Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000416796p
Ethics application status
Submitted, not yet approved
Date submitted
25/02/2022
Date registered
11/03/2022
Date last updated
11/03/2022
Date data sharing statement initially provided
11/03/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
RaMeiKin - A Prospective Randomised Control Trial Comparing the Effect of Mechanical and Inverse Kinematic Alignment on Clinical and Function Outcomes after Total Knee Replacement
Scientific title
A Randomised Study comparing the clinical and functional outcomes of mechanical and inverse kinematic alignment for Total Knee Replacement (RaMeiKin).
Secondary ID [1] 306515 0
None
Universal Trial Number (UTN)
Trial acronym
RaMeiKin
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Osteoarthritis of the knee 325383 0
Total Knee Replacement 325384 0
Condition category
Condition code
Musculoskeletal 322766 322766 0 0
Osteoarthritis
Surgery 322868 322868 0 0
Surgical techniques

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients will receive their total knee replacement according to inverse kinematic alignment principles. The implant will be aligned using computer navigated surgery.
Kinematic principles position the knee replacement in a way that respects the natural joint line and rotational axis of the knee. Each surgery will take approximately 2 hours. The surgeons performing the surgeries have a be fellowship trained in knee arthroplasty. Post-operative alignment will be confirmed using CT and long-leg radiographs
Intervention code [1] 322942 0
Treatment: Devices
Intervention code [2] 323015 0
Treatment: Surgery
Comparator / control treatment
Patients who have been randomised to this group will have their knee replacement aligned using the mechanical alignment philosophy. This is the more traditional way and places the implant perpendicular to the mechanical axis. This group will also receive the same implant (Genus Knee) as the KA group. The length of surgery will be the similar as those randomised to the intervention (KA) group. This group will also have their alignment confirmed using post-operative CT and radiographs

Eligible patients who are unwilling to be included in the randomised arm of the study will be invited to participate in the observational arm of usual practice. This group will be given either mechanical or kinematic alignment, depending on the surgeon's preference. They will be assessed at their 6 week follow-up for complications and then at 6, 12 and 24 months post surgery. These participants recieving online questionnaires taking approx. 30 minutes in total.
Control group
Active

Outcomes
Primary outcome [1] 330569 0
Patient Reported Outcome measured using the Oxford Knee Score
Timepoint [1] 330569 0
Baseline, and 6, 12 ,and 24 months (primary endpoint) post-surgery
Primary outcome [2] 330570 0
Satisfaction Visual Analogue Score (VAS)
Timepoint [2] 330570 0
Baseline, and 6, 12 ,and 24 months (primary endpoint) post-surgery
Secondary outcome [1] 406717 0
Joint awareness as measure by the Forgotten Joint Score (FJS)
Timepoint [1] 406717 0
Baseline, and 6, 12, and 24 months post-surgery
Secondary outcome [2] 406718 0
2D-3D image registration derived 6-degree-of-freedom kinematics during kneeling
Timepoint [2] 406718 0
Baseline, 12 and 24 months post-surgery
Secondary outcome [3] 406719 0
2D-3D image registration derived 6-degree-of-freedom kinematics during stair ascent
Timepoint [3] 406719 0
baseline, 12 months, 24 months post-surgery
Secondary outcome [4] 407086 0
Knee biomechanics capture by marker-based motion capture
Timepoint [4] 407086 0
baseline, 12 months, and 24 months post-surgery

Eligibility
Key inclusion criteria
Independently mobile
Osteoarthritis
On surgical waiting list for a primary total knee replacement
Available for follow up at 6 weeks, 6, 12 and 24 months
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patient unable to provide consent (due to reduced cognitive capacity or lack of English proficiency).
Previous neurological or musculoskeletal condition (excluding knee injury) which has affected physical performance.
Patients who have had significant prior surgery or trauma to the affected knee (e.g. prior High Tibial Osteotomy, periarticular fracture, recurrent patella dislocation)

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)
Central randomisation by computer (RedCap). Participants will be blinded to their randomisation group. The surgeon will be unblinded.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated Permuted block randomisation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Other
Other design features
Participants will be randomised to either the intervention (KA) or control (MA) group. Participants who decline to be randomised will be allocated to an oberservational group (i.e. standard care)
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/04/2022
Actual
Date of last participant enrolment
Anticipated
1/04/2024
Actual
Date of last data collection
Anticipated
1/04/2026
Actual
Sample size
Target
440
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW

Funding & Sponsors
Funding source category [1] 310860 0
Commercial sector/Industry
Name [1] 310860 0
Adler Orthopaedics
Country [1] 310860 0
Australia
Primary sponsor type
Hospital
Name
Trauma and Orthopaedic Research Unit, Canberra Health Services
Address
Building 6, Level 1
The Canberra Hospital
Garran, ACT, 2605
Country
Australia
Secondary sponsor category [1] 312117 0
Commercial sector/Industry
Name [1] 312117 0
Adler Orthopaedics
Address [1] 312117 0
Unit 2/61 Southgate Ave
Cannon Hill QLD, 4160
Country [1] 312117 0
Australia

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 310422 0
ACT Health Human Research Ethics Committee
Ethics committee address [1] 310422 0
The Canberra Hospital
Yamba Dr
Garran, ACT, 2605
Ethics committee country [1] 310422 0
Australia
Date submitted for ethics approval [1] 310422 0
04/01/2022
Approval date [1] 310422 0
Ethics approval number [1] 310422 0

Summary
Brief summary
This study is a prospective, randomized, longitudinal study of the clinical and biomechanical outcomes of osteoarthritis patients treated by two different alignment philosophies for total knee replacement. All patients will be treated with the same knee system, implanted using nagivated assisted technology.

We hypothosize that Inverse Kinematic alignment (iKA) will result in better Oxford Knee score (OKS) and satisfaction visual analogue scale (VAS) score compared to mechanical alignment (MA).
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 117610 0
Prof Paul Smith
Address 117610 0
The Trauma and Orthopaedic Research Unit
Building 6 Level 1
The Canberra Hospital
Yamba Drive
Garran, ACT, 2605
Country 117610 0
Australia
Phone 117610 0
+61 02 6221 9327
Fax 117610 0
Email 117610 0
psmith.admin@orthoact.com.au
Contact person for public queries
Name 117611 0
Dr Joe Lynch
Address 117611 0
The Trauma and Orthopaedic Research Unit
Building 6 Level 1
The Canberra Hospital
Yamba Drive
Garran, ACT, 2605
Country 117611 0
Australia
Phone 117611 0
+61 02 5124 3873
Fax 117611 0
Email 117611 0
joe.lynch@act.gov.au
Contact person for scientific queries
Name 117612 0
Dr Joe Lynch
Address 117612 0
The Trauma and Orthopaedic Research Unit
Building 6 Level 1
The Canberra Hospital
Yamba Drive
Garran, ACT, 2605
Country 117612 0
Australia
Phone 117612 0
+61 02 5124 3873
Fax 117612 0
Email 117612 0
joe.lynch@act.gov.au

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.