik Schnaser, MD. is a fellowship-trained hip and knee replacement surgeon. He specializes in adult hip and knee disorders including pre-arthritic and arthritic conditions. He has a special interest in patient-specific instrumentation, surgical navigation, robotic surgery, as well as taking care of and revising patients with failing or failed total joint replacements. His surgical skill set includes, but is not limited to total hip replacements, total knee replacements, partial knee replacement... more
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Erik Schnaser, MD. is a fellowship-trained hip and knee replacement surgeon. He specializes in adult hip and knee disorders including pre-arthritic and arthritic conditions. He has a special interest in patient-specific instrumentation, surgical navigation, robotic surgery, as well as taking care of and revising patients with failing or failed total joint replacements. His surgical skill set includes, but is not limited to total hip replacements, total knee replacements, partial knee replacements, knee arthroscopies, total hip revisions, total knee revisions, and lower extremity traumatic injuries.

“The great thing about specializing in hip and knee replacements is that these procedures truly have the ability to give patients their lives back. Few careers are this rewarding.”

Dr. Schnaser is originally from Carson City, Nevada and is the son of an orthopedic surgeon. He received his Bachelors of Science in Biochemistry at the University of Southern California and then attended medical school at the University of Nevada School of Medicine. He then completed a surgical internship and an orthopedic surgical residency at Case Western Reserve School of Medicine. Following his residency, Dr. Schnaser completed a fellowship in adult hip and knee reconstruction at the Hospital for Special Surgery in New York City.

Dr. Schnaser is particularly interested in researching clinical outcomes after hip and knee replacements. He believes that patient-specific instrumentation, navigation, and robotics have the potential to increase patient satisfaction and clinical outcomes following joint replacement surgery. He has given over 20 national and international presentations stemming from his research, has authored several peer-reviewed publications, and has written book chapters on the subject of joint replacement surgery. He was a member of the America Academy of Orthopedic Surgeon’s Research Development Committee and has spent time on Capitol Hill in order to ensure that the National Institutes of Health continues to receive research support for musculoskeletal conditions.

Publications:

To view a listing of Dr. Schnaser's publications, click here.

Clinical Study Details

  1. Currently not accepting new patients
  2. study started May 2018
  4. NCT03610789
  5. Observational
  6. December 23, 2024