Knee ArthroplastyNCT00759616
Outcome Analysis of the Oxford Partial Knee Arthroplasty
A study testing Oxford Partial Knee in people with Knee Arthroplasty, run by Zimmer Biomet at 1 site in Canada.
Trial summary
Prospectively monitor the patients receiving the Oxford Partial knee arthroplasty Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Knee Arthroplasty
- What is being tested?
- Oxford Partial Knee
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 156 participants
- Where
- 1 siteCanada
- Study dates
- Apr 2003to Jun 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patient Suitable for Knee Replacement
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Prospectively monitor the patients receiving the Oxford Partial knee arthroplasty
Read the detailed description
Utilization of systematic outcome measurements and specific designated time frames to monitor patient satisfactions will assist in analysing this type of prosthesis and the post operative period. Data collected will be added to the compiled information from previous studies in relation to the Oxford knee.
- Conditions
- Knee Arthroplasty
- Being tested
- 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.
Oxford Partial KneeDevice
Oxford Partial Knee
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Device: Oxford Partial Knee |
What is being measured
The primary outcome is the main question the study is designed to answer.
WOMAC, SF12, oxford Knee,KSCRS
Measured: 3weeks, 3months,6months, yearly
Secondary outcomes (1)
Length of Hospital Stay
Measured: Postop
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2008 (estimated)
- Study startApr 2003
- Primary completionJun 2009
- Study completionJun 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee ArthroplastyStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 156 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zimmer Biomet
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Dartmouth General Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00759616
- Sponsor's protocol ID
- BMET CA 03
- Status last verified
- Jun 2017
- First submitted
- 24 Sep 2008
- Last updated
- 16 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcome Analysis of the Oxford Partial Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT00759616
- Acronym / sponsor ID
- BMET CA 03
- Conditions
- Knee Arthroplasty
- Keywords
- Knee Replacement
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 156 participants (actual)
- Lead sponsor
- Zimmer BiometIndustry (pharma, biotech, devices)
- Collaborators
- Dartmouth General Hospital
- Study start
- Apr 2003
- Primary completion
- Jun 2009 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 25 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.
Prospectively monitor the patients receiving the Oxford Partial knee arthroplasty
Detailed description
Utilization of systematic outcome measurements and specific designated time frames to monitor patient satisfactions will assist in analysing this type of prosthesis and the post operative period. Data collected will be added to the compiled information from previous studies in relation to the Oxford knee.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Device: Oxford Partial Knee |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patient Suitable for Knee Replacement
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Oxford Partial KneeOxford Partial Knee | Device | 1 |
Primary outcome
WOMAC, SF12, oxford Knee,KSCRS
Time frame: 3weeks, 3months,6months, yearly
1 secondary outcome
Length of Hospital Stay
Time frame: Postop
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2017.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oxford Partial Knee in people with Knee Arthroplasty, run by Zimmer Biomet at 1 site in Canada.
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 1 inclusion and 0 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: finished, as of the sponsor's last update on 16 Jun 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 Canada. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
WOMAC, SF12, oxford Knee,KSCRS (time frame: 3weeks, 3months,6months, yearly). 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 16 Jun 2017.