Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000503729
Ethics application status
Approved
Date submitted
14/02/2022
Date registered
30/03/2022
Date last updated
17/05/2023
Date data sharing statement initially provided
30/03/2022
Type of registration
Retrospectively registered

Titles & IDs
Public title
A Clinical Investigation to evaluate the Apex KneeTM Pegged Tibial Baseplate Porous Coated components in primary Total Knee Arthroplasty using Roentgen Stereophotogrammetric Analysis (RSA)
Scientific title
A Clinical Investigation to evaluate the Apex KneeTM Pegged Tibial Baseplate Porous Coated components in primary Total Knee Arthroplasty using Roentgen Stereophotogrammetric Analysis (RSA) in patients with knee osteoarthritis
Secondary ID [1] 306326 0
Clinical Investigation Plan (CIP) ID: CSP 2020-01
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Total Knee Arthroplasty 325107 0
Condition category
Condition code
Musculoskeletal 322523 322523 0 0
Osteoarthritis
Surgery 322842 322842 0 0
Other surgery

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This is a pre-market, multi-centre, prospective, open label study to evaluate the safety and performance of the Apex Kneeâ„¢ Pegged Tibial Baseplate Porous Coated components used in combination with APEX Kneeâ„¢ CR femoral component. The Apex Kneeâ„¢ System is a Class III Orthopaedic device intended for use as a primary or revision Total Knee Replacement. It is approved by the Therapeutic Goods Administration and is listed on the prostheses list. The Apex Kneeâ„¢ Pegged Baseplate is a line extension to the existing Apex Kneeâ„¢ System and will serve as the tibial component of the primary total knee replacement in in this study. This study will be conducted under TGA Clinical Trial Notification Scheme (CTN) as the pegged baseplates are not yet approved for use in Australia. This clinical investigation aims to monitor the ongoing safety and performance of the Apex Kneeâ„¢ Pegged Baseplate Porous Coated components following primary total knee arthroplasty. Roentgen Stereophotogrammetric Analysis (RSA) will be performed post-operatively to monitor fixation over time.

In this study the eligible patients who will undergo primary total knee arthroplasty will be identified by the Orthopaedic surgeon from his patient database. The patients will be a given an information and consent form to read and sign. Following the signature, the patients will be assessed for suitability for participating in the study. Once they fit the criteria, they will be enrolled in the study. After enrolment the patients will complete some assessments and an X-ray. Medical History will be collected and physical health assessment will be done. They will also complete 3 quality-of-life questionnaires to assess their quality of life before the surgery.
On the day of the surgery the participants will receive the investigational device, Apex Kneeâ„¢ Pegged Porous Coated Cementless Baseplate for their knee surgery. The remaining components of the Apex Kneeâ„¢ System remain unchanged. The participants will have the option to have this implanted only if they are eligible/choose to enrol in the study.
The surgery will be completed by the Orthopaedic surgeons and will take about 2 hours. Before the surgery the surgeons will be trained on the surgical techniques. Before implanting the knee replacement, the surgeon will insert some very small metal beads (1mm in diameter, about 9 in total) into the bone surrounding the knee implant. These beads allow very accurate measurement of movement over time via a special X Ray technique called Roentgen Stereophotogrammetric X Ray (RSA). This will in turn help determine whether there are early signs of loosening or wear of your knee replacement

