Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000289819
Ethics application status
Approved
Date submitted
22/10/2020
Date registered
16/03/2021
Date last updated
16/03/2021
Date data sharing statement initially provided
16/03/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
Multi-centre, observational study assessing clinical outcomes and patient satisfaction using kinematic alignment techniques for total knee replacement procedures.
Scientific title
Multi-centre, observational study assessing clinical outcomes and patient satisfaction using kinematic alignment techniques for total knee replacement procedures.
Secondary ID [1] 302575 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Knee Osteoarthritis 319462 0
Condition category
Condition code
Musculoskeletal 317429 317429 0 0
Osteoarthritis

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Total Knee Arthroplasty (TKA) is a common intervention administered to treat severe degenerative knee joint disease conditions (such as osteoarthritis). Traditionally, prosthetic joint components have been implanted to be aligned with the mechanical axis of the femur and tibia. This is done in an attempt to restore neutral overall limb alignment and ensure long term implant survival. However, the clinical utility of this approach has recently been questioned with the introduction of kinematic alignment techniques.

The concept of kinematic alignment (KA) aims to position TKA implants to match the pre-arthritic anatomy of each individual patient. KA advocates suggest this will improve soft tissue balancing, reduce the need for ligament releases, and enhance functional outcome following TKA.

All patients being considered for enrollment in this trial will be undergoing TKR as per usual treatment management plans provided by their referring clinician. Surgery will take place in accredited public hospital surgical theatre by qualified orthopedic surgeons. As part of the TKA procedure, the patients will be implanted with a TGA Approved artificial knee joint prosthesis using kinematic alignment surgical techniques.

All patients participating in the trial will be observed over a period of 10 years on the performance of their knee replacement, their degree of movement and satisfaction with their surgery. These parameters will be assessed using the following measures:

1) Patient Reported Outcomes Measures. These consists of several questionnaires including the Forgotten Joint Score, Oxford Knee Score, Knee Injury and Osteoarthritis Score, Visual Analog Satisfaction Score. Participants will be asked to complete the abovementioned questionnaires at seven time points as part of standard of care follow-up consults for TKA (pre-operatively, and again at 9-weeks, 6-months, 1year, 2-years, 5 years and 10-years post surgery). It is anticipated that it will take approximately 15 minutes to complete each set of questionnaires at each time point. These questionnaires will be administered by the either the surgeon or surgeon's administrator during face-to-face consults.

2) Radiological Assessments. Standard x-rays will be taken at seven time points as part of standard of care procedures for TKA to ensure implants are positioned well and functioning as required (pre-operatively, 9-weeks, 6-months, 1 year, 2 years, 5years and 10 years post-surgery). Pre-operative radiological evaluation of the following angles will be determined and compared 6-months post-surgery to confirm native knee angle restoration.
- Mechanical alignment of the limb as the angle between a line connecting the mechanical axes of the femur and tibia (HKA)
- Mechanical medial proximal tibial angle (mMPTA)
- Mechanical lateral distal femur angle (mLDFA)
All radiological assessments will be done by a Radiologist at the surgeon's preferred radiology practice.
Intervention code [1] 318881 0
Not applicable
Comparator / control treatment
This is an observational study so there is no comparator arm
Control group
Uncontrolled

Outcomes
Primary outcome [1] 325481 0
Mean Oxford Knee Questionnaire Scores (OKS) to assess function and pain after total knee replacement.
Timepoint [1] 325481 0
2 years post-surgery
Secondary outcome [1] 388083 0
Mean Knee Injury and Osteoarthritis Outcome Scores (KOOS)
Timepoint [1] 388083 0
9 weeks, 6 months, 1 year, 2 years, 5 years and 10 years post-surgery
Secondary outcome [2] 388084 0
Mean Oxford Knee Questionnaire Scores (OKS) to assess function and pain after total knee replacement.
Timepoint [2] 388084 0
9 weeks, 6 months, 1 year, 5 year and 10 years post-surgery
Secondary outcome [3] 388085 0
Mean Range of Motion Scores (ROM) will be assessed using a goniometer.
Timepoint [3] 388085 0
9 weeks. 6 months, 1 year, 2 years, 5 years and 10 years post-surgery
Secondary outcome [4] 388086 0
Mean Forgotten Joint Questionnaire Scores (FJS)
Timepoint [4] 388086 0
6 months, 1 year, 2 years, 5 years and 10 years post-surgery
Secondary outcome [5] 388087 0
Mean Visual Analogue Satisfaction Score (VAS)
Timepoint [5] 388087 0
6 months, 1 year, 2 years, 5 years and 10 years post surgery
Secondary outcome [6] 388088 0
Radiological evaluation of knee angles. This includes determining the differences between the pre-operative and post-operative angle of the line connecting the mechanical axes of the femur and tibia (HKA). This will be determined through comparison of x-ray images.
Timepoint [6] 388088 0
Pre-operative and 6 months post-surgery (difference)
Secondary outcome [7] 390811 0
Radiological evaluation of knee angles. This includes determining the differences between the pre-operative and post-operative angle of the line connecting the mechanical axes of the femur and the medial proximal tibial angle (mMPTA). This will be determined through comparison of x-ray images.
Timepoint [7] 390811 0
Pre-operative and 6 months post-surgery (difference)
Secondary outcome [8] 390812 0
Radiological evaluation of knee angles. This includes determining the differences between the pre-operative and post-operative angle of the line connecting the mechanical axes of the femur and lateral distal femur angle (mLDFA). This will be determined through comparison of x-ray images.
Timepoint [8] 390812 0
Pre-operative and 6 months post-surgery (difference)

