ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12610000923066

Ethics application status

Approved

Date submitted

28/10/2010

Date registered

29/10/2010

Date last updated

29/10/2010

Type of registration

Retrospectively registered

Titles & IDs

Public title

The Visionaire Cutting Block System - An Outcome Study

Scientific title

Evaluation of Limb and Component Alignment, Cost and Surgical Time Compared to Conventional Total Knee Arthroplasty Methods Following Total Knee Arthroplasty with Smith and Nephew Visionaire Patient-Matched Instrumentation

Secondary ID [1]

2010023 - Ethics of Human Research Committee

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Osteoarthritis of the Knee

Condition category

Condition code

Surgery

Surgical techniques

Musculoskeletal

Osteoporosis

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 most accurate for guiding and evaluating the cuts but it has been shown to increase surgery time. Many surgeons still prefer the conventional external jigs calculating alignment with an intra medullary rod for the femoral component and an external rod to align the tibial component. These surgeons feel the time saved by using the conventional methods outweigh the small increase in alignment accuracy achieved by the navigation technique. There is however new technology 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 than conventional intra-medullary rod method in addition to decrease overall surgical time. Additional factors are that much less equipment is needed when using the patient-specific instruments as the prosthesis size is known pre-operatively. This has the potential to cut cost significantly. The current study will include 50 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 a micrometer to measure actual bone resection thickness compared to that which is predicted by the MRI data. Any cut that is inappropriate will be revised using the standard conventional alignment method. It will be within the surgeons capacity and at the surgeons discretion whether they over-ride the patient specific jigs and continue with the surgery using conventional techniques for alignment. The surgery time will vary but expected average times will be 80 minutes. The patients will require a post-operative computed tomography [CT] scan to evaluate the limb and implant alignment. This scan will be performed at least 6 weeks post-operatively. The recovery and post-operative follow-up will be unchanged from that expected for routine knee replacement surgery. The participants will also be assessed for range of movement, Knee Society Score, General Health Questionnaire and the Oxford Knee Score pre-operatively, and at three, six and twelve months post operatively.

Intervention code [1]

Treatment: Surgery

Comparator / control treatment

None

Control group

Uncontrolled

Outcomes

Primary outcome [1]

Limb and component alignment as determined post-operative computed tomography [CT] scan

Timepoint [1]

Six weeks post-operatively

Primary outcome [2]

Comparative cost between Patient Matched Instrumentation method and Conventional Rod Alignment method

Timepoint [2]

Post-operatively

Secondary outcome [1]

Comparative surgical time between Patient Matched Instrumentation method and Conventional Rod Alignment method.

Timepoint [1]

Imediately post-surgery

Secondary outcome [2]

Patients subjective mobility level, ability for self care, pain level, depression/anxiety level, activities of daily living level and knee stability level assessed by General Health Questionnaire, Knee Society Questionnaire and Oxford Knee Questionnaire. Also objective measurements of Knee Flexion, Extention, stability, varus/valgus angle and extension lag assessed by goniometer and recorded in Knee Society Questionnaire.

Timepoint [2]

Pre-operatively and at three months, six months and twelve months post-operatively

Secondary outcome [3]

Difference between actual bone resection thickness and MRI based predicted resection thickness

Timepoint [3]

Intra-operatively

Eligibility

Key inclusion criteria

Patients with osteoarthritis of the knee

Minimum age

20 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Yes

Key exclusion criteria

Medically unfit for elective surgery.
Pregnancy.
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 on the surgical waiting list for participating Orthopaedic surgeons at The Queen Elizabeth Hospital, that are not involved in other orthopaedic trials and 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)

Nonrandomised trial

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

Recruiting

Date of first participant enrolment

Anticipated

30/04/2010

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)

Funding & Sponsors

Funding source category [1]

Commercial sector/Industry

Name [1]

Smith and Nephew Surgical Pty Ltd.

Address [1]

19-25 Khartoum Road
North Ryde NSW 2113

Country [1]

Australia

Primary sponsor type

Hospital

Name

The Queen Elizabeth Hospital Deptartment of Orthopaedics and trauma

Address

28 Woodville Road
Woodville South
SA 5011

Country

Australia

Secondary sponsor category [1]

Individual

Name [1]

Mr Gordon Morrison

Address [1]

28 Woodville Road
Woodville South
SA 5011

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Central Northern Adelaide health Service Ethics of Human Research Committee (TQEH & LMH)

Ethics committee address [1]

28 Woodville Road
Woodville South
SA 5011

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

19/03/2010

Approval date [1]

27/04/2010

Ethics approval number [1]

2010023

Summary

Brief summary

Currently knee replacement surgery is performed using alignment rods that correctly position the cutting blocks which guide bone cuts necessary to implant the metal and plastic total knee joint. Using a computer navigation system during surgery is considered the "gold standard" for guiding the cuts. Many surgeons however find this extends the time of the surgery for what is considered only a marginally better aligned knee and for much of the time the alignment is the same. These surgeons feel that the accuracy of the alignment of the total knee replacement without computer navigation is very good anyway and it is quicker to do. There is however new technology that has been developed that allows patient-specific cutting blocks, which are said to guide the cuts more accurately, to be manufactured based on a an MRI scan and x-ray of the affected knee taken before surgery. In this way it may be possible to have the accuracy of computer navigation in addtion to decreasing surgical time. This would be potentially good for the patients for a number of reasons including shorter operation time resulting in less chance of complications. In addition to this, less instuments will need to be used during surgery because the surgeon will already know the size of the knee replacement needed. This will reduce the cost of surgery while potentially increasing the accuracy. The current study will include 50 patients that have met the criteria for total knee replacement on the waiting list. 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 measured during surgery and compared to the bone cuts the MRI scan predicted. The surgeon can override the custom made blocks at any time and continue surgery in the conventional way if they feel the blocks are in any way inaccurate. The surgery time will vary but on average it should require approximately 80 minutes. The patients will require a post-operative computer tomography [CT] scan to evaluate the limb and implant alignment and information will be collected including pain levels, how far a person can walk and the affected knee's range of motion. This scan will be performed at least 6 weeks after surgery and the other information will be gathered before surgery and also at 3,6 and 12 months after surgery. 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 the conventional alignment rods, will cost less and on average speed up the surgery.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Address

Country

Phone

Fax

Contact person for public queries

Name

Mr Graeme West

Address

28 Woodville Road
Woodville South
SA 5011

Country

Australia

Phone

+61 8 82228639

Fax

Graeme.West@health.sa.gov.au

Contact person for scientific queries

Name

Mr Graeme West

Address

28 Woodville Road
Woodville South
SA 5011

Country

Australia

Phone

+61 8 82228639

Fax

Graeme.West@health.sa.gov.au

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.

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