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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00535626
Other study ID # 61
Secondary ID
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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