Trial Review

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12609000626268
Ethics application status
Not yet submitted
Date submitted
20/07/2009
Date registered
28/07/2009
Date last updated
28/07/2009
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluation of Smith and Nephew Visionaire Patient-Matched Instrumentation For Total Knee Arthroplasty Using Computer Navigation
Scientific title
Evaluation of Limb and Component Alignment Following Total Knee Arthroplasty with Smith and Nephew Visionaire Patient-Matched Instrumentation Using Computer Navigation
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Osteoarthritis of the Knee 237302 0
Condition category
Condition code
Surgery 239625 239625 0 0
Surgical techniques
Musculoskeletal 239655 239655 0 0
Osteoarthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Currently knee replacement surgery is performed using external jigs or a computer navigation system to guide bone cuts necessary to implant the metal and plastic prosthesis. The computer navigation system is considered the "gold standard" for guiding and evaluating the cuts. However, new technology as been developed that allows patient-specific instruments to be manufactured based on a pre-operative magnetic resonance imaging [MRI] scan and x-rays of the affected knee. These instruments should allow bone cuts and thus implants to be positioned more accurately. The current study will include 10 patients that have met the criteria for total knee replacement. The patients will require a pre-operative MRI and full-leg x-rays. Their surgery will be performed with the custom instrumentation. All bone cuts will be evaluated intra-operatively, using the computer navigation system. Any cut that is inappropriate will be revised using the standard, computer navigated instruments. The surgery will require approximately 2 hours. The patients will require a post-operative computed tomography [CT] scan and full-leg x-rays to evaluate the limb and implant alignment. These studies will be performed 6 weeks post-operatively. Otherwise, the recovery and post-operative follow-up will be unchanged from that expected for routine knee replacement surgery.
Intervention code [1] 236980 0
Treatment: Surgery
Comparator / control treatment
None
Control group
Uncontrolled

Outcomes
Primary outcome [1] 238412 0
Limb and component alignment as determined using intra-operative computer navigation and post-operative x-rays/computed tomography [CT] scan.
Timepoint [1] 238412 0
Routine post-operative x-rays will be perfomed prior to discharge. The CT scan and full-leg, weight-bearing x-rays will be performed once at 6 weeks post-operatively.
Secondary outcome [1] 244891 0
Nil
Timepoint [1] 244891 0
Nil

Eligibility
Key inclusion criteria
Patients with osteoarthritis of the knee.
Minimum age
50 Years
Maximum age
90 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Medically unfit for elective surgery.
Pregnancy.
Prior arthroplasty or limb alignment surgery.
Infection.
Inflammatory arthritis.

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)
All patients in Dr. Parker's orthopaedic clinic at Royal North Shore Hospital, who meet the inclusion/exclusion criteria will be offered participation in the study.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Non-radomized study.
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
Not yet recruiting
Date of first participant enrolment
Anticipated
1/09/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
10
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 237363 0
Charities/Societies/Foundations
Name [1] 237363 0
Sydney Orthopaedic Research Institute
Country [1] 237363 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
Sydney Orthopaedic Research Institute
Address
Level 1 The Gallery Arcade
445 Victoria Ave
Chatswood NSW 2067
Country
Australia
Secondary sponsor category [1] 236858 0
None
Name [1] 236858 0
Address [1] 236858 0
Country [1] 236858 0
Other collaborator category [1] 779 0
Commercial sector/Industry
Name [1] 779 0
Smith and Nephew Surgical Pty Ltd.
Address [1] 779 0
19-25 Khartoum Road
North Ryde NSW 2113
Country [1] 779 0
Australia

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 239491 0
Northern Sydney Health Human Research Ethics Committee (Harbour)
Ethics committee address [1] 239491 0
Research Office
Level 2, Building 51,
Royal North Shore Hospital
ST. LEONARDS NSW 2065
Ethics committee country [1] 239491 0
Australia
Date submitted for ethics approval [1] 239491 0
01/08/2009
Approval date [1] 239491 0
Ethics approval number [1] 239491 0
EC00333

Summary
Brief summary
Currently knee replacement surgery is performed using external jigs or a computer navigation system to guide bone cuts necessary to implant the metal and plastic prosthesis. The computer navigation system is considered the "gold standard" for guiding and evaluating the cuts. However, new technology as been developed that allows patient-specific instruments to be manufactured based on a pre-operative MRI scan and x-rays of the affected knee. These instruments should allow bone cuts and thus implants to be positioned more accurately. The current study will include 10 patients that have met the criteria for total knee replacement. The patients will require a pre-operative MRI and full-leg x-rays. Their surgery will be performed with the custom instrumentation. All bone cuts will be evaluated intra-operatively, using the computer navigation system. Any cut that is inappropriate will be revised using the standard, computer navigated instruments. The surgery will require approximately 2 hours. The patients will require a post-operative computer tomography [CT] scan and full-leg x-rays to evaluate the limb and implant alignment. These studies will be performed 6 weeks post-operatively. Otherwise, the recovery and post-operative follow-up will be unchanged from that expected for routine knee replacement surgery. Our hypothesis is that the patient-matched instrumentation will align the bone cuts, implants, and the mechanical axis of the limb at least as well as would be expected using external jigs or computer assisted surgery.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29932 0
Address 29932 0
Country 29932 0
Phone 29932 0
Fax 29932 0
Email 29932 0
Contact person for public queries
Name 13179 0
Curtis Hanson
Address 13179 0
Level 1 The Gallery Arcade
445 Victoria Ave
Chatswood NSW 2067
Country 13179 0
Australia
Phone 13179 0
+61 2 9904 7182
Fax 13179 0
+61 2 9410 0666
Email 13179 0
[email protected]
Contact person for scientific queries
Name 4107 0
Curtis Hanson
Address 4107 0
Level 1 The Gallery Arcade
445 Victoria Ave
Chatswood NSW 2067
Country 4107 0
Australia
Phone 4107 0
+61 2 9904 7182
Fax 4107 0
+61 2 9410 0666
Email 4107 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
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.