Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617000767303
Ethics application status
Approved
Date submitted
19/05/2017
Date registered
24/05/2017
Date last updated
14/08/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Prospective Randomised Controlled Trial Comparing the, Early Clinical
Outcome, and Accuracy of Mechanical Alignment after Computer Navigated
Total Knee Replacement Utilizing the Tibial cut first versus Femoral cut first.
Scientific title
Prospective Randomised Controlled Trial Comparing the, Early Clinical
Outcome, and Accuracy of Mechanical Alignment after Computer Navigated
Total Knee Replacement Utilizing the Tibial cut first versus Femoral cut first.
Secondary ID [1] 289887 0
'Nil Known'
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Total Knee Arthroplasty 299832 0
Osteoarthritis 299834 0
Condition category
Condition code
Musculoskeletal 299751 299751 0 0
Osteoarthritis
Surgery 299754 299754 0 0
Surgical techniques

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Tibial First:
Patients will undergo primary total knee arthroplasty using the Apex Knee system and the Praxim navigation system from Global Orthopaedic Technology. The first cut is performed on the tibial site and the following femoral cuts are determined according to the mediolateral soft tissue tension.

The Praxim 'Registered Trademark' OmniNav 'Trademark' Navigation system is a complete computer surgical navigation
system for use with the APEX Knee. The iBlock 'Registered Trademark' is an intelligent instrument allowing intraoperative customisation in total knee arthroplasty using real-time virtual planning technology followed by automated placement of the cutting guide.

The Apex Knee reconstruction system has been designed to precisely match the size of the tibial insert to the femoral component. The Apex 'Trademark' Knee System offers both porous coated uncemented and cemented versions of its tibial and femoral components.
The Apex Knee reconstruction system is a commercially available, TGA ( Therapeutic Goods Administration) listed device.

The BTS G-walk is a wireless sensor that is placed around the waist with
an ergonomic belt to analyse the walking pattern.
BTS G-Walk 'Registered Trademark' enables functional analysis with objective, accurate and quantitative data. BTS G-WALK 'Registered Trademark' analyzes the walking pattern applying a suite of specific protocols, validated through clinical studies.

.X-Rays will be assessed pre-operatively, post-operatively, at 12 months and 2 years to
evaluate femoral and tibial components orientation and inclination.
Intervention code [1] 295561 0
Treatment: Surgery
Intervention code [2] 298142 0
Treatment: Devices
Comparator / control treatment
Femoral first:

Patients will undergo primary total knee arthroplasty using the Apex Knee system and the Praxim navigation system from Global Orthopaedic Technology. All femoral cuts (distal, anterior, posterior, both chamfer) done first using navigation system followed by tibial cut.
Control group
Active

Outcomes
Primary outcome [1] 299210 0
Range of motion
Measured in the clinic using standard goniometer .
Timepoint [1] 299210 0
Pre-operative, 3 months, 12 months and 2 years post operative.
Secondary outcome [1] 326512 0
Mechanical axis assessed by Radiographic Analysis
Timepoint [1] 326512 0
Pre-operative, Post-op/discharge, 3 months, 12 months and 2 years post operative.
Secondary outcome [2] 335144 0
Joint height measured by radiographic analysis
Timepoint [2] 335144 0
Pre-operative, Post-op/discharge, 3 months, 12 months and 2 years post operative.
Secondary outcome [3] 335208 0
Walking duration, assessed by 10 metre walk test
Timepoint [3] 335208 0
Pre-operative, 3 months, 12 months and 2 years post operative
Secondary outcome [4] 335227 0
Gait length measured using the G-walk device
Timepoint [4] 335227 0
Pre-operative, 3 months, 12 months and 2 years post operative
Secondary outcome [5] 335228 0
Sit to stand movement measured using the G-walk device
Timepoint [5] 335228 0
Pre-operative, 3 months, 12 months and 2 years post operative
Secondary outcome [6] 335230 0
Quality of life assessed by SF36
Timepoint [6] 335230 0
Pre-operative, 3 months, 12 months and 2 years post operative

Eligibility
Key inclusion criteria
1. Patient has diagnosis of Osteoarthritis of the knee eligible for total knee replacement based on history, physical examination and radiological evaluation.
2. The individual has signed a Participant Informed Consent (PIC), specific to this study,
and approved by the Human Research Ethics Committee (HREC)
3. The individual is over 18 years of age.
4. The individual is physically and mentally willing and able to comply with postoperative
scheduled clinical and radiographic evaluations and rehabilitation.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. The individual has an active infection within the affected knee joint.
2. The individual has a neuromuscular or neurosensory deficiency that limits the ability
to evaluate the safety and effectiveness of the device.
3. The individual is unable to return for follow-up visits as outlined in the protocol.
4. The individual has inflammatory arthritis
5. The individual has had a previous Patellectomy
6. The individual has had a previous proximal tibial or distal femoral osteotomy.
7. The individual has Extra-articular deformity
8. The individual has Neuroarthopathy
9. The individual does not speak, read or comprehend the English language.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomisation by phone/fax/computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
A literature review of 7 knee studies reporting Range of motion post knee arthroplasty with
Posterior stabilised implants with a total of 425 patients revealed a mean range of motion
of 123 degrees and SD of 12. In the worst case study, the standard deviation was 21.

