Arthroplasty, Replacement, KneeNCT00760188
Prospective Data Collection on Cementless Oxford Partial Knee
An observational study of Arthroplasty, Replacement, Knee, run by Zimmer Biomet at 1 site in Australia.
Trial summary
Prospective data collection on clinical and radiographic outcomes of Cementless oxford Partial Knee. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arthroplasty, Replacement, Knee
- What is being tested?
- Cementless Oxford Partial Knee
- Type of treatment
- Medical device
- How many people
- 0 participants
- Where
- 1 siteAustralia
- Study dates
- Dec 2011to Dec 2011
- 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 Received Cementless Oxford Partial Knee for Its Indications for Use/Intended Uses - primary diagnoses in the medial compartment of the knee: * Osteoarthritis, * Avascular necrosis
Who may be able to join
- Patients undergoing primary knee arthroplasty
- Patients with one of the following primary diagnoses in the medial compartment of the knee:
- Osteoarthritis,
- Avascular necrosis
Who cannot join
- Inability to co-operate with and complete the study.
- Inadequate fixation of cementless components. If either before or after randomization the surgeon feels that cementless fixation is inadequate, cemented components should be inserted.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Clinical Evaluation of the Cementless Oxford Partial Knee
Prospective data collection on clinical and radiographic outcomes of Cementless oxford Partial Knee.
Read the detailed description
Prospective radiographic and clinical data collection on outcomes of Cementless oxford Partial Knee. Screened radiographs are taken postoperatively and after 12 months. Oxford Knee Scores, SF12 Health Questionnaires and American Knee Society Radiographic Assessment are taken at 12 month follow-up.
- Conditions
- Arthroplasty, Replacement, Knee
- Being tested
- Cementless Oxford Partial Knee
- Keywords
- knee replacement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cementless Oxford Partial KneeDevice
Cementless Oxford Partial Knee Replacement
What is being measured
The primary outcome is the main question the study is designed to answer.
American Knee Society Score
The Knee Score consists of points given for pain, range of motion, and stability in both the coronal and sagittal planes, with deductions for fixed deformity, and extensor lag. The Function Score consists of points given for the ability to walk on level surfaces, and the ability to ascend and descend stairs, with deductions for the use of external supporting devices.
Measured: 1 yr
Secondary outcomes (3)
Radiographic Assessment
x-ray evaluation
Measured: 1yr
Oxford Knee Score
Oxford Knee Score: Assess the impact that knee pain has on an individual's daily life. The survey consists of 12 self reported questions, where a higher score corresponds with a better outcome.
Measured: 1 yr
Short Form 12
Short Form 12: Multipurpose short form generic general health measure. The questionnaire looks at physical and mental scores for patients.
Measured: 1 yr
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2008 (estimated)
- Study startDec 2011
- Primary completionDec 2011
- Study completionDec 2011
Why it stopped: No patients recruited into study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arthroplasty, Replacement, KneeStudies of the same condition, open and under way.
- More trials run by Zimmer BiometThe sponsor's other registered studies.
- 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zimmer Biomet
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- N Hunt, Study director, Zimmer Biomet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00760188
- Sponsor's protocol ID
- BMET AU 01
- Status last verified
- Jul 2017
- First submitted
- 25 Sep 2008
- Last updated
- 5 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: There is no plan to share Individual Patient Data.
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Clinical Evaluation of the Cementless Oxford Partial Knee
- ClinicalTrials.gov ID
- NCT00760188
- Acronym / sponsor ID
- BMET AU 01
- Conditions
- Arthroplasty, Replacement, Knee
- Keywords
- knee replacement
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: No patients recruited into study.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Zimmer BiometIndustry (pharma, biotech, devices)
- Study start
- Dec 2011 (actual)
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 26 Sep 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.
Prospective data collection on clinical and radiographic outcomes of Cementless oxford Partial Knee.
Detailed description
Prospective radiographic and clinical data collection on outcomes of Cementless oxford Partial Knee. Screened radiographs are taken postoperatively and after 12 months. Oxford Knee Scores, SF12 Health Questionnaires and American Knee Society Radiographic Assessment are taken at 12 month follow-up.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients Who Received Cementless Oxford Partial Knee for Its Indications for Use/Intended Uses - primary diagnoses in the medial compartment of the knee: * Osteoarthritis, * Avascular necrosis
Key inclusion criteria (4 listed)
- Patients undergoing primary knee arthroplasty
- Patients with one of the following primary diagnoses in the medial compartment of the knee:
Key exclusion criteria (2 listed)
- Inability to co-operate with and complete the study.
- Inadequate fixation of cementless components. If either before or after randomization the surgeon feels that cementless fixation is inadequate, cemented components should be inserted.
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 |
|---|---|---|
| Cementless Oxford Partial KneeCementless Oxford Partial Knee Replacement | Device | – |
Primary outcome
American Knee Society Score
Time frame: 1 yr
The Knee Score consists of points given for pain, range of motion, and stability in both the coronal and sagittal planes, with deductions for fixed deformity, and extensor lag. The Function Score consists of points given for the ability to walk on level surfaces, and the ability to ascend and descend stairs, with deductions for the use of external supporting devices.
3 secondary outcomes
Radiographic Assessment
Time frame: 1yr
Oxford Knee Score
Time frame: 1 yr
Short Form 12
Time frame: 1 yr
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2017.
- Individual participant dataSharing planned: No. There is no plan to share Individual Patient Data.
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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.
N Hunt study director
Zimmer Biomet
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 Arthroplasty, Replacement, Knee, run by Zimmer Biomet at 1 site in Australia.
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 4 inclusion and 2 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: withdrawn, as of the sponsor's last update on 5 Sep 2017. 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 Australia. 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 withdrawn before enrolling participants, so there are no results.
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?
American Knee Society Score (time frame: 1 yr). 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 5 Sep 2017.