Clinical trial 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
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
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Hip Replacement
Lead sponsor: Smith & Nephew, Inc.
Sponsor class: INDUSTRY
First posted: 2018-08-01
Enrollment: 220
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
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.

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.

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).

Eligibility criteria: Inclusion Criteria:

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

1. Subject was considered skeletally mature at the time of surgery and was at least 18 years of age.
2. 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.
3. Subject required surgery with REDAPT device chosen for one of the following indications:

   1. 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).
   2. Fracture-dislocation of the hip, femoral neck fracture or trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.
   3. Revision THA
4. 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.
5. 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:

1. Subject had an active infection - systemic or at the site of surgery.
2. 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.
3. Subject is known to be at risk for loss to follow-up or failure to return for scheduled visits.
4. Subject is incarcerated or is pending incarceration.
5. Subject is enrolled in another clinical study that would affect the endpoints of the study.

Primary outcomes:
measure: Revision rate
timeFrame: 10 years post-op
Secondary outcomes:
measure: EuroQul Five Dimensions Questionnaire EQ-5D-5L
timeFrame: Collect retrospectively from medical records preoperatively and at 1 year, and prospectively at 2, 5, and 10 years post-operatively
measure: Functional outcomes as determined by the Hip Disability Osteoarthritis Outcome (HOOS) score
timeFrame: Collect retrospectively from medical records preoperatively and at 1 year, and prospectively at 2, 5, and 10 years post-operatively
measure: Radiographic assessments
timeFrame: Collect retrospectively from medical records preoperatively and at 1 year, and prospectively at 2, 5, and 10 years post-operatively
Other outcomes:
Locations:
city: Rancho Mirage
country: United States
facility: Eisenhower Medical Center-Hospital
state: California
city: San Diego
country: United States
facility: Scripps Mercy
state: California
city: New York
country: United States
facility: NYU Langone Health Orthopedic Hospital
state: New York
city: New York
country: United States
facility: Hospital for Surgery- New York
state: New York
Study officials:
affiliation: Smith & Nephew, Inc.
name: Nahomie Prophete
role: STUDY_CHAIR
References: