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Trial registered on ANZCTR


Registration number
ACTRN12621001243808p
Ethics application status
Submitted, not yet approved
Date submitted
20/07/2021
Date registered
15/09/2021
Date last updated
15/09/2021
Date data sharing statement initially provided
15/09/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Shapematch study (Kinematic vs Mechanical Alignment Total Knee Replacement): A 10 year follow up study
Scientific title
A 10 year follow-up, longitudinal study of the clinical and radiographic outcomes of ShapeMatchNZRCT-10 participants who received a Stryker Triathlon® Custom Fit Knee® using either Stryker PrecisioN Knee Navigation or OtisMed® ShapeMatch® Technology
Secondary ID [1] 304827 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record
This 10 year follow up study is linked to a parent study- ShapeMatchNZRCT-10 (ACTRN12611000147987).

Health condition
Health condition(s) or problem(s) studied:
Osteoarthritis of the knee 322905 0
Condition category
Condition code
Musculoskeletal 320483 320483 0 0
Osteoarthritis
Surgery 320484 320484 0 0
Surgical techniques

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
For patients requiring a total knee replacement a method was developed in hope of improving patient satisfaction levels in terms of function and pain after surgery. Instead of using conventional measuring and cutting equipment and computer-assisted navigation (Control Group), patient-specific cutting guides were manufactured based on pre-operative Magnetic Resonance Imaging (MRI) scans of the patient's leg (Intervention Group). Patients from ShapeMatchNZRCT-10 had a total knee replacement 10 years ago. These replacements were performed using the cutting guides which aligned the patient’s prosthesis according to their natural leg alignment (as opposed to the convention way where the patient’s leg was aligned according to a mechanical axis of 0 degrees). For this study, patients that were involved in ShapeMatchNZRCT-10 will be asked to attend a 10 year follow up out-patient clinic visit. At this 2-3 h single visit, participants will complete assessments relating to quality of life, pain and functional outcome. In addition, participants will have standard knee X-rays taken for radiographic evaluations.
Intervention code [1] 321202 0
Not applicable
Comparator / control treatment
Patients in the Control Group received a total knee replacement using conventional methods and equipment where their implants were positioned so that their leg was a straight line from their hip to their ankle (i.e. mechanical axis of 0 degrees). Both the control and intervention group will be follow up at this 10 year visit. At this 2-3 h single outpatient visit, participants will complete assessments relating to quality of life, pain and functional outcome. In addition, participants will have standard knee X-rays taken for radiographic evaluations.
Control group
Active

Outcomes
Primary outcome [1] 328310 0
To demonstrate, through calculation of Oxford Knee Score at 10 years postoperative, that total knee replacement (TKR) performed using the ShapeMatch Cutting Guide provides improvement of patient pain and function comparable to the improvement obtained with TKR performed using computer-assisted Navigation.
Timepoint [1] 328310 0
10 year post-operatively.
Secondary outcome [1] 398537 0
To compare the difference in radiolucent lines between the ShapeMatch Cutting Guide group and the computer-assisted Navigation control group. This objective will be achieved by utilizing the following instruments:

- Anteroposterior (AP) and mediolateral (ML) X-rays
Timepoint [1] 398537 0
10 year post-operatively
Secondary outcome [2] 398538 0
To demonstrate if there is a difference in the long-term (10 year) survivorship of the prosthesis between the two techniques. This objective will be achieved by going through patients' medical records for any implant revision or re-operation of the study knee and analysing the AP and ML x-rays to assess implant stability.
Timepoint [2] 398538 0
10 year post-operatively
Secondary outcome [3] 399465 0
To compare the functional outcome of the knee between the two techniques, This objective will be achieved by utilizing the following instruments:

- The International Knee Society Score (IKSS)


Timepoint [3] 399465 0
10 year post-operatively
Secondary outcome [4] 399470 0
To compare the functional outcome of the knee between the two techniques, This objective will be achieved by utilizing the following instruments:

- The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Timepoint [4] 399470 0
10 year post-operatively
Secondary outcome [5] 399473 0
To compare the restoration of "normal feeling" of the knee after surgery between the two techniques, This objective will be achieved by utilizing the following instruments:

- The forgotten joint score (FJS)
Timepoint [5] 399473 0
10 year post-operatively
Secondary outcome [6] 399477 0
To compare the difference in pain between the two techniques, This objective will be achieved by utilizing the following instruments:

- The International Knee Society Score
Timepoint [6] 399477 0
10 year post-operatively
Secondary outcome [7] 399478 0
To compare the difference in pain between the two techniques, This objective will be achieved by utilizing the following instruments:

- WOMAC
Timepoint [7] 399478 0
10 year post-operatively
Secondary outcome [8] 399479 0
To compare the difference in pain between the two techniques, This objective will be achieved by utilizing the following instruments:

- The visual analog scale (VAS) pain
Timepoint [8] 399479 0
10 year post operatively
Secondary outcome [9] 399481 0
To compare the difference in health-related quality of life between the two techniques, This objective will be achieved by utilizing the following instruments:

- European Quality of Life Five Dimension (EQ-5D)
Timepoint [9] 399481 0
10 year post-operatively
Secondary outcome [10] 399484 0
To determine if there is a difference in the proportion of patients that experienced complications related to the knee between the two techniques. This objective will be achieved by going through patients' medical records to check for any significant medical events related to the operated knee from the end of ShapeMatchNZRCT-10 study period to the signing of the new study consent form for this 10 year follow up visit.
Timepoint [10] 399484 0
10 year post-operatively

Eligibility
Key inclusion criteria
-Patient was enrolled in ShapeMatchNZRCT-10 (ACTRN12611000147987) and completed either the 2 year and 5 year follow-up visit (or both).

