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Trial registered on ANZCTR


Registration number
ACTRN12622001266752
Ethics application status
Approved
Date submitted
13/09/2022
Date registered
26/09/2022
Date last updated
26/09/2022
Date data sharing statement initially provided
26/09/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Multi-centre Study to evaluate the Medacta GMK SpheriKA Total Knee survivorship (efficacy) following primary Total Knee Arthroplasty
Scientific title
Multi-centre Study to evaluate the survivorship of the Medacta GMK SpheriKA Total Knee following primary Total Knee Arthroplasty
Secondary ID [1] 307664 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Degenerative osteoarthritis 327192 0
Total Knee Arthroplasty 327609 0
Condition category
Condition code
Musculoskeletal 324328 324328 0 0
Osteoarthritis
Surgery 324696 324696 0 0
Other surgery

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The GMK® SpheriKA is a total knee replacement (TKR) device developed by Medacta International SA as a product line extension of the GMK® Sphere femoral component (class III CE-marked). GMK® Sphere has been on the market since 2011. The design of the SpheriKA femoral components is optimized for the kinematic alignment technique, with particular focus on those cases when the position of the femoral component may represent a challenge for the patella tracking.The duration of the procedure will take approximately 1-1.5 hours, as per a standard TKR. The aim of the study is to evaluate patient reported outcome measures, clinical outcomes, radiological outcomes, and survivorship of the GMK SpheriKA device up to 10 years post-operative. All observational participant data will be collected into an existing electronic App (Patient Optimized Pathway) as per standard protocol. Several patient reported outcome measures (PROMS) in the form of questionnaires, will be collected and analysed during the pre-operative visit and again at 6 months, 1 year, 2 years, 5 years and 10 years timepoints post-procedure. The questionnaires should take up to 30 minutes for the participants to complete. Adherence to the intervention will be monitored through ongoing reviews by the independent expert data safety monitoring board (DSMB). The reviews will include the assessment of the results and any adverse events from the study.
Intervention code [1] 324410 0
Treatment: Devices
Comparator / control treatment
The survivorship data will be compared to the best performing medial pivot/medial stabilised total knee systems currently on the market using the Australian Orthopaedic Association National Joint Replacement Registry (AOANJRR) data. This includes other medial pivot/ medial stabilised total knee systems found in the AOANJRR Registry such as the GMK Sphere Primary, Evolution, SAIPH, Advance II, Advance and MRK. The registry defines Medial pivot design prostheses to have a ball and-socket medial portion of the articulation.
The comparison to the AOANJRR will utilise the cumulative percent revision (CPR), which is the complement of the Kaplan-Meier survivorship function. Mean differences in patient reported outcomes measure (PROM) scores (EuroQol five-dimensional scale questionnaire(EQ-5D-5L), Oxford Knee Score (OKS), Visual Analogue Scale (VAS) and Forgotten Joint Score (FJS)) will be obtained pre-surgery and again at 1 year, 2 year , 5 years and 10 years post procedure to evaluate the extent of improvement/reduction in patient quality of life, level of pain, satisfaction and rate of complications, compared to scores obtained prior to surgery. There is no plan for these mean PROMS scores to be compared/analysed with other commercially available competitor devices.
Control group
Active

