Trident® Tritanium™ Acetabular Shell Revision Study

A Post-market, Non-randomized, Open Label, Multi-center Clinical Study of the Trident Tritanium Acetabular Shell

The purpose of this study is to evaluate a hip implant system used when a previous hip replacement surgery has failed.

Study Overview

• Status: Completed
• Conditions: Arthroplasty, Replacement, Hip
• Intervention / Treatment: Device: Trident® Tritanium™ Acetabular Shell

Detailed Description

Total hip replacement is considered to be a very successful surgical procedure for the treatment of degenerative joint disease. Clinical results for cementless acetabular components have demonstrated excellent long-term fixation of these devices. However, so called 'first generation' cementless acetabular components have not had similar success rates. In these cases the acetabular component is often revised due to loosening, wear or infection.

Revision hip arthroplasty also becomes a challenge as patients often present with severe bone loss and poor bone quality. This can lead to compromised initial stability, which in turn leads to lack of long-term fixation and failure. Acetabular revision with a cementless component has shown improved results over cemented fixation.

Radiographic evaluation of the Trident® Tritanium™ Acetabular Shell will provide valuable early to intermediate information that may help predict the long-term success of this new system.

It is the intention of this study to closely follow subjects that have undergone revision hip replacement with regard to implant survivorship, signs of radiographic loosening, subjects' function evaluated through Harris Hip Score and Lower Extremity Activity Scale, subject quality of life through SF-36 and adverse events.

The primary efficacy hypothesis is that the rate of revision or pending revision (as defined by radiographic parameters) due to instability or lack of fixation for the Trident® Tritanium™ Acetabular Shell will be less than 10% at 5 years.

• Study Type: Interventional
• Enrollment (Actual): 241
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Orange, California, United States, 92868
      • Orthopedic Specialty Institute
  • Florida
    • Jacksonville, Florida, United States, 32204
      • Heekin Institute for Orthopedic Research, Inc.
    • Miami, Florida, United States, 33136
      • Cedars Medical Center
  • Illinois
    • Glenview, Illinois, United States, 60025
      • Illinois Bone & Joint Institute
  • Kentucky
    • Louisville, Kentucky, United States, 40202
      • University of Louisville, 201 Abraham Flexner Way, Suite 100
  • Massachusetts
    • Boston, Massachusetts, United States, 02120
      • New England Baptist Hospital
  • Michigan
    • Ypsilanti, Michigan, United States, 48197
      • St Joseph Mercy Hospital
  • New Hampshire
    • Lebanon, New Hampshire, United States, 03756
      • Dartmouth-Hitchcock Medical Center
  • New York
    • New York, New York, United States, 10021
      • Hospital for Special Surgery
    • New York, New York, United States, 10003
      • NYU Hospital for Joint Diseases
  • Ohio
    • Akron, Ohio, United States, 44333
      • Crystal Clinic
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic
  • Texas
    • Houston, Texas, United States, 77030
      • The Methodist Hospital
    • Temple, Texas, United States, 76508
      • Scott & White Memorial Hospital
  • Washington
    • Spokane, Washington, United States, 99202
      • Rockwood Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Males and non-pregnant females, 21-85 years of age at the time of surgery.
2. Patient is a candidate for a revision of a failed acetabular component with a cementless acetabular component.
3. Patient has signed an IRB approved study consent form.
4. Patient is willing and able to comply with postoperative requirements including postoperative weight bearing restrictions and self-evaluations.

Exclusion Criteria:

1. Patient is morbidly obese, BMI > 40.
2. Patient has a systemic or metabolic bone disorder leading to progressive bone deterioration.
3. Patient is immunologically compromised or receiving steroids in excess of normal physiological requirements (> 30 days).
4. Patient's bone stock is compromised by disease or infection which cannot provide adequate support and/or fixation to the prosthesis.
5. Patient has an active or suspected latent infection on or about the hip joint.
6. Patient is a prisoner.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Trident® Tritanium™ Acetabular Shell; Trident® Tritanium™ Acetabular Shell used in revision total hip replacement	Device: Trident® Tritanium™ Acetabular Shell; Trident® Tritanium™ Acetabular Shell

