Total Hip Replacement (Non-inflammatory)NCT00715143
Post Approval Study: NOVATION Ceramic Articulation Hip System
A study testing Novation Ceramic in people with Total Hip Replacement (Non-inflammatory), run by Exactech at 5 sites in United States.
Trial 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"). Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Total Hip Replacement (Non-inflammatory)
- What is being tested?
- Novation Ceramic
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- 5 sitesUnited States
- Study dates
- Jun 2008to 22 Feb 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- Patient does not meet any of the Exclusion Criteria.
- Patient agrees to participate and sign the Informed Consent Form.
Who cannot join
- Patient will be less than 21 years old at the time of surgery.
- Patient is skeletally immature.
- Patient presents with inflammatory degenerative joint disease.
- Patient has evidence of active infection, but not including asymptomatic urinary tract infection (UTI) if treated with antibiotics preoperatively.
- Patient is female and of child bearing age and is pregnant or whose pregnancy status is unknown.
- Patient has neurological or musculoskeletal disease that may adversely affect gait or weight bearing.
Show all 19Show fewer
- Patient has known presence of active metastatic or neoplastic disease (active is defined as within the past 5 years. Does not include basal cell carcinoma in cases when a subject with this diagnosis has undergone radical excision of the lesion, has pathological proof that the lesion has clean and clear peripheral and deep borders, and the location of the lesion is not near the operative hip or on the affected extremity).
- Patient has poor bone quality (e.g., osteoporosis) where, in the investigator's opinion, there is inadequate bone to support the implant(s).
- Patient has the presence of a previous prosthetic hip replacement device (any type, including THA, surface replacement arthroplasty, endoprosthesis, etc.) in the operative hip joint.
- Patient is known to have presence of a highly communicable disease or diseases that may limit follow-up (e.g., immuno-compromised conditions, hepatitis, active tuberculosis, etc.).
- Patient is a prisoner.
- Patient is obese where obesity is defined as a Body Mass Index (BMI) greater than 35. BMI = Weight (lbs.) ÷ Height (in.)2 x 703
- Patient has neuropathic joints.
- Patient has known allergies to the implant materials.
- Patient is unwilling or unable to comply with postoperative rehabilitation instructions and weight bearing limitations.
- Patient's life expectancy is < 5 years due to chronic diseases such as cancer, congestive heart failure, etc.
- Patient is unwilling or unable (e.g. cases of reduced mental capacity) to return for follow-up as specified by the study protocol over a ten (10) year post-operative follow-up period.
- Patient has reduced mental capability (permanent or temporary) that would prevent following pre-surgical and post-surgical instructions.
- Patient otherwise meets the study criteria but refuses to consent in writing to participate in the study.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Resurgens Orthopaedics
Cumming, Georgia, 30041
Shrock Orthopedic Research
Fort Lauderdale, Florida, 33316
Hampton Roads Orthopaedics & Sports Medicine
Newport News, Virginia, 23606
Tulsa Bone & Joint Associates
Tulsa, Oklahoma, 74146
Fallon Clinic
Worcester, Massachusetts, 01608
About this study
Official title: Post Approval Study: NOVATION Ceramic Articulation Hip System A Multi-Center, Open-Label Study to Evaluate the Mid and Long-Term Safety and Effectiveness of the Exactech NOVATION Ceramic Articulation Hip System
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").
Read the detailed description
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"). Ten (10) years of follow-up data will be collected in this study. The first five (5) years of subject follow-up will involve clinical (Harris Hip Score, adverse events), radiographic, and self-assessment evaluation. The remaining five (5) years of subject follow-up will be accomplished with an outcomes questionnaire that will be completed by the subjects to evaluate the survivorship status of their hip replacement.
