OsteoarthritisNCT00867256
Cormet Large Diameter Metal on Metal (LDMOM) Total Hip System (G030265)
A study testing Large Diameter Metal on Metal in people with Osteoarthritis and Rheumatoid Arthritis, run by Corin.
Trial summary
To demonstrate the safety and efficacy of the Cormet Large Diameter Metal on Metal (LDMOM) Total Hip System using a composite clinical success (CCS) primary endpoint. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteoarthritis, Rheumatoid Arthritis, Avascular Necrosis
- What is being tested?
- Large Diameter Metal on Metal
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 195 participants
- Where
- No sites listed yet
- Study dates
- 31 Mar 2004to 27 Apr 2009
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient:
- is skeletally mature
- is mentally capable of completing follow-up forms
- will be available for follow-up out to 2 years
- has a preoperative Harris Hip Score <70 points
- has been deemed a candidate for hip replacement by diagnosis of the investigator.
Who cannot join
- Patient:
- has active joint infection
- has had previous hip arthrodesis (fusion)
- has had above knee amputation of either extremity
- has active neoplastic disease
- has a need for a structural bone graft in the operative side
Show all 13Show fewer
- has an ipsilateral hemi or total arthroplasty of any kind
- has a nonunion or malunion of any part of the femur on operative side
- has severe osteoporosis of the pelvis and/or femur as noted on standard radiograph
- is a prisoner
- is pregnant
- is known to be allergic to implant materials
- is morbidly obese.
About this study
Official title: Large Diameter Metal-on-Metal Total Hip System IDE
To demonstrate the safety and efficacy of the Cormet Large Diameter Metal on Metal (LDMOM) Total Hip System using a composite clinical success (CCS) primary endpoint.
Read the detailed description
The results from the Cormet Large Diameter Metal on Metal (LDMOM) Total Hip System cohort will be compared to the historical results from a ceramic on ceramic (CoC) hip system cohort. The primary endpoint clinical composite success (CCS) criterion at 24 months postoperative is based on a Harris Hip Score ≥ 80 and the absence of any revision,replacement, or modification of any study component.
- Conditions
- Osteoarthritis, Rheumatoid Arthritis, Avascular Necrosis
- Being tested
- Large Diameter Metal on Metal
- Keywords
- arthritis
- Medical subject headings
- Osteoarthritis, Arthritis, Rheumatoid, Osteonecrosis, Arthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Large Diameter Metal on MetalDevice
| Study group | Role | What they receive |
|---|---|---|
| Large Diameter Metal on Metal | Experimental | Not described Receives: Device: Large Diameter Metal on Metal |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite clinical criterion
Based on Harris Hip Score ≥ 80, and absence of any revision, replacement, or modification of any study component
Measured: 24-months postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2009 (estimated)
- Study start31 Mar 2004
- Primary completion23 Oct 2006
- Study completion27 Apr 2009
Why it stopped: terminated for business reasons; study closed.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoarthritisStudies 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
- 195 participants (actual)
Sponsor and investigators
- Lead sponsor
- Corin
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Giulia Carli, Study director, Corin Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00867256
- Sponsor's protocol ID
- LDMOM
- Status last verified
- Sep 2023
- First submitted
- 7 Apr 2008
- Last updated
- 22 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Large Diameter Metal-on-Metal Total Hip System IDE
- ClinicalTrials.gov ID
- NCT00867256
- Acronym / sponsor ID
- LDMOM
- Conditions
- Osteoarthritis, Rheumatoid Arthritis, Avascular Necrosis
- Keywords
- arthritis
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: terminated for business reasons; study closed.
- Enrolment
- 195 participants (actual)
- Lead sponsor
- CorinIndustry (pharma, biotech, devices)
- Study start
- 31 Mar 2004 (actual)
- Primary completion
- 23 Oct 2006 (actual)
- Study completion
- 27 Apr 2009 (actual)
- First posted
- 23 Mar 2009 (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.
To demonstrate the safety and efficacy of the Cormet Large Diameter Metal on Metal (LDMOM) Total Hip System using a composite clinical success (CCS) primary endpoint.
Detailed description
The results from the Cormet Large Diameter Metal on Metal (LDMOM) Total Hip System cohort will be compared to the historical results from a ceramic on ceramic (CoC) hip system cohort. The primary endpoint clinical composite success (CCS) criterion at 24 months postoperative is based on a Harris Hip Score ≥ 80 and the absence of any revision,replacement, or modification of any study component.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Large Diameter Metal on Metal | Experimental | Device: Large Diameter Metal on Metal |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- is skeletally mature
- is mentally capable of completing follow-up forms
- will be available for follow-up out to 2 years
- has a preoperative Harris Hip Score <70 points
- has been deemed a candidate for hip replacement by diagnosis of the investigator.
Key exclusion criteria (13 listed)
- has active joint infection
- has had previous hip arthrodesis (fusion)
- has had above knee amputation of either extremity
- has active neoplastic disease
- has a need for a structural bone graft in the operative side
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 |
|---|---|---|
| Large Diameter Metal on Metal | Device | Large Diameter Metal on Metal |
Primary outcome
Composite clinical criterion
Time frame: 24-months postoperative
Based on Harris Hip Score ≥ 80, and absence of any revision, replacement, or modification of any study component
Results and safety
The study was stopped early (reason given: terminated for business reasons; study closed.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2023.
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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.
Giulia Carli study director
Corin Ltd
Questions about this trial
What is this clinical trial studying?
A study testing Large Diameter Metal on Metal in people with Osteoarthritis and Rheumatoid Arthritis, run by Corin.
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 6 inclusion and 13 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 22 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
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: terminated for business reasons; study closed.). 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?
Composite clinical criterion (time frame: 24-months postoperative). 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 22 Sep 2023.