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of Hips Requiring Revision or Pending Revision of the Acetabular Shell (as Defined by Radiographic Parameters) Due to Instability or Lack of Fixation	5 years post-operative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Harris Hip Score (HHS) From Pre-operative to Post-operative Visits	The change in HHS is reported by comparing the mean pre-operative, 3-month, 1, 2, 3, 4, and 5 year post-operative scores. Scores can range from 0 to 100, with 0 being the worst and 100 being the best score. 90-100 = excellent, 80-89 = good, 70-79 = fair, 0-69 = poor.	pre-op, 3 month, 1, 2, 3, 4, 5 years
Change in SF-36 From Pre-operative to Post-operative Visits	The change in SF-36 is reported by comparing the mean preoperative, 3 month, 1, 2, 3, 4, and 5 year scores. The SF-36 Health Survey is a 36 item patient-completed questionnaire to measure general health and well-being. It includes a physical and mental status component score; each ranging from 0-100. Low values represent a poor health state and high values represent a good health state.	pre-op, 3 month, 1, 2, 3, 4, 5 years
Radiographic Outcomes: Radiolucency (RLL) Around the Acetabular Shell is Greater Than 2 mm in All Zones	Defined as a lucent area seen parallel and in close proximity to the device at the prosthesis/bone interface encompassing at least 50% of the zone, and at least 1 mm or greater in width. May be accompanied by a radiopaque (reactive) line. Assessed for each of the three modified DeLee Charnley zones.	3 month, 1, 2, 3, 4, 5 years
Radiographic Outcomes: Migration of the Acetabular Shell Greater Than 5 mm in Any Direction	Defined as the measurable change in the acetabular shell position relative to reproducible bony landmarks.	3 month, 1, 2, 3, 4, 5 years
Change in Lower Extremity Activity Scale (LEAS) From Pre-operative to Post-operative	The change in LEAS is reported by comparing the mean pre-operative, 3 month, 1, 2, 3, 4, and 5 year scores. The LEAS is completed by the participant to assess activity level. Activity levels were ordered in terms of intensity from 1 to 18, with 18 indicating the highest activity level.	pre-op, 3 month, 1, 2, 3, 4, 5 years

Collaborators and Investigators

• Sponsor: Stryker Orthopaedics
• Investigators: Principal Investigator: Benjamin Bierbaum, MD, New England Baptist Hospital; Study Chair: Arthur Malkani, MD, University of Louisville; Principal Investigator: Michael Masini, MD, St Joseph Mercy Hospital; Principal Investigator: Daniel Ward, MD, New England Baptist Hospital; Principal Investigator: Kirby Hitt, MD, Scott & White Memorial Hospital; Principal Investigator: Kenneth Greene, MD, Crystal Clinic; Principal Investigator: Jim Kudrna, MD, Illinois Bone & Joint Institute; Principal Investigator: Ivan Tomek, MD, Dartmouth-Hitchcock Medical Center; Principal Investigator: Stephen Kantor, MD, Dartmouth-Hitchcock Medical Center; Principal Investigator: Steven Barnett, MD, Orthopedic Specialty Institute; Principal Investigator: Carlos Higuera, MD, The Cleveland Clinic; Principal Investigator: Joseph Zuckerman, MD, NYU Hospital for Joint Diseases; Principal Investigator: Fredrick Jaffe, MD, NYU Hospital for Joint Diseases; Principal Investigator: Stephen Incavo, MD, The Methodist Hospital Research Institute; Principal Investigator: Timothy Lovell, MD, Rockwood Clinic; Principal Investigator: Sean Scully, MD, Cedars Medical Center; Principal Investigator: Amar Ranawat, MD, Hospital for Special Surgery, New York; Principal Investigator: Geoffrey Westrich, MD, Hospital for Special Surgery, New York; Principal Investigator: R D Heekin, MD, Heekin Institute for Orthopedic Research, Inc.; Principal Investigator: Bryce Allen, MD, Scott & White Memorial Hospital

Study record dates

Study Major Dates

• Study Start: November 1, 2006
• Primary Completion (Actual): September 1, 2016
• Study Completion (Actual): September 1, 2016

Study Registration Dates

• First Submitted: September 24, 2007
• First Submitted That Met QC Criteria: September 24, 2007
• First Posted (Estimate): September 26, 2007

Study Record Updates

• Last Update Posted (Actual): November 20, 2017
• Last Update Submitted That Met QC Criteria: November 17, 2017
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: 61