Outcomes
Primary outcome [1] 332131 0
The primary outcome of the study is to determine the GMK SpheriKA total knee device survival at 2-years post-operatively compared to all other medial pivot knee systems utilising the AOANJRR data revision rates. Kaplan-Meier estimates of survivorship will be used to describe the time to first revision of the GMK SpheriKA knee system.
Timepoint [1] 332131 0
2-years post-surgery
Secondary outcome [1] 412310 0
Mean scores on patient reported outcome questionnaire EQ-5D-5L. This questionnaire is a standardised measure of patient health status and quality of life.
Timepoint [1] 412310 0
Preoperatively, then 6 months, 1 year, 2-years, 5 years, and 10 years post-surgery
Secondary outcome [2] 412311 0
Mean scores on patient reported outcome questionnaire Forgotten Joint Score
Timepoint [2] 412311 0
6 months, 1 year, 2-years, 5 years, and 10 years post-surgery
Secondary outcome [3] 412312 0
Mean scores on patient reported outcome questionnaire Oxford Knee Score (OKS)
Timepoint [3] 412312 0
Preoperatively, then 6 months, 1 year, 2 years, 5 years and 10 years post-surgery
Secondary outcome [4] 412313 0
Mean scores on patient reported outcome questionnaire Visual Analogue Scale (VAS) for Pain
Timepoint [4] 412313 0
Preoperatively, then 6 months, 1 year, 2 years, 5 years and 10 years post-surgery
Secondary outcome [5] 412314 0
Radiological performance to see changes in the Hip-Knee-Ankle (HKA) using x-rays.
Timepoint [5] 412314 0
Preoperatively then 6 weeks, 6 months, 1 year, and 2-years post-surgery
Secondary outcome [6] 413931 0
Radiological performance to see changes in the Mechanical medial posterior tibial angle (mMPTA) using x-rays.
Timepoint [6] 413931 0
Preoperatively then 6 weeks, 6 months, 1 year, and 2-years post-surgery
Secondary outcome [7] 413932 0
Radiological performance to see changes in the Mechanical lateral distal femoral angle (mLDFA) using x-rays.
Timepoint [7] 413932 0
Preoperatively then 6 weeks, 6 months, 1 year, and 2-years post-surgery

Eligibility
Key inclusion criteria
• Patients undergoing a primary total knee replacement according to the indications for use (On-Label use).
• Patients with intact collateral ligaments
• Patients ability to use a mobile phone app to answer the questionnaires
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria

• Patients with inflammatory arthritis.
• BMI >40
• Patients with a history of total or unicompartmental reconstruction of the affected joint.
• Patients that have had a high tibial osteotomy or femoral osteotomy.
• Patients with neuromuscular or neurosensory deficiency,
• Patients with bad chronic disease
• Previous instability of patello-femoral joint/previous surgery for patello-femoral stabilisation
• Patients that are immunologically compromised
• Patients presenting with emergency procedures
• Patients with an intellectual or physical disability preventing them from using the APP.
• Patients that do not own a smart phone or device will need to be excluded from the study.

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
The data collected for the SpheriKA study cohort will be compared to available data on other Medial pivot/stabilised total knee.
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Kaplan-Meier estimates of survivorship will be used to describe the time to first revision of the GMK SpheriKA knee system. The study metric will be defined as the cumulative percent revision (CPR) at specified years which is the complement (in probability) of the Kaplan-Meier estimates, multiplied by 100. Cumulative percent revision is defined as 100 x [1- S(t)] where S(t) is the survivorship probability estimated by the Kaplan-Meier method. Non-Inferiority is established if the higher 95% confidence interval for the SpherikA doesn’t exceeds of 2% the 2-year CPR for all other Medial Pivot Designs.
The secondary analysis is to investigate the safety and performance of the Medacta GMK SpheriKA by evaluating knee function, pain, satisfaction, and the quality of life using standardised instruments. The instruments that will be used for the study are OKS, FJS, VAS (lower leg), and EQ-5D-5L. Data we will use paired t-test for continuous variables and Wilcoxon signed-rank test for categorical variables. To assess possible presence of bias we will conduct sensitivity analyses. We will perform all tests two tailed and consider p=0.05 as statistically significant.
Correlation will be measured using Pearson’s correlation coefficient where both the variables are continuous. In case the variable is categorical one-way ANOVA will be performed, followed by Tukey’s multiple comparison tests. All analysis will be adjusted for age, gender, and BMI. Best-case survivorship curves were calculated (1-Kaplan-Meier estimates) with failure defined as all-cause revision, and patients who withdrew or died were considered as having implants that remained in situ but censored at those time points. The survivorship data from this study will be compared with the AOANJRR survivorship data against other performing kinematically aligned medial pivot/medial stabilised total knee replacements.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
30/09/2022
Actual
Date of last participant enrolment
Anticipated
30/09/2024
Actual
Date of last data collection
Anticipated
30/09/2034
Actual
Sample size
Target
280
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC
Recruitment hospital [1] 23144 0
Lingard Private Hospital - Merewether
Recruitment hospital [2] 23145 0
St Andrew's Hospital Inc - Adelaide
Recruitment hospital [3] 23146 0
Epworth Richmond - Richmond
Recruitment hospital [4] 23147 0
John Hunter Hospital - New Lambton
Recruitment postcode(s) [1] 38503 0
2291 - Merewether
Recruitment postcode(s) [2] 38504 0
5000 - Adelaide
Recruitment postcode(s) [3] 38505 0
3121 - Richmond
Recruitment postcode(s) [4] 38506 0
2305 - New Lambton

