||P050039 / PAS002
|Current Plan Approved
OSB Lead-Novation PAS
|General Study Protocol Parameters
Prospective & Retrospective Study
New Data Collection
|Detailed Study Protocol Parameters
|Study Design Description
multi-center, open-label clinical study. Prospective and retrospective enrollment
|Study Population Description
Patients who are scheduled to undergo total hip arthroplasty with a hard bearing
prosthesis should be screened for enrollment in this post approval study. Likewise,
patients who previously underwent total hip arthroplasty with the NOVATION Ceramic
AHS with one of the femoral stems allowed in this protocol may be screened for
enrollment. Screening of patients who previously received the device should include any
patients who have subsequently undergone revision, as the events leading to the revision
will provide valuable information about the safety and effectiveness of the device.
Patients who meet all inclusion criteria and no exclusion criteria will be asked to participate in the study.
Up to ten (10) centers will participate in this study.
The objective of this study is to gather supplementary long-term information regarding
the safety and efficacy of the NOVATION Ceramic AHS.
¿ Survivorship of the NOVATION Ceramic AHS at 2, 5, and 10 years follow-up
¿ Patient success (defined by inclusion of all the criteria below) will be provided
annually out to 5 years follow-up:
o Absence of revision
o Total Harris Hip Score ≥ 80
o No complete radiolucencies as determined by radiographic evaluation of 3
views: acetabular AP view (3 zones1), femoral stem AP view (7 Gruen2
zones), and femoral stem lateral view (7 Gruen zones).
Complete radiolucency is defined to be present if there is any radiolucency
present in all the zones comprising that view. Absence of complete
radiolucency is defined to be present if none of these three views have
A non-successful patient outcome will be characterized as one or more of the
o Revision of any device component of the NOVATION Ceramic AHS;
o Total Harris Hip Score less than 80; or
o Complete radiolucencies as defined above.
● Harris Hip Score, SF-12, and radiographic findings will be evaluated, as per the
Study Procedures section, and reported annually until all patients have reached 5
years of follow-up.
¿ Complication rates, including incidence, severity, and relation to device.
|Follow-up Visits and Length of Follow-up
Subjects shall have visits completed within the following allowable windows:
Visit Visit Window
Preop (baseline) Within 2 months prior to surgery
6 Week +/- 2 weeks
6 Month +/- 1 month
Annual Visits (Years 1-5) +/- 2 months
Annual Questionnaires (Years 6-10) +/- 2 months