Trident® Tritanium™ Acetabular Shell Revision Study

Stryker Orthopaedics241 enrolled

Overview

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

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

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

241

Conditions

Arthroplasty, Replacement, Hip

Interventions

Trident® Tritanium™ Acetabular ShellDEVICE

Trident® Tritanium™ Acetabular Shell

Eligibility

Sex: ALLMin age: 21 YearsMax age: 85 Years

Medical Language ↔ Plain English

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.

Locations (15)

Orthopedic Specialty Institute

Orange, California, United States

Heekin Institute for Orthopedic Research, Inc.

Jacksonville, Florida, United States

Outcomes

Primary Outcomes

Number of Hips Requiring Revision or Pending Revision of the Acetabular Shell (as Defined by Radiographic Parameters) Due to Instability or Lack of Fixation

Time frame: 5 years post-operative

Secondary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 3 month, 1, 2, 3, 4, 5 years

Data from ClinicalTrials.gov

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