TerminatedNot Applicable

Post Approval Study: NOVATION Ceramic Articulation Hip System

Stopped: Exactech withdrew the PMA associated with the study device due to low market utilization

United States126 participantsStarted 2008-06

Plain-language summary

The purpose of this study is to collect and evaluate long-term safety and effectiveness data on the Exactech® NOVATION ™ Ceramic Articulation Hip System ("NOVATION ™ Ceramic AHS").

Who can participate

Age range

21 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Patient is undergoing primary hip surgery for symptomatic Non-inflammatory Degenerative Joint Disease (NIDJD). Composite diagnosis of NIDJD includes osteo/ degenerative arthritis, traumatic arthritis, congenital hip dysplasia and avascular necrosis.
. Patient is 21 years of age or older at the time of surgery.
. Patient is skeletally mature (tibial and femoral epiphyses are closed).
. Patient is willing and able to return for follow-up as specified by the study protocol over a ten (10) year post-operative follow-up period; including 5 years of in-clinic visits followed by 5 years of mail-in questionnaire follow-up.
. Patient is female and of childbearing age, for whom a negative urine pregnancy test is obtained immediately prior to surgery.

Exclusion criteria

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Radiographic evaluation of radiolucency

Timeframe: Immediately post operation, 6 weeks, 6 months, annually 1-5 years

Survivorship of device components

Timeframe: Immediately post operation, 6 weeks, 6 months, annually 1-5 years

Harris Hip Score

Timeframe: Immediately post operation, 6 weeks, 6 months, annually 1-5 years

Trial details

NCT IDNCT00715143

SponsorExactech

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2021-02-22

View on ClinicalTrials.gov More Total Hip Replacement (Non-inflammatory) trials

Who can participate

Age range

21 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Patient is undergoing primary hip surgery for symptomatic Non-inflammatory Degenerative Joint Disease (NIDJD). Composite diagnosis of NIDJD includes osteo/ degenerative arthritis, traumatic arthritis, congenital hip dysplasia and avascular necrosis.
. Patient is 21 years of age or older at the time of surgery.
. Patient is skeletally mature (tibial and femoral epiphyses are closed).
. Patient is willing and able to return for follow-up as specified by the study protocol over a ten (10) year post-operative follow-up period; including 5 years of in-clinic visits followed by 5 years of mail-in questionnaire follow-up.
. Patient is female and of childbearing age, for whom a negative urine pregnancy test is obtained immediately prior to surgery.

Exclusion criteria

What they're measuring

Radiographic evaluation of radiolucency

Timeframe: Immediately post operation, 6 weeks, 6 months, annually 1-5 years

Survivorship of device components

Timeframe: Immediately post operation, 6 weeks, 6 months, annually 1-5 years

Harris Hip Score

Timeframe: Immediately post operation, 6 weeks, 6 months, annually 1-5 years