Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621001339842p
Ethics application status
Submitted, not yet approved
Date submitted
20/07/2021
Date registered
6/10/2021
Date last updated
6/10/2021
Date data sharing statement initially provided
6/10/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Differences in knee bone density in patients with knee osteoarthritis who receive either cemented or cementless total knee arthroplasty.
Scientific title
Differences in tibial bone remodeling between cemented and cementless total knee arthroplasty in knee osteoarthritis patients: A prospective randomized control trial.
Secondary ID [1] 304823 0
BMD-FIX-20
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Osteoarthritis 322896 0
Total Knee Arthroplasty 322897 0
Arthritis 322898 0
Knee Osteoarthritis 322899 0
Knee Arthritis 322900 0
Knee Surgery 322901 0
Condition category
Condition code
Musculoskeletal 320475 320475 0 0
Osteoarthritis
Surgery 320756 320756 0 0
Other surgery

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This trial assesses two types of total knee arthroplasty (TKA). Surgical intervention will be randomly allocated to participants (knee surgery patients with osteoarthritis of the knee). Participants will receive either the cemented or cementless device during their surgery.

The femoral component is manufactured from a Cobalt Chromium alloy whilst the tibial component is manufactured via a 3D printing process from Titanium powder. All bearing surfaces (patella and tibial insert) are manufactured from ultra-high molecular weight polyethylene and treated through a 3 stage sequential crosslinking and annealing process. Their treating surgeon will perform the operation, with a usual surgery duration of approximately one hour. The cemented devices used in this trial are listed below.

Cemented TKA system:
-Triathlon CR Cemented Femoral Component (5510-F-XXXX) – ARTG 212698
-Triathlon Cemented Tibial Baseplate (5520-B-XXX) – ARTG 217832
-Triathlon CR Tibial Insert - X3 (5530-G-XXX) – ARTG 216480
-Triathlon CS Tibial Insert - X3 (5531-G-XXX) – ARTG 218019
-Triathlon symmetric patella – X3 (5550-G-XXX) – ARTG 212702
-Triathlon asymmetric patella – X3 (5551-G-XXX) – ARTG 212701

Any surgical complications and side effects will be reported in the patient's medical notes by the treating surgeon and followed-up as needed, using the surgeon's clinical judgement.
Intervention code [1] 321198 0
Treatment: Devices
Comparator / control treatment
This trial assesses two types of total knee arthroplasty (TKA). Surgical intervention will be randomly allocated to participants (knee surgery patients with osteoarthritis of the knee). Participants will receive either the cemented or cementless device during their surgery. Their treating surgeon will perform the operation, with a usual surgery duration of approximately one hour. The cementless devices used in this trial are listed below.

Cementless TKA system:
-Triathlon CR PA Beaded Femoral Component (5517-F-XXXX) – ARTG 146118
-Triathlon Tritanium Tibial Baseplate (5536-B-XXX) – ARTG 281719
-Triathlon CR Tibial Insert - X3 (5530-G-XXX) – ARTG 216480
-Triathlon CS Tibial Insert - X3 (5531-G-XXX) – ARTG 218019
-Triathlon symmetric patella – X3 (5550-G-XXX) – ARTG 284593
-Triathlon asymmetric patella – X3 (5551-G-XXX) – ARTG 284592

Any surgical complications and side effects will be reported in the patient's medical notes by the treating surgeon and followed-up as needed, using the surgeon's clinical judgement.
Control group
Active

