Trial record 15 of 51 for:    Sapphire

ABC/Trident® Ceramic Post Approval Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Stryker Orthopaedics
ClinicalTrials.gov Identifier:
NCT00960206
First received: August 5, 2009
Last updated: July 24, 2014
Last verified: July 2014
  Purpose
The purpose of the Post Approval Study of the ABC and Trident® systems is to continue to demonstrate the safety and efficacy of the alumina-on-alumina bearing surfaces combined with the appropriate shell in a cementless application.

Condition Intervention
Arthroplasty, Replacement, Hip
Device: Trident® Ceramic Insert/Trident® AD HA Acetabular Shell
Device: Alumina Insert/PSL® Microstructured Acetabular Shell or Secur-Fit® HA PSL® Acetabular Shell
Device: OmniFit® Series II Insert/OmniFit® PSL® Microstructured Acetabular Shell

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Post-Approval Study of the ABC and Trident® Systems

Resource links provided by NLM:


Further study details as provided by Stryker Orthopaedics:

Primary Outcome Measures:
  • Component Revision and Complications [ Time Frame: 10 years ] [ Designated as safety issue: Yes ]
    The number of hips in which the study device was removed and replaced with a new component/s is listed. Complications (adverse events) are listed in the adverse event section.


Secondary Outcome Measures:
  • Harris Hip Score [ Time Frame: 3-5 and 10 Years ] [ Designated as safety issue: No ]

    Scores can range from 0 to 100 with 0 being the worst and 100 being the best score. A score of 80-100 is considered good-excellent and a score less than or equal to 79 is considered fair-poor.

    90 - 100 = excellent

    80 - 89 = good

    70 - 79 = fair

    0 - 69 = poor


  • Radiographic Evaluation [ Time Frame: 3-5 and 10 years ] [ Designated as safety issue: No ]
    Failure is defined as progressive femoral radiolucency (RLL) > or = 2mm around entire stem, progressive subsidence > or = 5mm, progressive acetabular radiolucency (RLL) > or = 2 mm around entire cup, or cup migration > or = 3mm.

  • Hip Follow-Up Questionnaire [ Time Frame: 6-10 years ] [ Designated as safety issue: No ]
    A three question follow-up questionnaire was administered annually asking whether the participant is satisfied with the study total hip replacement(THR) (noted as "satisfied" below); whether they have any study hip pain (noted as "no pain" below); and whether they have had any surgery on the study hip during the previous year noted as "no surgery" below).


Enrollment: 413
Study Start Date: March 2003
Study Completion Date: October 2010
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Trident®System
Trident® Ceramic Insert/Trident® AD HA Acetabular Shell
Device: Trident® Ceramic Insert/Trident® AD HA Acetabular Shell
Trident® Ceramic Insert/Trident® AD HA Acetabular Shell
Experimental: ABC System
Alumina Insert/PSL® Microstructured Acetabular Shell or Secur-Fit® HA PSL® Acetabular Shell
Device: Alumina Insert/PSL® Microstructured Acetabular Shell or Secur-Fit® HA PSL® Acetabular Shell
Alumina Insert/PSL® Microstructured Acetabular Shell or Secur-Fit® HA PSL® Acetabular Shell
Active Comparator: Control
OmniFit® Series II Insert/OmniFit® PSL® Microstructured Acetabular Shell
Device: OmniFit® Series II Insert/OmniFit® PSL® Microstructured Acetabular Shell
OmniFit® Series II Insert/OmniFit® PSL® Microstructured Acetabular Shell

Detailed Description:
The ABC/ Trident® study was initiated in 1996 as an FDA IDE pre-market study in the United States for alumina bearing THR. PreMarket Approval (PMA)application was approved in February 3,2003. The Post Approval Study (PAS) involved six surgeon investigators from the original IDE study. Subjects who consented to participate in the Post Approval Study continued to be followed to collect limited patient reported data regarding status of the hip.
  Eligibility

Ages Eligible for Study:   21 Years to 75 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • The individual has signed a Patient Informed Consent (PIC), specific to this study, and approved by the Institutional Review Board (IRB).
  • The individual is between the ages of 21 and 75 years.
  • The individual is not classified as morbidly obese.
  • The individual clinically qualifies for total hip arthroplastic surgery based on physical examination and medical history.
  • The individual is diagnosed with a primary diagnosis of Non-Inflammatory Degenerative Joint Disease (osteoarthritis, traumatic arthritis, avascular necrosis, slipped capital epiphysis, pelvic fracture, femoral fracture, failed fracture fixation or diastrophic variant).
  • The individual does not have an active infection within the affected hip joint.
  • The individual has not had a previous total hip replacement or hip fusion to the affected hip joint.
  • The individual is physically and mentally willing and able to comply with postoperative scheduled clinical and radiographic evaluations and rehabilitation (i.e., not currently being treated for a psychiatric disorder, senile dementia, Alzheimer's disease, presence of alcohol or substance abuse).
  • The individual does not have a neuromuscular or neurosensory deficiency that limits the ability to evaluate the safety and effectiveness of the device.
  • The individual does not have a diagnosed systemic disease that would affect the subject's welfare or overall outcome of the study (i.e., moderate to severe osteoporosis, Paget's disease, renal osteodystrophy), is not immunologically suppressed, nor receiving steroids in excess of physiologic dose requirements.
  • The individual is skeletally mature.
  • The individual is not pregnant.
  • The individual is not a prisoner.
  • The individual has no plans to relocate to another geographic area before the completion of the study.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00960206

Locations
United States, Florida
Orthopaedic Surgery Associates
Boca Raton, Florida, United States, 33435
United States, Georgia
Emory Univeristy
Atlanta, Georgia, United States, 30329
United States, Indiana
Indiana University
Indianapolis, Indiana, United States, 46202
United States, Massachusetts
New England Baptist Hospital
Boston, Massachusetts, United States, 02120
United States, Ohio
Toledo Joint Replacement and Orthopedic Center
Toledo, Ohio, United States, 43623
United States, Pennsylvania
Greater Pittsburgh Orthopaedics Assoc.
Moon Township, Pennsylvania, United States, 15108
Sponsors and Collaborators
Stryker Orthopaedics
Investigators
Study Chair: William Capello, MD Indiana University School of Medicine
Principal Investigator: Benjamin Bierbaum, MD New England Baptist Hospital
Study Chair: James D'Antonio, MD Greater Pittsburgh Orthopaedic Associates
Principal Investigator: James Roberson, MD Emory Orthopaedics Center
Principal Investigator: Scott Siverhus, MD Toledo Joint Replacement and Orthopedic Center
Principal Investigator: Robert Zann, MD Orthopaedic Surgery Associates
  More Information

Responsible Party: Stryker Orthopaedics
ClinicalTrials.gov Identifier: NCT00960206     History of Changes
Other Study ID Numbers: 33/45 
Study First Received: August 5, 2009
Results First Received: June 7, 2013
Last Updated: July 24, 2014
Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on July 26, 2016