ABC/Trident® Ceramic Post Approval Study

Arthroplasty, Replacement, Hip Clinical Trial

Official title:

Post-Approval Study of the ABC and Trident® Systems

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00960206
• Other study ID #: 33/45
• Status: Completed
• Phase: N/A
• First received: August 5, 2009
• Last updated: July 24, 2014
• Start date: March 2003
• Est. completion date: October 2010

Study information

• Verified date: July 2014
• Source: Stryker Orthopaedics
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of the Post Approval Study of the ABC and Trident® systems is to continue to demonstrate the safety and efficacy of the alumina-on-alumina bearing surfaces combined with the appropriate shell in a cementless application.

Description:

The ABC/ Trident® study was initiated in 1996 as an FDA IDE pre-market study in the United States for alumina bearing THR. PreMarket Approval (PMA)application was approved in February 3,2003. The Post Approval Study (PAS) involved six surgeon investigators from the original IDE study. Subjects who consented to participate in the Post Approval Study continued to be followed to collect limited patient reported data regarding status of the hip.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 413
• Est. completion date: October 2010
• Est. primary completion date: October 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years to 75 Years

Eligibility

Inclusion Criteria:

• The individual has signed a Patient Informed Consent (PIC), specific to this study, and approved by the Institutional Review Board (IRB).

• The individual is between the ages of 21 and 75 years.

• The individual is not classified as morbidly obese.

• The individual clinically qualifies for total hip arthroplastic surgery based on physical examination and medical history.

• The individual is diagnosed with a primary diagnosis of Non-Inflammatory Degenerative Joint Disease (osteoarthritis, traumatic arthritis, avascular necrosis, slipped capital epiphysis, pelvic fracture, femoral fracture, failed fracture fixation or diastrophic variant).

• The individual does not have an active infection within the affected hip joint.

• The individual has not had a previous total hip replacement or hip fusion to the affected hip joint.

• The individual is physically and mentally willing and able to comply with postoperative scheduled clinical and radiographic evaluations and rehabilitation (i.e., not currently being treated for a psychiatric disorder, senile dementia, Alzheimer's disease, presence of alcohol or substance abuse).

• The individual does not have a neuromuscular or neurosensory deficiency that limits the ability to evaluate the safety and effectiveness of the device.

• The individual does not have a diagnosed systemic disease that would affect the subject's welfare or overall outcome of the study (i.e., moderate to severe osteoporosis, Paget's disease, renal osteodystrophy), is not immunologically suppressed, nor receiving steroids in excess of physiologic dose requirements.

• The individual is skeletally mature.

• The individual is not pregnant.

• The individual is not a prisoner.

• The individual has no plans to relocate to another geographic area before the completion of the study.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arthroplasty, Replacement, Hip

Intervention

Device:
• Trident® Ceramic Insert/Trident® AD HA Acetabular Shell
Trident® Ceramic Insert/Trident® AD HA Acetabular Shell
• Alumina Insert/PSL® Microstructured Acetabular Shell or Secur-Fit® HA PSL® Acetabular Shell
Alumina Insert/PSL® Microstructured Acetabular Shell or Secur-Fit® HA PSL® Acetabular Shell
• OmniFit® Series II Insert/OmniFit® PSL® Microstructured Acetabular Shell
OmniFit® Series II Insert/OmniFit® PSL® Microstructured Acetabular Shell

Locations

Country	Name	City	State
United States	Emory Univeristy	Atlanta	Georgia
United States	Orthopaedic Surgery Associates	Boca Raton	Florida
United States	New England Baptist Hospital	Boston	Massachusetts
United States	Indiana University	Indianapolis	Indiana
United States	Greater Pittsburgh Orthopaedics Assoc.	Moon Township	Pennsylvania
United States	Toledo Joint Replacement and Orthopedic Center	Toledo	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Stryker Orthopaedics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Component Revision and Complications	The number of hips in which the study device was removed and replaced with a new component/s is listed. Complications (adverse events) are listed in the adverse event section.	10 years	Yes
Secondary	Harris Hip Score	Scores can range from 0 to 100 with 0 being the worst and 100 being the best score. A score of 80-100 is considered good-excellent and a score less than or equal to 79 is considered fair-poor.; 90 - 100 = excellent; 80 - 89 = good; 70 - 79 = fair; 0 - 69 = poor	3-5 and 10 Years	No
Secondary	Radiographic Evaluation	Failure is defined as progressive femoral radiolucency (RLL) > or = 2mm around entire stem, progressive subsidence > or = 5mm, progressive acetabular radiolucency (RLL) > or = 2 mm around entire cup, or cup migration > or = 3mm.	3-5 and 10 years	No
Secondary	Hip Follow-Up Questionnaire	A three question follow-up questionnaire was administered annually asking whether the participant is satisfied with the study total hip replacement(THR) (noted as "satisfied" below); whether they have any study hip pain (noted as "no pain" below); and whether they have had any surgery on the study hip during the previous year noted as "no surgery" below).	6-10 years	No