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Trial registered on ANZCTR


Registration number
ACTRN12610000192088
Ethics application status
Approved
Date submitted
1/03/2010
Date registered
3/03/2010
Date last updated
9/07/2019
Date data sharing statement initially provided
9/07/2019
Date results information initially provided
9/07/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
A study of patient-specific cutting guides for total knee joint replacement.
Scientific title
In patients with osteoarthritis of the knee, are patient specific cutting guides used for total knee joint replacement as good as traditional instruments for patient outcomes?
Secondary ID [1] 1453 0
None
Universal Trial Number (UTN)
U1111-1113-8182
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Osteoarthritis of the knee 256888 0
Condition category
Condition code
Musculoskeletal 257036 257036 0 0
Osteoarthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patient-specific cutting guides will be manufactured based on pre-operative Magnetic Resonance Imaging (MRI) scans. Total knee arthroplasty will be peformed using computer-assisted surgery. The approximate duration of the procedure is 90-120 minutes. Participants will undergo either intra-operative assessment of cutting guide precision (Group A) or use of the cutting guides to perform bony resection of the distal femur and proximal tibia (Group B). Total knee replacement components will be implanted. Participants whre the cutting guides were used in surgery will undergo post-operative Computed Tomography (CT) scans.
Intervention code [1] 256083 0
Treatment: Devices
Comparator / control treatment
Group A - Published results of studies of precision of instrumentation in total knee joint replacement from all available years.
Group B - Historical controls of patients undergoing total knee joint replacement at study sites (dates vary by surgeon and site), published literature and other related sponsored studies for Triathlon Primary Total Knee System since 2005. Published and unpublished data using Perth CT protocol for assessment of total knee replacement outcomes since 2004.
Control group
Historical

Outcomes
Primary outcome [1] 257926 0
Precision of cutting guide position on the distal femur and proximal tibia assessed by repeated measures using computer navigation system for total knee replacement.
Timepoint [1] 257926 0
Intra-operatively.
Primary outcome [2] 257927 0
Radiographic implant location, consisting of multiparameter assessment of the relative position and orientation of the femoral and tibial components and overall limb alignment, assessed by the Perth CT protocol.
Timepoint [2] 257927 0
3 months post-op.
Secondary outcome [1] 263412 0
Knee function before and after surgery using International Knee Society Score (IKS) and Knee injury and Osteoarthritis Outcome Score (KOOS).
Timepoint [1] 263412 0
Pre-op, 6 weeks post-op, 3 months post-op, 6 months post-op.
Secondary outcome [2] 263463 0
Quality of life before and after surgery assessed by Short Form (SF)-12.
Timepoint [2] 263463 0
Pre-op, 6 weeks post-op, 3 months post-op, 6 months post-op.
Secondary outcome [3] 263464 0
Pain assessed by Visual Analogue Scale (VAS).
Timepoint [3] 263464 0
Pre-op, 6 weeks post-op, 3 months post-op, 6 months post-op.

Eligibility
Key inclusion criteria
1. The patient is a male or non-pregnant female between the ages of 50-90.
2. The patient requires a primary total knee replacement and is indicated for computer-assisted surgery.
3. The patient has a primary diagnosis of osteoarthritis (OA).
4. The patient has intact collateral ligaments.
5. The patient is able to undergo MRI scanning of the affected limb.
6. The patient has signed the study specific, Human Research Ethics Committee (HREC) approved, Informed Consent document.
7. The patient is willing and able to comply with the specified pre-operative and post-operative clinical and radiographic evaluations.
Minimum age
50 Years
Maximum age
90 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. The patient has a history of total, unicompartmental reconstruction or fusion of the affected joint.
2. Patient has had a high tibial osteotomy or femoral osteotomy.
3. The patient is morbidly obese (Body Mass Index, BMI = 40).
4. The patient has a deformity which will require the use of stems, wedges or augments in conjunction with the Triathlon Total Knee System.
5. The patient has a varus/valgus malalignment = 15 degrees.
6. The patient has a fixed flexion deformity = 15 degrees.
7. The patient has a neuromuscular or neurosensory deficiency, which would limit the ability to assess the performance of the device.
8. The patient has a systemic or metabolic disorder leading to progressive bone deterioration.
9. The patient is immunologically suppressed or receiving steroids in excess of normal physiological requirements.
10. Patient has a cognitive impairment, an intellectual disability or a mental illness.
11. The patient is pregnant.
12. The patient has no metal hardware present in the region of the hip, knee or ankle
13. The patient has any known contraindications for undergoing assessment by MRI