Funding & Sponsors
Funding source category [1] 311933 0
Commercial sector/Industry
Name [1] 311933 0
Medacta Australia Pty Ltd
Country [1] 311933 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Medacta Australia Pty Ltd
Address
Unit A1, 16 Mars Road, Lane Cove, NSW 2066
Country
Australia
Secondary sponsor category [1] 313411 0
None
Name [1] 313411 0
Address [1] 313411 0
Country [1] 313411 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311366 0
Hunter New England Human Research Ethics Committee
Ethics committee address [1] 311366 0
Hunter New England Local Health District Head Office - Newcastle
Lookout Road
New Lambton NSW 2305
Postal Address:
Locked Bag 1
New Lambton NSW 2305
Ethics committee country [1] 311366 0
Australia
Date submitted for ethics approval [1] 311366 0
09/02/2022
Approval date [1] 311366 0
18/05/2022
Ethics approval number [1] 311366 0
2022/ETH00335

Summary
Brief summary
The GMK® SpheriKA is a total knee replacement device developed by Medacta International SA as a product line extension of the GMK® Sphere femoral component (class III CE marked). GMK® Sphere has been on the market since 2011. The design of the SpheriKA femoral components is optimized for the kinematic alignment technique, with particular focus on those cases when the position of the femoral component may represent a challenge for the patella tracking.
The purpose of the study is to assess the clinical effectiveness and survivorship of the GMK SpheriKA device. This will be achieved by; evaluating patient reported outcome measures (PROMs), clinical outcomes, radiological outcomes and survivorship. Medacta may use the results of this project in their application to the Prosthesis List Advisory Committee (PLAC) for assessment. The GMK SpheriKA is not yet listed on “the Prosthesis List”.
A patient reported outcome measure (PROM) is defined as any report of a patient’s health status that comes directly from the patient without the interpretation by others. Incorporating PROMs not only enables the inclusion of this unique and critically important perspective of the patient’s opinion, but also broadens the range of outcomes that can be evaluated. With specific regard to joint replacement, PROMS can provide meaningful information on the extend of pain and disability prior to surgery, as well as the extent and timing of recovery and the presence of complications. The successful collection, knowledgeable interpretation and integration of PROMs with other outcomes can improve the benefit and cost effectiveness of health care delivery.
The hypothesis is that the 2-year survivorship for the GMK SpheriKA knee system is not inferior to the survivorship rate of the other medial pivot knee designs.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 120846 0
Dr Jorgen Hellman
Address 120846 0
Dr Jorgen Hellman Hip and Knee Orthopaedic Surgeon
Suite 2, 18 Lambton Road
Broadmeadow, NSW 2292
Country 120846 0
Australia
Phone 120846 0
+61 2 4969 8275
Fax 120846 0
Email 120846 0
[email protected]
Contact person for public queries
Name 120847 0
Selin Kulaga
Address 120847 0
Medacta Australia Pty Ltd
Unit A1, 16 Mars Road Lane Cove NSW 2066
Country 120847 0
Australia
Phone 120847 0
+61 1300 361 790
Fax 120847 0
Email 120847 0
[email protected]
Contact person for scientific queries
Name 120848 0
Jorgen Hellman
Address 120848 0
Dr Jorgen Hellman Hip and Knee Orthopaedic Surgeon
Suite 2, 18 Lambton Road
Broadmeadow, NSW 2292
Country 120848 0
Australia
Phone 120848 0
+61 2 4969 8275
Fax 120848 0
Email 120848 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
To maintain patient confidentiality and comply with international privacy laws, individual participant data will not be available for this trial.


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.