Following the surgery, the patient will complete the RSA while at the hospital before discharge. The patient will complete a few follow up visits over a span of 2 years where the safety and performance of the Apex Knee™ Pegged Baseplate will be measured by various assessments such as RSA radiological assessments, physical exams, range of movements (ROMs) and the quality-of-life questionnaires. Time points include 6 weeks, 6 months, 12 months and 2 years. Some of these follow up visits will be completed at the Orthopaedic surgeon’s office and some of these visits can be completed from home where the patients will be completing the questionnaires via paper, on their smart phone or computer. Throughout the study any adverse event that the patient may be experiencing will be reported to the Orthopaedic surgeon and his study team. The follow up study visits will take approximately 1-2 hours depending on the nature of the visit. The study team will send timely reminders to the participant ahead of the follow up visit.
Intervention code [1] 322758 0
Treatment: Surgery
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 330315 0
Migration (MTPM in mm) of the Tibial Base Plate with respect to the host bone measured by means of Roentgen Stereophotogrammetric analysis (RSA)
Timepoint [1] 330315 0
Post operatively within 0-6 days, and at 6 weeks, 6 months, 12 months and 24 months
Secondary outcome [1] 405764 0
Patient Reported Outcome will be measured using the Knee injury and Osteoarthritis Outcome Score, Joint Replacement (KOOS) Jr questionnaire. It is a short survey form measuring overall knee health for individuals post total knee arthroplasty (TKA) by evaluating stiffness, pain, function, and activities of daily living. It is a composite measure.
The KOOS, JR was developed from the original long version of the Knee injury and Osteoarthritis Outcome Score (KOOS) survey using Rasch analysis. The KOOS, JR contains 7 items from the original KOOS survey. Items are coded from 0 to 4, none to extreme respectively. Therefore the score is a composite score rather then being considered independently. (The full KOOS questionnaire as opposed to the KOOS JR looks at five different dimensions each scored separately with no single composite score)
Timepoint [1] 405764 0
Post-operatively at 6 weeks, 6 months, 12 months and 24 months.
Secondary outcome [2] 405765 0
Patient Reported Outcome measured using the EQ-5D-5L questionnaire which consists of the descriptive system and the EQ Visual Analogue Scale (EQ VAS). The descriptive system comprises of 5 Dimensions (5D), mobility, self care, usual activities, pain/discomfort, anxiety/depression separately.
Individual scores from the EQ-5D-5L descriptive system will be converted into a single index value (composite outcome) by combining 1 level from each of the 5 dimensions.
The EQ-VAS records the individual self-rated health on a 20cm vertical visual analogue scale . The response will be measured quantitatively.
Timepoint [2] 405765 0
Post-operatively at 6 weeks, 6 months, 12 months and 24 months.
Secondary outcome [3] 405766 0
Patient Reported Outcome measured using The Oxford Knee Score questionnaire. The Oxford Knee Score (OKS) is a 12-item patient-reported PRO specifically designed and
developed to assess function and pain after total knee replacement (TKR) surgery
(arthroplasty). It is short, reproducible, valid and sensitive to clinically important changes
Timepoint [3] 405766 0
Post-operatively at 6 weeks, 6 months, 12 months and 24 months.
Secondary outcome [4] 405767 0
Patient Reported Outcome measured using The Forgotten Joint Score questionnaire
This score will be used to measure patient satisfaction and ability to perform activities of daily living.
Timepoint [4] 405767 0
Post-operatively at 6 weeks, 6 months, 12 months and 24 months.
Secondary outcome [5] 405768 0
Participants overall satisfaction with surgery using Satisfaction Questionnaire. This is a standard questionnaire widely available for the joint replacement surgery.
Timepoint [5] 405768 0
Post-operatively at 6 weeks, 6 months, 12 months and 24 months.

Eligibility
Key inclusion criteria
1. Be over the age of 18 years, upper age limit is 80
2. Be capable of understanding the study requirements and of providing informed consent
3. Be eligible for a primary total knee replacement based on history, physical
examination and radiological evaluation.
4. Degenerative native knee-joint pathology
5. Adequate bone stock for uncemented tibial fixation
6. Agree to attend the research centre for the required post-operative assessments and radiological evaluation.
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Women who are pregnant or breast feeding or plan to become pregnant during the
course of the study.
2. Not willing or unable to return for required follow-up visits or clear demonstration of
likely poor compliance.
3. Any medical condition including current infections that in the judgement of the
investigator would prohibit the patient from participating in the study
4. Psychiatric or mental disorders, alcohol abuse or other substance abuse, which in
the opinion of the investigator would inhibit compliance with routine surgical followup.
5. The individual has a neuromuscular or neurosensory deficiency that limits the ability
to evaluate the safety and effectiveness of the device.
6. Previous patellectomy
7. The individual does not speak, read or comprehend the English language.

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
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
Actual
10/12/2021
Date of last participant enrolment
Anticipated
Actual
11/11/2022
Date of last data collection
Anticipated
31/12/2024
Actual
Sample size
Target
30
Accrual to date
Final
30
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 21613 0
Nepean Hospital - Kingswood
Recruitment postcode(s) [1] 36539 0
2747 - Kingswood

Funding & Sponsors
Funding source category [1] 310676 0
Commercial sector/Industry
Name [1] 310676 0
Corin Australia Pty Limited
Country [1] 310676 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Corin Australia Pty Limited
Address
17 Bridge Street
Pymble NSW 2073
Australia
Country
Australia
Secondary sponsor category [1] 311893 0
None
Name [1] 311893 0
Address [1] 311893 0
Country [1] 311893 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310264 0
Nepean Blue Mountain Local Health District HREC
Ethics committee address [1] 310264 0
Ethics committee country [1] 310264 0
Australia
Date submitted for ethics approval [1] 310264 0
27/07/2020
Approval date [1] 310264 0
05/11/2020
Ethics approval number [1] 310264 0
2020/ETH02000:

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 117050 0
Dr Simon Coffey
Address 117050 0
Simon Coffey Private Rooms
58A Derby Street
Kingswood NSW 2747
Country 117050 0
Australia
Phone 117050 0
+61 247 322 566
Fax 117050 0
Email 117050 0
[email protected]
Contact person for public queries
Name 117051 0
Anandita Roy
Address 117051 0
Corin Australia
17 Bridge Street
Pymble NSW 2073
Country 117051 0
Australia
Phone 117051 0
+61 2 9097 7400
Fax 117051 0
Email 117051 0
[email protected]
Contact person for scientific queries
Name 117052 0
Anandita Roy
Address 117052 0
Corin Australia
17 Bridge Street
Pymble NSW 2073
Country 117052 0
Australia
Phone 117052 0
+61 2 9097 7400
Fax 117052 0
Email 117052 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


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.