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)
Participants will be assigned to Group A in a sequential manner until the target number of subjects has been reached. Subsequent participants will be assigned to Group B.
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
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
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)
NSW,QLD,WA
Recruitment postcode(s) [1] 2600 0
3000
Recruitment postcode(s) [2] 2601 0
8000
Recruitment postcode(s) [3] 2602 0
2000

Funding & Sponsors
Funding source category [1] 256578 0
Commercial sector/Industry
Name [1] 256578 0
Stryker Australia
Address [1] 256578 0
8 Herbert Street,
ST LEONARDS, NSW 2065
Country [1] 256578 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Stryker Australia
Address
8 Herbert Street,
ST LEONARDS, NSW 2065
Country
Australia
Secondary sponsor category [1] 255872 0
None
Name [1] 255872 0
Address [1] 255872 0
Country [1] 255872 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258612 0
Southern Health HREC
Ethics committee address [1] 258612 0
Research Directorate
Level 4, Main Block
246 Clayton Rd
CLAYTON Vic 3168
Ethics committee country [1] 258612 0
Australia
Date submitted for ethics approval [1] 258612 0
03/03/2010
Approval date [1] 258612 0
28/09/2010
Ethics approval number [1] 258612 0
EC00383
Ethics committee name [2] 266904 0
Bellberry Ltd
Ethics committee address [2] 266904 0
229 Dulwich Road, DULWICH SA 5065
Ethics committee country [2] 266904 0
Australia
Date submitted for ethics approval [2] 266904 0
Approval date [2] 266904 0
04/11/2011
Ethics approval number [2] 266904 0
2010-08-244
Ethics committee name [3] 266905 0
Mater Health Services NQ Ltd
Ethics committee address [3] 266905 0
Locked Bag 1000, AITKENVALE BC QLD 5814
Ethics committee country [3] 266905 0
Australia
Date submitted for ethics approval [3] 266905 0
Approval date [3] 266905 0
23/07/2010
Ethics approval number [3] 266905 0
New ethics HREC. Please modify.
Ethics committee name [4] 266906 0
Royal Perth Hospital Ethics Committee
Ethics committee address [4] 266906 0
GPO Box X2213 PERTH WA 6847
Ethics committee country [4] 266906 0
Australia
Date submitted for ethics approval [4] 266906 0
Approval date [4] 266906 0
17/06/2010
Ethics approval number [4] 266906 0
EC 2010/030

Summary
Brief summary
Total knee joint replacement is a successful operation for the relief of symptoms such as pain, loss of function and inability to perform daily activities. New techniques are constantly being developed to improve these results even further.

This study aims to see how well a very new technique for total knee joint replacement surgery performs in a small number of patients. The technique involves patients having a MRI scan before their operation. This scan enables very detailed 3-D pictures of the bones, cartilage and soft-tissues around the hip, knee and ankle to be obtained. This information is then used to reconstruct a 3-D model of the pre-disease anatomy for that particular patient. This model is used to create two plastic blocks which will be used by the surgeon to perform a total knee joint replacement.

Specific questions about how precise the cutting guides can be positioned onto the bone (that is, if the guides are positioned several times, how much does the position vary?) and are there advantages in the recovery and function of patients in the period after their operation will be addressed by this study. The results of this study will be compared to the results obtained using similar total joint replacement components.

Patients will be asked to complete surveys to assess their pain, quality of life and knee function before and after their operation.

It is hoped that the information collected during this multi-centre study will provide valuable information regarding the use of patient-specific cutting guides for total knee joint replacement.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 30882 0
Dr Gavin Clark
Address 30882 0
Royal Perth Hospital Shenton Park Campus
6 Selby Street
Shenton Park, WA 6008
Country 30882 0
Australia
Phone 30882 0
+61 8 9389 3800
Fax 30882 0
Email 30882 0
gavin@hollywoodorthopaedics.com.au
Contact person for public queries
Name 14129 0
Mr David Fulker
Address 14129 0
Stryker
8 Herbert Street
St Leonards, 2065
NSW
Country 14129 0
Australia
Phone 14129 0
+61 2 9467 1072
Fax 14129 0
Email 14129 0
david.fulker@stryker.com
Contact person for scientific queries
Name 5057 0
Mr David Fulker
Address 5057 0
Stryker
8 Herbert Street
St Leonards, 2065
NSW
Country 5057 0
Australia
Phone 5057 0
+61 2 9467 1072
Fax 5057 0
Email 5057 0
david.fulker@stryker.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
What supporting documents are/will be available?
No other documents available
Summary results
Have study results been published in a peer-reviewed journal?
No
Other publications
Have study results been made publicly available in another format?
No
Results – basic reporting
Results – plain English summary