Outcomes
Primary outcome [1] 328308 0
Compare the percentage differences in BMD (assessed using DXA) for region of interest 1, between the Triathlon cemented and cementless tibial baseplate. Region 1 focuses on the proximal medial part of the tibial baseplate, approximately 5 mm distal to the baseplate and excludes cortical bone on the medial aspect.
Timepoint [1] 328308 0
The outcomes will be measured pre-operatively (baseline), then again at 6-weeks, 1-year and 2-year post-operatively, with the 2-year follow up assessment being the primary timepoint.
Primary outcome [2] 328563 0
Compare the percentage differences in BMD (assessed using DXA) for region of interest 2, between the Triathlon cemented and cementless tibial baseplate. Region 2 focuses on the distal part of the tibial baseplate, approximately 5mm distal to the base of the keel.
Timepoint [2] 328563 0
The outcomes will be measured pre-operatively (baseline), then again at 6-weeks, 1-year and 2-year post-operatively, with the 2-year follow up assessment being the primary timepoint.
Primary outcome [3] 328564 0
Compare the percentage differences in BMD (assessed using DXA) for region of interest 3, between the Triathlon cemented and cementless tibial baseplate. Region 3 focuses on the proximal lateral part of the tibial baseplate, approximately 5 mm distal to the baseplate and excludes cortical bone on the lateral aspect.
Timepoint [3] 328564 0
The outcomes will be measured pre-operatively (baseline), then again at 6-weeks, 1-year and 2-year post-operatively, with the 2-year follow up assessment being the primary timepoint.
Secondary outcome [1] 398524 0
Compare functional outcomes within and between each group (cemented and cementless TKA) using the University of California at Los Angeles Activity Score Knee Injury and Osteoarthritis Outcome Score (KOOS) (UCLA).
Timepoint [1] 398524 0
At Baseline (pre-operative), and post-operative study assessments: 6-week, 1-year and 2-year follow up.
Secondary outcome [2] 398525 0
Compare pain outcomes within and between each group (cemented and cementless TKA) using the visual analog scale of pain (VAS).
Timepoint [2] 398525 0
At Baseline (pre-operative), and post-operative study assessments: 6-week, 1-year and 2-year follow up.
Secondary outcome [3] 398526 0
Compare the incidence of knee related adverse events between cemented and cementless TKA. Any surgical complications and side effects will be reported in the patient's medical notes by the treating surgeon and followed-up as needed, using the surgeon's clinical judgement. The following side effects occur in less than 1% of these TKA procedures, but when they do occur may require a revision procedure: implant loosening, infection, instability, pain, bone fracture, and implant breakage. The most common problems associated with anaesthesia post-surgery are feeling unwell or vomiting, bruising at the site of injections, sore throat or hoarse voice.
Timepoint [3] 398526 0
Post-operative study assessments at 6-week, 1-year and 2-year follow up.
Secondary outcome [4] 399434 0
Primary Outcome: Compare the percentage differences in bone mineral content (BMC; assessed using DXA) for region of interest 1, between the Triathlon cemented and cementless tibial baseplate. Region 1 focuses on the proximal medial part of the tibial baseplate, approximately 5 mm distal to the baseplate and excludes cortical bone on the medial aspect.
Timepoint [4] 399434 0
The outcomes will be measured pre-operatively (baseline), then again at 6-weeks, 1-year and 2-year post-operatively, with the 2-year follow up assessment being the primary timepoint.
Secondary outcome [5] 399435 0
Primary Outcome: Compare the percentage differences in BMC (assessed using DXA) for region of interest 2, between the Triathlon cemented and cementless tibial baseplate. Region 2 focuses on the distal part of the tibial baseplate, approximately 5mm distal to the base of the keel.
Timepoint [5] 399435 0
The outcomes will be measured pre-operatively (baseline), then again at 6-weeks, 1-year and 2-year post-operatively, with the 2-year follow up assessment being the primary timepoint.
Secondary outcome [6] 399436 0
Primary Outcome: Compare the percentage differences in BMC (assessed using DXA) for region of interest 3, between the Triathlon cemented and cementless tibial baseplate. Region 3 focuses on the proximal lateral part of the tibial baseplate, approximately 5 mm distal to the baseplate and excludes cortical bone on the lateral aspect.
Timepoint [6] 399436 0
The outcomes will be measured pre-operatively (baseline), then again at 6-weeks, 1-year and 2-year post-operatively, with the 2-year follow up assessment being the primary timepoint.
Secondary outcome [7] 399440 0
Compare the clinical outcomes within and between each group (cemented and cementless TKA) using the Oxford Knee Score (OKS).
Timepoint [7] 399440 0
The outcomes will be measured pre-operatively (baseline), then again at 6-weeks, 1-year and 2-year post-operatively.
Secondary outcome [8] 399441 0
Compare the clinical outcomes within and between each group (cemented and cementless TKA) using the Forgotten Joint Score (FJS).
Timepoint [8] 399441 0
The outcomes will be measured at 6-weeks, 1-year and 2-year post-operatively.
Secondary outcome [9] 399442 0
Compare the clinical outcomes within and between each group (cemented and cementless TKA) using the EuroQol (EQ-5D).
Timepoint [9] 399442 0
The outcomes will be measured pre-operatively (baseline), then again at 6-weeks, 1-year and 2-year post-operatively.

Eligibility
Key inclusion criteria
1. The patient is a male or non-pregnant female.
2. The patient suffers from osteoarthritis.
3. The patient has signed the study specific, HREC-approved, Informed Consent document and is willing and able to comply with the specified pre-operative and post-operative clinical and radiographic evaluations.
4. The patient is a suitable candidate for a Cruciate Retaining cementless TKA (based on the Investigator’s clinical judgment).
5. The patient only requires uni-lateral TKA (rather than bilateral TKA).
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. The patient has a systemic or local condition that would limit the ability to assess the performance of the device e.g. neuromuscular or neurosensory deficiency, disorder leading to progressive bone deterioration (including rheumatoid arthritis and osteoporosis), or the patient is immunologically suppressed.
2. The 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.

