Clinical trial NCT01754155: A Prospective Radiostereometric Analysis and Clinical Evaluation of the Zimmer® Continuum® Acetabular Cup With Vitamin E Stabilized Polyethylene
Official title: A Prospective Radiostereometric Analysis and Clinical Evaluation of the Zimmer® Continuum® Acetabular Cup With Vitamin E Stabilized Polyethylene
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Radiostereometric Analysis
Vitamin E Liner
Zimmer® Continuum® Acetabular Cup
Keywords: Vitamin E
Zimmer
RSA
Radiostereometric Analysis
Lead sponsor: Central DuPage Hospital
Sponsor class: OTHER
Collaborators: name: Zimmer Biomet
name: Halifax Biomedical Inc.
First posted: 2012-12-21
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to use Radiostereometric Analysis (RSA) and clinical outcome measures to evaluate early, post-operative implant stability, post-operative implant fixation, clinical performance, and in-vivo wear of the Zimmer® Continuum® Cup with vitamin E stabilized polyethylene.


Eligibility criteria: Inclusion Criteria:

* Symptomatic osteoarthritis of the hip indicating surgical intervention
* Scheduled to undergo an uncemented total hip arthroplasty (THA)
* Patients between the ages of 18 and 65, inclusive
* Ability to give informed consent
* Patients will be available for follow-up for a minimum of 2 years after surgery

Exclusion Criteria:

* Patients less than 18 years of age, or older than 65 years of age.
* Post-traumatic arthritis in the affected hip
* Rheumatoid arthritis in the affected hip
* Hip dysplasia in the affected hip
* Prior arthroplasty of the affected hip
* Active or prior infection of the affected hip
* Morbid obesity (BMI \> 35)
* Medical condition precluding major surgery
* Severe osteoporosis or osteopenia
* Neuromuscular impairment
* Patients with known allergy to metals
* Pregnancy
* Patients with compromised kidney function
* Patient is immuno-suppressed
* Patients that require a femoral head less than 32 mm or greater than 40mm.

Primary outcomes:
measure: Assessing the Continuum® Cup for adequate fixation to the underlying bone as measured by migration and tilt
timeFrame: 2 years
measure: Assessing the migration pattern of the Continuum® Cup
timeFrame: 2 years
measure: Determining a correlation between radiolucent lines (RLLs) measured by Charnley-DeLee Zone Analyses and migration characteristics using RSA
timeFrame: 2 years
measure: Determine if inducible displacement is indicative of adequate fixation
timeFrame: 2 years
measure: Assess the health status and functional outcome of patients with the Continuum® Cup
timeFrame: 2 years
measure: Assess the wear rate of the Vitamin E polyethylene with a ceramic femoral head
timeFrame: 2 years
measure: Determine if the wear rate of the Vitamin E liner is the same in-vivo as it is in simulation testing
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Winfield
country: United States
facility: Central DuPage Hospital
state: Illinois
Study officials:
affiliation: Central DuPage Hospital
name: Scott Sporer, MD
role: PRINCIPAL_INVESTIGATOR
References: