Trident® Tritanium™ Acetabular Shell Revision Study

Arthroplasty, Replacement, Hip Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00535626
• Other study ID #: 61
• Status: Completed
• Phase: N/A
• First received: September 24, 2007
• Last updated: November 17, 2017
• Start date: November 2006
• Est. completion date: September 2016

Study information

• Verified date: November 2017
• Source: Stryker Orthopaedics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 241
• Est. completion date: September 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Arthroplasty, Replacement, Hip

Intervention

Device:
• Trident® Tritanium™ Acetabular Shell
Trident® Tritanium™ Acetabular Shell

Locations

Country	Name	City	State
United States	Crystal Clinic	Akron	Ohio
United States	New England Baptist Hospital	Boston	Massachusetts
United States	Cleveland Clinic	Cleveland	Ohio
United States	Illinois Bone & Joint Institute	Glenview	Illinois
United States	The Methodist Hospital	Houston	Texas
United States	Heekin Institute for Orthopedic Research, Inc.	Jacksonville	Florida
United States	Dartmouth-Hitchcock Medical Center	Lebanon	New Hampshire
United States	University of Louisville, 201 Abraham Flexner Way, Suite 100	Louisville	Kentucky
United States	Cedars Medical Center	Miami	Florida
United States	Hospital for Special Surgery	New York	New York
United States	NYU Hospital for Joint Diseases	New York	New York
United States	Orthopedic Specialty Institute	Orange	California
United States	Rockwood Clinic	Spokane	Washington
United States	Scott & White Memorial Hospital	Temple	Texas
United States	St Joseph Mercy Hospital	Ypsilanti	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Stryker Orthopaedics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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