- Conditions
- Total Hip Replacement (Non-inflammatory)
- Being tested
- Novation Ceramic
- Keywords
- hip, replacement, ceramic, orthopaedic, joint, degenerative, non-inflammatory, osteoarthritis, avascular necrosis, congenital hip dysplasia, traumatic arthritis
- Medical subject headings
- Osteoarthritis, Osteonecrosis, Hip Dislocation, Congenital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Novation CeramicDevice
Also called Novation
This treatment is the study device (which will be compared to a similar historic control device)
| Study group | Role | What they receive |
|---|---|---|
| All subjects will be receive the Novation Ceramic on Ceramic Articulating Hip System | Other | All subjects will receive the Novation Ceramic on Ceramic Articulating Hip System. Receives: Device: Novation Ceramic |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiographic evaluation of radiolucency
Radiographic analysis
Measured: Immediately post operation, 6 weeks, 6 months, annually 1-5 years
Survivorship of device components
Device Survivorship
Measured: Immediately post operation, 6 weeks, 6 months, annually 1-5 years
Harris Hip Score
Physician assessed outcome
Measured: Immediately post operation, 6 weeks, 6 months, annually 1-5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2008 (estimated)
- Study startJun 2008
- Primary completion22 Feb 2021
- Study completion22 Feb 2021
Why it stopped: Exactech withdrew the PMA associated with the study device due to low market utilization
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Total Hip Replacement (Non-inflammatory)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 126 participants (actual)
Sponsor and investigators
- Lead sponsor
- Exactech
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00715143
- Sponsor's protocol ID
- CR05-005
- Status last verified
- Feb 2015
- First submitted
- 11 Jul 2008
- Last updated
- 31 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post Approval Study: NOVATION Ceramic Articulation Hip System A Multi-Center, Open-Label Study to Evaluate the Mid and Long-Term Safety and Effectiveness of the Exactech NOVATION Ceramic Articulation Hip System
- ClinicalTrials.gov ID
- NCT00715143
- Acronym / sponsor ID
- CR05-005
- Conditions
- Total Hip Replacement (Non-inflammatory)
- Keywords
- hip, replacement, ceramic, orthopaedic, joint, degenerative, non-inflammatory, osteoarthritis
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Exactech withdrew the PMA associated with the study device due to low market utilization
- Enrolment
- 126 participants (actual)
- Lead sponsor
- ExactechIndustry (pharma, biotech, devices)
- Study start
- Jun 2008
- Primary completion
- 22 Feb 2021 (actual)
- Study completion
- 22 Feb 2021 (actual)
- First posted
- 15 Jul 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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").
Detailed description
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"). Ten (10) years of follow-up data will be collected in this study. The first five (5) years of subject follow-up will involve clinical (Harris Hip Score, adverse events), radiographic, and self-assessment evaluation. The remaining five (5) years of subject follow-up will be accomplished with an outcomes questionnaire that will be completed by the subjects to evaluate the survivorship status of their hip replacement.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All subjects will be receive the Novation Ceramic on Ceramic Articulating Hip System | Other | Device: Novation CeramicAll subjects will receive the Novation Ceramic on Ceramic Articulating Hip System. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (19 listed)
- Patient will be less than 21 years old at the time of surgery.
- Patient is skeletally immature.
- Patient presents with inflammatory degenerative joint disease.
- Patient has evidence of active infection, but not including asymptomatic urinary tract infection (UTI) if treated with antibiotics preoperatively.
- Patient is female and of child bearing age and is pregnant or whose pregnancy status is unknown.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Novation CeramicAlso: NovationThis treatment is the study device (which will be compared to a similar historic control device) | Device | All subjects will be receive the Novation Ceramic on Ceramic Articulating Hip System |
Primary outcome
Radiographic evaluation of radiolucency
Time frame: Immediately post operation, 6 weeks, 6 months, annually 1-5 years
Radiographic analysis
Survivorship of device components
Time frame: Immediately post operation, 6 weeks, 6 months, annually 1-5 years
Device Survivorship
Harris Hip Score
Time frame: Immediately post operation, 6 weeks, 6 months, annually 1-5 years
Physician assessed outcome
Results and safety
The study was stopped early (reason given: Exactech withdrew the PMA associated with the study device due to low market utilization). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Novation Ceramic in people with Total Hip Replacement (Non-inflammatory), run by Exactech at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 31 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Exactech withdrew the PMA associated with the study device due to low market utilization). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Radiographic evaluation of radiolucency (time frame: Immediately post operation, 6 weeks, 6 months, annually 1-5 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2022.