Other and Unspecified Injury to Hip and ThighNCT01367899
CONSERVE Plus Post-Approval Study (PAS)
An observational study of Other and Unspecified Injury to Hip and Thigh, run by MicroPort Orthopedics Inc. at 1 site in United States.
Trial summary
The objective of this post-approval study is to provide scientifically valid and reliable evidence that supports claims of longer term safety and effectiveness with regard to Month 120 device survivorship rates. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Other and Unspecified Injury to Hip and Thigh
- How many people
- 199 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2010to Sep 2014
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who have already undergone hip resurfacing in the CONSERVE Plus IDE.
Who may be able to join
- Was previously enrolled in the CONSERVE® Plus IDE as part of the All Enrolled Audited Cohort (N=1366 procedures (1206 patients)) and received the "Original Shell".
- Is willing and able to comply with the study plan and able to understand and sign the Patient Informed Consent Form.
Who cannot join
- Patient is mentally incompetent.
- Patient is a prisoner.
- Patient is an alcohol and/or drug abuser
- Patient has undergone device revision or removal
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Conserve Plus Total Hip Resurfacing System: A Non-Randomized, Multi-center, NewEnrollement Post Approval Study
The objective of this post-approval study is to provide scientifically valid and reliable evidence that supports claims of longer term safety and effectiveness with regard to Month 120 device survivorship rates.
Read the detailed description
This study will evaluate the performance of CONSERVE Plus Hip Resurfacing System under actual conditions of use. Additionally, this study will evaluate the performance of the device in the post approval environment to see if there are any significant changes in device performance as compared to the pre-market IDE Study
- Keywords
- Safety, Efficacy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| CONSERVE® Plus hip resurfacing | Recipients/C Plus (IDE)study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical success at Month 120
Clinical success at Month 120 for each patient will be survivorship, defined as freedom from revision or removal for any aseptic reason and at least "good" function/pain relief defined as Harris Hip Score ≥ 80.
Measured: 10 years
Secondary outcomes (4)
Radiographic outcomes
Secondary measures: radiographic outcomes
Measured: 10 years
Metal Ion (serum)
metal ion (serum) and renal function will also be collected.
Measured: 24 months
Assessment for Adverse Events
Subjects will be assessed for any adverse events during their length of participation
Measured: 10 years
Measurement of Patient Satisfaction
Patient satisfaction as assessed by the SF-12
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2011 (estimated)
- Study startNov 2010
- Primary completionSep 2014
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Other and Unspecified Injury to Hip and ThighStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 199 participants (actual)
Sponsor and investigators
- Lead sponsor
- MicroPort Orthopedics Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michael Bolognesi, MD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01367899
- Sponsor's protocol ID
- 09-LJH-002
- Status last verified
- Oct 2014
- First submitted
- 2 May 2011
- Last updated
- 28 Oct 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Conserve Plus Total Hip Resurfacing System: A Non-Randomized, Multi-center, NewEnrollement Post Approval Study
- ClinicalTrials.gov ID
- NCT01367899
- Acronym / sponsor ID
- 09-LJH-002
- Keywords
- Safety, Efficacy
- Study type
- Observational
- Recruitment status
- Terminated
- Enrolment
- 199 participants (actual)
- Lead sponsor
- MicroPort Orthopedics Inc.Industry (pharma, biotech, devices)
- Study start
- Nov 2010
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 7 Jun 2011 (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 objective of this post-approval study is to provide scientifically valid and reliable evidence that supports claims of longer term safety and effectiveness with regard to Month 120 device survivorship rates.
Detailed description
This study will evaluate the performance of CONSERVE Plus Hip Resurfacing System under actual conditions of use. Additionally, this study will evaluate the performance of the device in the post approval environment to see if there are any significant changes in device performance as compared to the pre-market IDE Study
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CONSERVE® Plus hip resurfacing | – | –Recipients/C Plus (IDE)study |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who have already undergone hip resurfacing in the CONSERVE Plus IDE.
Key inclusion criteria (2 listed)
- Was previously enrolled in the CONSERVE® Plus IDE as part of the All Enrolled Audited Cohort (N=1366 procedures (1206 patients)) and received the "Original Shell".
- Is willing and able to comply with the study plan and able to understand and sign the Patient Informed Consent Form.
Key exclusion criteria (4 listed)
- Patient is mentally incompetent.
- Patient is a prisoner.
- Patient is an alcohol and/or drug abuser
- Patient has undergone device revision or removal
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Clinical success at Month 120
Time frame: 10 years
Clinical success at Month 120 for each patient will be survivorship, defined as freedom from revision or removal for any aseptic reason and at least "good" function/pain relief defined as Harris Hip Score ≥ 80.
4 secondary outcomes
Radiographic outcomes
Time frame: 10 years
Metal Ion (serum)
Time frame: 24 months
Assessment for Adverse Events
Time frame: 10 years
Measurement of Patient Satisfaction
Time frame: 10 years
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2014.
Related trials for Other and Unspecified Injury to Hip and Thigh
Recruiting
Exercise and Patient Education for Patients With Lateral Hip Pain
Gluteal Tendinitis, Greater Trochanteric Pain Syndrome
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.
Michael Bolognesi, MD principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Other and Unspecified Injury to Hip and Thigh, run by MicroPort Orthopedics Inc. at 1 site 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 2 inclusion and 4 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 28 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. 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?
Clinical success at Month 120 (time frame: 10 years). 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 28 Oct 2014.