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Trial registered on ANZCTR


Registration number
ACTRN12609000514202
Ethics application status
Approved
Date submitted
19/06/2009
Date registered
29/06/2009
Date last updated
6/07/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
Prospective clinical study using X-ray to evaluate fixation of cementless total knee replacement components
Scientific title
In patients with osteoarthritis of the knee, do cementless total knee replacement components, comparing radiographic micromotion at 6 months and 2 years, provide adequate long-term fixation at the implant-bone interface.
Secondary ID [1] 280292 0
Nil
Universal Trial Number (UTN)
U1111-1129-8733
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Osteoarthritis of the knee 237068 0
Condition category
Condition code
Musculoskeletal 237389 237389 0 0
Osteoarthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Total knee arthroplasty will be performed using a traditional medial parapatellar approach. Distal femur and proximal tibia resections will be completed using intramedullary alignments jigs. Implantation of the femoral and tibial tray components will be performed without the use of bone cement. The approximate duration of the procedure is 90-120 minutes. Micromotion of the implanted components will be assessed by X-ray, using the pre-weight-bearing position as the base for subsequent measurements.
Intervention code [1] 236784 0
Treatment: Devices
Comparator / control treatment
Not a controlled study.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 238188 0
Radiographic micromotion, consisting of component migration and rotation relative to the proximal tibia and distal femur.
Timepoint [1] 238188 0
Post-op before weight-bearing; 6 weeks post-op; 3 months post-op; 6 months post-op; 1 year post-op; 2 years post-op
Secondary outcome [1] 242494 0
Knee function assessed before and after surgery using International Knee Society Score (IKSS), SF-36, Western Ontario and McMaster Universities Questionnaire(WOMAC), Oxford Knee Score, Self-Administrered Comorbidity Questionnaire, Patient Catastrophising Scale, University of California Los Angeles (UCLA) Activity Level Scale.
Timepoint [1] 242494 0
Pre-op, 6 weeks post-op; 3 months post-op; 6 months post-op; 1 year post-op; 2 years post-op
Secondary outcome [2] 242495 0
Knee function using Walkabout Portable Gait Monitor.
Timepoint [2] 242495 0
Pre-op, 12 months post-op

Eligibility
Key inclusion criteria
1. Symptomatic osteoarthritis of the knee requiring intervention.
2. Between the ages of 21 and 80 years inclusive.
3. Ability to give informed consent.
Minimum age
21 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Significant co-morbidity affecting ability to ambulate
2. Flexion contracture greater than 15 degrees
3. Extension lag greater than 10 degrees
4. Tibial subluxation greater than 10mm on standing radiograph
5. Prior arthroplasty, patellectomy or osteotomy with the affected knee
6. Lateral or medial collateral ligament instability (>10 degrees varus/valgus)
7. Leg length discrepancy greater than 10mm
8. Active or prior infection
9. Morbid obesity (Body Mass Index, BMI > 40)
10. Medical condition precluding major surgery
11. Severe osteoporosis or osteopenia
12 Neuromuscular impairment

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Not applicable.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Not applicable.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
6/07/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 237182 0
Commercial sector/Industry
Name [1] 237182 0
Stryker Orthopaedics
Country [1] 237182 0
United States of America
Primary sponsor type
Commercial sector/Industry
Name
Stryker Australia
Address
8 Herbert Street
St Leonards
NSW 2065
Country
Australia
Secondary sponsor category [1] 4675 0
None
Name [1] 4675 0
Address [1] 4675 0
Country [1] 4675 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 239275 0
St John of God Health Care Ethics Committee
Ethics committee address [1] 239275 0
Level 3 St John of God House
117-179 Cambridge Street
Subiaco WA 6008
Ethics committee country [1] 239275 0
Australia
Date submitted for ethics approval [1] 239275 0
Approval date [1] 239275 0
26/10/2007
Ethics approval number [1] 239275 0
No. 293

Summary
Brief summary
This study assesses the clinical performance of implants used to treat osteoarthritis using total knee replacement. Highly-accurate X-rays will be used to measure any small motions of the implant components at regular intervals after the knee replacement operation. The health status of patients and ability for them to perform activities of daily living will also be measured. This information will be used to confirm that new methods of securing the knee replacement components to the bone are clinically effective.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29775 0
Address 29775 0
Country 29775 0
Phone 29775 0
Fax 29775 0
Email 29775 0
Contact person for public queries
Name 13022 0
Dr Timothy Barker
Address 13022 0
Director of Clinical Research
Stryker Australia
8 Herbert Street
St Leonards NSW 2065
Country 13022 0
Australia
Phone 13022 0
+61 7 3840 5200
Fax 13022 0
+61 7 3844 8688
Email 13022 0
[email protected]
Contact person for scientific queries
Name 3950 0
Dr Timothy Barker
Address 3950 0
Director of Clinical Research
Stryker Australia
8 Herbert Street
St Leonards NSW 2065
Country 3950 0
Australia
Phone 3950 0
+61 7 3840 5254
Fax 3950 0
+61 7 3844 8688
Email 3950 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
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