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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00760188




Registration number
NCT00760188
Ethics application status
Date submitted
25/09/2008
Date registered
26/09/2008
Date last updated
5/09/2017

Titles & IDs
Public title
Prospective Data Collection on Cementless Oxford Partial Knee
Scientific title
Prospective Clinical Evaluation of the Cementless Oxford Partial Knee
Secondary ID [1] 0 0
BMET AU 01
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Arthroplasty, Replacement, Knee 0 0
Condition category
Condition code

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Treatment: Devices - Cementless Oxford Partial Knee

Treatment: Devices: Cementless Oxford Partial Knee
Cementless Oxford Partial Knee Replacement

Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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.
Timepoint [1] 0 0
1 yr
Secondary outcome [1] 0 0
Radiographic Assessment - x-ray evaluation
Timepoint [1] 0 0
1yr
Secondary outcome [2] 0 0
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.
Timepoint [2] 0 0
1 yr
Secondary outcome [3] 0 0
Short Form 12 - Short Form 12: Multipurpose short form generic general health measure. The questionnaire looks at physical and mental scores for patients.
Timepoint [3] 0 0
1 yr

Eligibility
Key inclusion criteria
1. Patients undergoing primary knee arthroplasty

2. Patients with one of the following primary diagnoses in the medial compartment of the
knee:

- Osteoarthritis,

- Avascular necrosis
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria:

1. Inability to co-operate with and complete the study.

2. Inadequate fixation of cementless components. If either before or after randomization
the surgeon feels that cementless fixation is inadequate, cemented components should
be inserted.

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Withdrawn
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Rami Sorial , FRACS - Penrith
Recruitment postcode(s) [1] 0 0
- Penrith

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Zimmer Biomet
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Prospective data collection on clinical and radiographic outcomes of Cementless oxford
Partial Knee.
Trial website
https://clinicaltrials.gov/show/NCT00760188
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
N Hunt
Address 0 0
Zimmer Biomet
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT00760188