Eligibility
Key inclusion criteria
-Patients with a previous diagnosis of end-stage osteoarthritis who have undergone primary total knee arthoplasty using kinematic alignment techniques.
- Patients who understand the study conditions and are willing/able to provide written consent for participation in the study.
- Patients who received a GMK Sphere Medacta Medially Stablised Knee Implant based on on-label usage.
- Aged over 18 years
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Patients who experienced an adverse event post-surgery unrelated to device implant
- Patients with a history or are currently being treated for psychiatric illness/mental disorder
- Evidence of either acute or chronic infection either pre or post-surgery
- Patients who have had significant prior surgery or trauma to the affected knee (e.g. prior High Tibial Osteotomy, periarticular fracture, recurrent patella dislocation)
- Patients with a history or are currently being treated for alcohol or drug abuse

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Both
Statistical methods / analysis
Correlations will be assessed through a linear regression and R coefficients will be calculated. Descriptive statistics will be reported for all variables. Continuous variables will be presented as means, standard deviations (SD), confidence intervals, medians, minimum and maximum, while categorical variables will be reported as frequency and confidence intervals.
Primary Analyses
- The differences between pre-operative and post-operative HKA post-surgery will be correlated with patient outcome measure scores obtained in the OKS questionnaire at 2 years.
Secondary Analyses
- The differences between pre-operative and post-operative HKA will be correlated with patient outcome measure scores obtained in each of the Forgotten Joint Score, KOOS and VAS questionnaires at each time point.
- The difference between pre-operative and post-operative mMPTA will be correlated with patient outcome measure scores obtained in each of the Forgotten Joint Score, OKS, KOOS and VAS questionnaires at each time point.
- The difference between pre-operative and post-operative mLDFA will be correlated with patient outcome measure scores obtained in each of the Forgotten Joint Score, OKS, KOOS and VAS questionnaires at each time point.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
17/06/2020
Date of last participant enrolment
Anticipated
30/12/2021
Actual
Date of last data collection
Anticipated
30/12/2031
Actual
Sample size
Target
150
Accrual to date
50
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 17866 0
John Hunter Hospital - New Lambton
Recruitment hospital [2] 17867 0
Lingard Private Hospital - Merewether
Recruitment postcode(s) [1] 31723 0
2305 - New Lambton
Recruitment postcode(s) [2] 31724 0
2291 - Merewether

Funding & Sponsors
Funding source category [1] 307007 0
Commercial sector/Industry
Name [1] 307007 0
Medacta Australia Pty Ltd
Country [1] 307007 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] 307599 0
None
Name [1] 307599 0
Address [1] 307599 0
Country [1] 307599 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307139 0
Hunter New England Research Ethics Committee
Ethics committee address [1] 307139 0
Ethics committee country [1] 307139 0
Australia
Date submitted for ethics approval [1] 307139 0
26/02/2020
Approval date [1] 307139 0
03/03/2020
Ethics approval number [1] 307139 0
2020/ETH0206

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

Contacts
Principal investigator
Name 106170 0
Dr Jorgen Hellman
Address 106170 0
Dr Jorgen Hellman Private Rooms
2/18 Lambton Road
Broadmeadow NSW 2292

Lingard Private Hospital
23 Merewether Street
Merewether NSW 2291

John Hunter Hospital
Lookout Road,
New Lambton Heights NSW 2305
Country 106170 0
Australia
Phone 106170 0
+61 2 49698275
Fax 106170 0
Email 106170 0
[email protected]
Contact person for public queries
Name 106171 0
Jorgen Hellman
Address 106171 0
Dr Jorgen Hellman Private Rooms
2/18 Lambton Road
Broadmeadow NSW 2292

Lingard Private Hospital
23 Merewether Street
Merewether NSW 2291

John Hunter Hospital
Lookout Road,
New Lambton Heights NSW 2305
Country 106171 0
Australia
Phone 106171 0
+61 2 49698275
Fax 106171 0
Email 106171 0
[email protected]
Contact person for scientific queries
Name 106172 0
Victoria Dokic
Address 106172 0
Medacta Australia
Unit A1, 16 Mars Road
Lane Cove, NSW 2066
Country 106172 0
Australia
Phone 106172 0
+61 0430023535
Fax 106172 0
Email 106172 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.