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)
Trial allocation will be concealed to the Surgical Study Investigators, who will not be involved in the sequence generation or allocation of participants to surgical intervention. The Surgical Study Investigators will receive the allocation from the Study Coordinator after registering the patient, screening and consenting them into the study.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Prior to recruitment commencing, the Co-Investigator or Study Coordinator will use a random number generator to sequence surgical allocation (using block randomisation with a block size of 4) and to create participant ID. As the surgeon statistically represents a random effect in the data, each of the three surgeons will be required to enrol an equal number of patients (20 participants per surgeon; 10 will receive cemented and 10 will receive cementless devices). The Co-Investigator and Coordinator will have keep a master list linking surgical allocation with participant ID on the secure Monash University network, in a study specific folder with access restricted only to research staff (not available to Surgical Investigators).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Data will be analysed by the Monash Biostatistical Consulting Platform. Surgical allocation will be coded in the dataset provided for analysis. Therefore the Data Analyst will be blinded to the allocation of cemented and cementless TKA until a manuscript is prepared for publication.
For the primary aim:
Descriptive statistics will be produced to characterise the percentage differences (for each ROI) in BMD and BMC between the cemented and cementless tibial baseplates at each time point. Comparison between each group will be measured using the Mann-Whitney U test.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/11/2021
Actual
Date of last participant enrolment
Anticipated
31/10/2022
Actual
Date of last data collection
Anticipated
31/10/2024
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 20036 0
Monash Medical Centre - Moorabbin campus - East Bentleigh
Recruitment postcode(s) [1] 34744 0
3165 - East Bentleigh

Funding & Sponsors
Funding source category [1] 309196 0
Hospital
Name [1] 309196 0
Monash Health
Country [1] 309196 0
Australia
Funding source category [2] 309709 0
University
Name [2] 309709 0
Monash University
Country [2] 309709 0
Australia
Funding source category [3] 309710 0
Commercial sector/Industry
Name [3] 309710 0
Stryker Australia Pty Ltd
Country [3] 309710 0
Australia
Primary sponsor type
Hospital
Name
Monash Health
Address
246 Clayton Road, Clayton Victoria 3168
Country
Australia
Secondary sponsor category [1] 310156 0
University
Name [1] 310156 0
Monash University
Address [1] 310156 0
Wellington Road, Clayton Victoria 3800
Country [1] 310156 0
Australia
Secondary sponsor category [2] 310730 0
Commercial sector/Industry
Name [2] 310730 0
Stryker Australia Pty ltd
Address [2] 310730 0
8 Herbert Street, St Leonards, NSW, 2065
Country [2] 310730 0
Australia

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 309050 0
Monash Health Human Research Ethics Committee
Ethics committee address [1] 309050 0
Monash Medical Centre
246 Clayton Road
Clayton
VIC 3168
Ethics committee country [1] 309050 0
Australia
Date submitted for ethics approval [1] 309050 0
21/07/2021
Approval date [1] 309050 0
Ethics approval number [1] 309050 0
Monash Health HREC Reference: RES-21-0000-497A

Summary
Brief summary
This is a bone mineral density (BMD) study using a dedicated analysis protocol to compare bone density around the surgical knee implant. in total knee arthroplasty (TKA).

Patients with osteoarthritis will be recruited prior to their TKA operation by their treating surgeon. Patients who participate have an equal chance of being allocated to the Triathlon cemented baseplate or the Triathlon cementless baseplate (Tritanium).

Clinical information, such as age, height, weight, ethnicity, general health, medications and medical conditions will be collected. Patient reported outcomes, functional activity, pain and adverse events will also be recorded.

The study involves four visits to Monash Medical Centre in Clayton which are additional to routine clinical appointments: before the operation, 6-weeks after, 12 months after and finally 24 months after the operation.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 112790 0
Prof Peter R Ebeling AO
Address 112790 0
Level 5 Block E
Monash Medical Centre
246 Clayton Road
Clayton VIC 3168
Country 112790 0
Australia
Phone 112790 0
+61 3 8572 2570
Fax 112790 0
+61 03 9905 9464
Email 112790 0
[email protected]
Contact person for public queries
Name 112791 0
Mr Cat Shore-Lorenti
Address 112791 0
Level 5 Block E
Monash Medical Centre
246 Clayton Road
Clayton VIC 3168
Country 112791 0
Australia
Phone 112791 0
+61 3 8572 2582
Fax 112791 0
+61 03 9905 9464
Email 112791 0
[email protected]
Contact person for scientific queries
Name 112792 0
Mr Cat Shore-Lorenti
Address 112792 0
Level 5 Block E
Monash Medical Centre
246 Clayton Road
Clayton VIC 3168
Country 112792 0
Australia
Phone 112792 0
+61 3 8572 2582
Fax 112792 0
+61 03 9905 9464
Email 112792 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
De-identified data only: all of the individual participant data collected during the trial may be shared. Data will be anonymised before sharing to protect the privacy of participants.
When will data be available (start and end dates)?
Data will be available following completion of the trial and analyses of primary and secondary outcomes. Data will be available for 2 years after publication.
Available to whom?
A request for de-identified participant data would need approval by study investigators, Stryker, Monash Health Human Research Ethics Committee for this trial and approval from the relevant ethics committee for the planned analysis of any shared data. A material transfer agreement would also be required to cover logistics and legalities across institutions/organisations.
Available for what types of analyses?
Analyses could include meta-analyses or original studies looking at one or both types of surgery for the same, similar or different outcomes.
How or where can data be obtained?
Requests for access can be submitted via email to Professor Peter R Ebeling AO: [email protected]. Please refer to the "TKA Bone Density Trial: RES-21-0000-497A" in the subject heading.


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.