The null hypothesis: There is no difference in range of motion between the two groups.
The alternative hypothesis there is a difference of 15 degrees or larger in range of motion
between the two groups.

Accept type I error rate of 5%
If we accept Type II error rate of 20% then
Sample Size 11 for each group (total 22 patients)

If SD=21 (worse case scenario from systematic literature review study sample) will need 32
in each group (n=64 total)

If we accept Type II error rate of 10% then
Sample size 14 in each group (28 in total)

If SD=21 (worse case scenario from systematic literature review study sample) will need 42
in each group (n=84 total).

A total of 100 patients will be recruited to allow for potential lost to follow-up and still
maintain sufficient numbers in both study groups.
Data monitoring will be reviewed and entered into a clinical database. Patients missing the measure of the primary end point will be considered missing in the intent to treat analysis; no inputting of missing data will be conducted for any variables. A secondary per protocol analysis of the primary end point involving only those patients satisfying certain important protocol requirements will be made.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/06/2017
Actual
28/06/2017
Date of last participant enrolment
Anticipated
1/06/2019
Actual
Date of last data collection
Anticipated
1/06/2021
Actual
Sample size
Target
100
Accrual to date
28
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 6433 0
Macquarie University Hospital - Macquarie Park
Recruitment hospital [2] 6434 0
Norwest Private Hospital - Bella Vista
Recruitment postcode(s) [1] 13992 0
2109 - Macquarie Park
Recruitment postcode(s) [2] 13993 0
2153 - Bella Vista

Funding & Sponsors
Funding source category [1] 294254 0
Commercial sector/Industry
Name [1] 294254 0
Global Orthopaedic Technology
Country [1] 294254 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Global Orthopaedic Technology
Address
Unit 10, 7 Meridian Place, Bella Vista, NSW 2153
Country
Australia
Secondary sponsor category [1] 293086 0
None
Name [1] 293086 0
None
Address [1] 293086 0
None
Country [1] 293086 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295679 0
Macquarie University Hospital HREC
Ethics committee address [1] 295679 0
Research Office, Research Hub, Building c5c East, Macquarie University, NSW 2109
Ethics committee country [1] 295679 0
Australia
Date submitted for ethics approval [1] 295679 0
11/05/2016
Approval date [1] 295679 0
27/04/2017
Ethics approval number [1] 295679 0
5201600390

Summary
Brief summary
Study design: Prospective, multi-centre, randomised, clinical study. The study will
enrol 100 patients over a 12-month recruitment period between surgeons at up to
three centres.

Objectives: To determine the relationship between Surgical Technique (workflow) and
patient reported outcomes after total knee arthroplasty (TKA) utilising computer
navigation, comparing tibia cut first with ligament balancing technique to measured
femoral cuts technique. To investigate if patient range of motion and component
alignment is affected by the order of workflow. To investigate if the order of surgical
cuts during total knee replacement affects other parameters such as patient
satisfaction. The study will also demonstrate safety, and equivalent clinical outcomes
on pain and function to other published data.

Groups: Apex Total Knee Replacement using Computer Navigation utilising Tibial Cut
First. Apex Total Knee Replacement using Computer Navigation utilising Measured
Femoral Cuts First.
Number of subjects to be enrolled: 100 patients will be enrolled into this study.

Medical Devices: The Apex Knee is intended for use as a primary total knee
replacement device consisting of a femoral, tibial, tibial bearing and optional patellar
component. The BTS G-walk is a wireless sensor that is placed around the waist with
an ergonomic belt to analyse the walking pattern.

Regulatory status: The Apex Knee is CE marked, TGA approved and has a rebate code
on the Prostheses List.

Clinical evaluations: Standard, functional parameters will be assessed preoperatively,
and post-operatively at 6 weeks, 3months, 1 year, 2years. Published early
results at 1 year then mid-term and long term results after 2 and more years

Patient outcome assessments: The Oxford Knee Score and RAND SF36 operatively at
6 weeks, 3months, 1 year and 2 years.

Radiographic evaluations: X-Rays will be assessed pre-operatively, post-operatively, at 12 months and 2 years to evaluate femoral and tibial components orientation and inclination.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 68110 0
A/Prof Munjed Al Muderis
Address 68110 0
Norwest Advanced Orthopaedics,
Norwest Private Hospital - Ground floor Suite 3B,
Norbrik Drive,
Bella Vista, 2153
NSW
Country 68110 0
Australia
Phone 68110 0
+61 2 8882 9011
Fax 68110 0
Email 68110 0
[email protected]
Contact person for public queries
Name 68111 0
Mr Lyndon Crossley
Address 68111 0
Director of Clinical Affairs
Global Orthopaedic Technology
PO Box 7745
Baulkham Hills BC NSW 2153
Country 68111 0
Australia
Phone 68111 0
+61 2 8887 0100
Fax 68111 0
Email 68111 0
[email protected]
Contact person for scientific queries
Name 68112 0
A/Prof Munjed Al Muderis
Address 68112 0
Norwest Advanced Orthopaedics,
Norwest Private Hospital - Ground floor Suite 3B,
Norbrik Drive,
Bella Vista, 2153
NSW
Country 68112 0
Australia
Phone 68112 0
+61 2 8882 9011
Fax 68112 0
Email 68112 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.