-Patient is willing and able to give informed consent to participate in the study.

-Patient is willing and able to comply with the specified 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
-Patient no longer has the Triathlon® Total Knee System in situ, including patients that have had revision surgery.

-Patient has a cognitive impairment, an intellectual disability or a mental illness that is considered by the investigator to inhibit the patient’s capacity to consent to research and the ability to participate in it.

-Patient no longer resides in a geographical location that would reasonably permit clinic visits at protocol specified intervals.

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Sample size calculation was done for the initial ShapeNZRCT-10 study, where oxford knee score (OKS) was used as the primary outcome measure. A minimum of 45 patients per group was required based on an improvement from 37 (mean OKS reported in the New Zealand Joint Registry) to 42 (scoring category of excellent), with 80% power and significance level of 5%. An additional 5 patients per group (10%) has been included into the target patient number to allow for loss to follow-up, bringing the target to 50 patients per group.

To be eligible for this 10 year follow up study, patients must be enrolled in ShapeMatchNZRCT-10 and attended the 2 and 5 year follow up visit. A total of 95 patients attended these follow up visits (47 from the interventional group and 48 form the control group), so for this 10 year follow up, a maximum of 95 patients will be re-enrolled to the study.


Recruitment
Recruitment status
Not yet recruiting
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 outside Australia
Country [1] 23976 0
New Zealand
State/province [1] 23976 0

Funding & Sponsors
Funding source category [1] 309199 0
Charities/Societies/Foundations
Name [1] 309199 0
Orthopaedic Education and Research Fund- Three Harbours Health Foundation
Address [1] 309199 0
Orthopaedic Education and Research Fund
Three Harbours Health Foundation
Private Bag 93-503
Takapuna
Auckland 0622
NZ
Country [1] 309199 0
New Zealand
Funding source category [2] 309200 0
Commercial sector/Industry
Name [2] 309200 0
Stryker
Address [2] 309200 0
8 Herbert St, St Leonards NSW 2065, Australia
Country [2] 309200 0
Australia
Primary sponsor type
Hospital
Name
North Shore Hospital Waitemata DHB
Address
North Shore Hospital
124 Shakespeare Road
Takapuna
Auckland 0622
New Zealand
Country
New Zealand
Secondary sponsor category [1] 310159 0
None
Name [1] 310159 0
Address [1] 310159 0
Country [1] 310159 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 309053 0
Northern B Health and Disability Ethics Committee
Ethics committee address [1] 309053 0
Ministry of Health
Health and Disability Ethics Committees
PO Box 5013
Wellington 6140
Ethics committee country [1] 309053 0
New Zealand
Date submitted for ethics approval [1] 309053 0
14/07/2021
Approval date [1] 309053 0
Ethics approval number [1] 309053 0

Summary
Brief summary
This is a 10 year follow up, longitudinal study of the clinical and radiographical outcomes of patients who participated in ShapeNZRCT-10 in 2011. In ShapeNZRCT-10, participants received a Stryker Triathlon® Total Knee System for Total Knee Arthroplasty (TKA) implanted using either Stryker OtisMed® ShapeMatch® Technology (intervention) or Stryker PrecisioN v4.0 Knee Navigation (control). For the purpose of this extended follow up study, we are looking to answer the following questions: (1)Are 10-year patient-reported outcome scores (PROMS) comparable in patients allocated to the intervention group compared to the control group? (2)Is there a difference in the long-term (10 year)
survivorship of the prosthesis between the techniques? (3)Is there a difference in the
revision/re-operation rate and the proportion of patients that experienced complications between the two techniques? (4)Is there a difference in radiolucent lines between the two techniques?
There will be 2 sites (North Shore Hospital, Auckland and Waitakere Hospital, Waitakere), 1 Principal Investigator and 3 co-Investigators for this study. Approximately 95 patients will participate in the study. Total duration of the study is expected to be 2 year.
The study consists of two groups:
Intervention Group: Treatment by total knee replacement with a target lower limb alignment determined using preoperative imaging and kinematic alignment;
Control Group: Treatment by total knee replacement with a target lower limb alignment equal to neutral Mechanical Axis.

All participants will be requested to attend an outpatient visit as part of the study. At the visit, participants will complete assessments relating to quality of life, pain and functional outcome. In addition, participants will have standard knee X-rays taken. Data will also be captured on the secondary objectives of revision rate.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 112802 0
Mr Simon Young
Address 112802 0
Orthopaedic department
North Shore Hospital
Waitemata DHB
Private Bag 93503
North Shore City 0622
Auckland
Country 112802 0
New Zealand
Phone 112802 0
+64 94 868 900
Fax 112802 0
Email 112802 0
simon.young@auckland.ac.nz
Contact person for public queries
Name 112803 0
Mr Simon Young
Address 112803 0
Orthopaedic department
North Shore Hospital
Waitemata DHB
Private Bag 93503
North Shore City 0622
Auckland
Country 112803 0
New Zealand
Phone 112803 0
+64 94 868 900
Fax 112803 0
Email 112803 0
simon.young@auckland.ac.nz
Contact person for scientific queries
Name 112804 0
Mr Simon Young
Address 112804 0
Orthopaedic department
North Shore Hospital
Waitemata DHB
Private Bag 93503
North Shore City 0622
Auckland
Country 112804 0
New Zealand
Phone 112804 0
+64 94 868 900
Fax 112804 0
Email 112804 0
simon.young@auckland.ac.nz

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
No Results