Trident® Tritanium™ Acetabular Shell Revision Study

NCT00535626 | Completed Results

• 1 other identifier: 61
• Study Type: interventional
• Target: 241
• Locations: 1 country
• Sites: 15

Brief Summary

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

Conditions

Arthroplasty, Replacement, Hip

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Change in Harris Hip Score (HHS) From Pre-operative to Post-operative Visits

  pre-op, 3 month, 1, 2, 3, 4, 5 years

• Change in SF-36 From Pre-operative to Post-operative Visits

  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

  3 month, 1, 2, 3, 4, 5 years

• Radiographic Outcomes: Migration of the Acetabular Shell Greater Than 5 mm in Any Direction

  3 month, 1, 2, 3, 4, 5 years

• Change in Lower Extremity Activity Scale (LEAS) From Pre-operative to Post-operative

  pre-op, 3 month, 1, 2, 3, 4, 5 years

Study Arms (1)

Trident® Tritanium™ Acetabular Shell

OTHER

Trident® Tritanium™ Acetabular Shell used in revision total hip replacement

Device: Trident® Tritanium™ Acetabular Shell

Interventions

Trident® Tritanium™ Acetabular Shell DEVICE

Trident® Tritanium™ Acetabular Shell

Trident® Tritanium™ Acetabular Shell

Eligibility Criteria

• Age: 21 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Stryker Orthopaedics: lead

Study Sites (15)

Orthopedic Specialty Institute

Orange, California, 92868, United States

Location

Heekin Institute for Orthopedic Research, Inc.

Jacksonville, Florida, 32204, United States

Location

Cedars Medical Center

Miami, Florida, 33136, United States

Location

Illinois Bone & Joint Institute

Glenview, Illinois, 60025, United States

Location

University of Louisville, 201 Abraham Flexner Way, Suite 100

Louisville, Kentucky, 40202, United States

Location

New England Baptist Hospital

Boston, Massachusetts, 02120, United States

Location

St Joseph Mercy Hospital

Ypsilanti, Michigan, 48197, United States

Location

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

Location

NYU Hospital for Joint Diseases

New York, New York, 10003, United States

Location

Hospital for Special Surgery

New York, New York, 10021, United States

Location

Crystal Clinic

Akron, Ohio, 44333, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

The Methodist Hospital

Houston, Texas, 77030, United States

Location

Scott & White Memorial Hospital

Temple, Texas, 76508, United States

Location

Rockwood Clinic

Spokane, Washington, 99202, United States

Location

Results Point of Contact

• Title: Director, Clinical Operations
• Organization: Stryker Orthopedics

ellen.axelson@stryker.com

201-831-5401

Study Officials

• Arthur Malkani, MD

  University of Louisville

  STUDY CHAIR

• Michael Masini, MD

  St Joseph Mercy Hospital

  PRINCIPAL INVESTIGATOR

• Daniel Ward, MD

  New England Baptist Hospital

  PRINCIPAL INVESTIGATOR

• Benjamin Bierbaum, 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

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 24, 2007
• First Posted: September 26, 2007
• Study Start: November 1, 2006
• Primary Completion: September 1, 2016
• Study Completion: September 1, 2016
• Last Updated: November 20, 2017
• Results First Posted: November 20, 2017

Record last verified: 2017-11

Locations

US (15)