Clinical trial NCT00535626: Trident® Tritanium™ Acetabular Shell Revision Study
Official title: A Post-market, Non-randomized, Open Label, Multi-center Clinical Study of the Trident Tritanium Acetabular Shell
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Arthroplasty, Replacement, Hip
Lead sponsor: Stryker Orthopaedics
Sponsor class: INDUSTRY
First posted: 2007-09-26
Enrollment: 241
Sex: ALL
Minimum age (years): 21
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Number of Hips Requiring Revision or Pending Revision of the Acetabular Shell (as Defined by Radiographic Parameters) Due to Instability or Lack of Fixation
timeFrame: 5 years post-operative
Secondary outcomes:
measure: Change in Harris Hip Score (HHS) From Pre-operative to Post-operative Visits
timeFrame: pre-op, 3 month, 1, 2, 3, 4, 5 years
measure: Change in SF-36 From Pre-operative to Post-operative Visits
timeFrame: pre-op, 3 month, 1, 2, 3, 4, 5 years
measure: Radiographic Outcomes: Radiolucency (RLL) Around the Acetabular Shell is Greater Than 2 mm in All Zones
timeFrame: 3 month, 1, 2, 3, 4, 5 years
measure: Radiographic Outcomes: Migration of the Acetabular Shell Greater Than 5 mm in Any Direction
timeFrame: 3 month, 1, 2, 3, 4, 5 years
measure: Change in Lower Extremity Activity Scale (LEAS) From Pre-operative to Post-operative
timeFrame: pre-op, 3 month, 1, 2, 3, 4, 5 years
Other outcomes:
Locations:
city: Orange
country: United States
facility: Orthopedic Specialty Institute
state: California
city: Jacksonville
country: United States
facility: Heekin Institute for Orthopedic Research, Inc.
state: Florida
city: Miami
country: United States
facility: Cedars Medical Center
state: Florida
city: Glenview
country: United States
facility: Illinois Bone & Joint Institute
state: Illinois
city: Louisville
country: United States
facility: University of Louisville, 201 Abraham Flexner Way, Suite 100
state: Kentucky
city: Boston
country: United States
facility: New England Baptist Hospital
state: Massachusetts
city: Ypsilanti
country: United States
facility: St Joseph Mercy Hospital
state: Michigan
city: Lebanon
country: United States
facility: Dartmouth-Hitchcock Medical Center
state: New Hampshire
city: New York
country: United States
facility: NYU Hospital for Joint Diseases
state: New York
city: New York
country: United States
facility: Hospital for Special Surgery
state: New York
city: Akron
country: United States
facility: Crystal Clinic
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Houston
country: United States
facility: The Methodist Hospital
state: Texas
city: Temple
country: United States
facility: Scott & White Memorial Hospital
state: Texas
city: Spokane
country: United States
facility: Rockwood Clinic
state: Washington
Study officials:
affiliation: University of Louisville
name: Arthur Malkani, MD
role: STUDY_CHAIR
affiliation: St Joseph Mercy Hospital
name: Michael Masini, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: New England Baptist Hospital
name: Daniel Ward, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: New England Baptist Hospital
name: Benjamin Bierbaum, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Scott & White Memorial Hospital
name: Kirby Hitt, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Crystal Clinic
name: Kenneth Greene, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Illinois Bone & Joint Institute
name: Jim Kudrna, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Dartmouth-Hitchcock Medical Center
name: Ivan Tomek, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Dartmouth-Hitchcock Medical Center
name: Stephen Kantor, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Orthopedic Specialty Institute
name: Steven Barnett, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: The Cleveland Clinic
name: Carlos Higuera, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: NYU Hospital for Joint Diseases
name: Joseph Zuckerman, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: NYU Hospital for Joint Diseases
name: Fredrick Jaffe, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: The Methodist Hospital Research Institute
name: Stephen Incavo, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Rockwood Clinic
name: Timothy Lovell, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Cedars Medical Center
name: Sean Scully, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital for Special Surgery, New York
name: Amar Ranawat, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital for Special Surgery, New York
name: Geoffrey Westrich, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Heekin Institute for Orthopedic Research, Inc.
name: R D Heekin, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Scott & White Memorial Hospital
name: Bryce Allen, MD
role: PRINCIPAL_INVESTIGATOR
References: