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Trial registered on ANZCTR


Registration number
ACTRN12620000759998
Ethics application status
Approved
Date submitted
28/05/2020
Date registered
24/07/2020
Date last updated
24/07/2020
Date data sharing statement initially provided
24/07/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Comparison of patient pain levels between total knee replacement recipients who undergo kneecap resurfacing and those who don't.
Scientific title
Assessment of patient knee pain following randomised patellar resurfacing versus retention in anatomically designed total knee arthroplasty.
Secondary ID [1] 301395 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Osteoarthritis 317599 0
total knee replacement 317816 0
knee osteoarthritis 317817 0
Condition category
Condition code
Surgery 315679 315679 0 0
Surgical techniques
Musculoskeletal 315875 315875 0 0
Osteoarthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants enrolled in this study who are randomised to the intervention group will undergo resurfacing of their patella at the time of receiving a total knee replacement. Patients will receive the SAIPH(TM) knee system for their femoral and tibial components. The surgical technique for the total knee replacement will be as per the surgeon's preference of the manufacturer's recommendations. A total knee replacement procedure generally takes approximately 90 minutes, with an additional 10 minutes for patella resurfacing. This intervention will be delivered as a single stage surgery by an experienced knee arthroplasty surgeon at St John of God Hospital, Murdoch. Follow up will occur for 12 months after the intervention.
Intervention code [1] 317663 0
Treatment: Surgery
Comparator / control treatment
The comparator group for this study will undergo a total knee replacement, however the underside of the patella will not be resurfaced during the surgery. The comparator group will also receive the SAIPH(TM) knee system for their femoral and tibial components as a single stage surgery, implanted by an experienced knee arthroplasty surgeon at St John of God Hospital. The surgical technique for the total knee replacement will be as per the surgeon's preference of the manufacturer's recommendations.
Control group
Active

Outcomes
Primary outcome [1] 323911 0
The primary outcome of this study will be the patella specific Patient Reported Outcome Measure (PROM)- Kujala Anterior Knee Pain Score (AKPS) . The AKPS questionnaire with scores from 0 (worst) to 100 (best) specifically target patellofemoral symptoms, and has been validated in use on Total Knee Arthoplasty (TKA) patients.
Timepoint [1] 323911 0
Pre-operatively, six weeks post-operatively and twelve months post-operatively (primary timepoint).
Secondary outcome [1] 383295 0
The Oxford Knee Score (OKS) is widely used as a joint specific PROM which aims to reduce the influence of comorbidities. The OKS produces a score from 0-48, with higher numbers associated with better outcomes.
Timepoint [1] 383295 0
Pre-operatively, six weeks post-operatively and twelve months post-operatively.
Secondary outcome [2] 383296 0
The Patient Knee Implant Performance (PKIP) score is validated in the assessment of patients post TKA, PKIP has four subscales ( confidence, stability, modify activities and satisfaction), with each one generating a score from zero to 10, with higher scores indicating better knee function. The overall score ranges from zero to 100.
Timepoint [2] 383296 0
Pre-operatively, six weeks post-operatively and twelve months post-operatively.
Secondary outcome [3] 383297 0
The Forgotten Joint Score (FJS-12) is a validated 20 item, 0-5 point questionnaire assessing the patient’s ability to forget about their prosthetic joint in everyday life. Some items can be considered patellofemoral targeting questions such as symptoms whilst sitting for >1hr and climbing stairs. The "forgotten joint" eliminates any significant subjective impairments such as pain, instability or disabling range of motion. Thus, the FJS-12 is a relevant parameter to assess subjective joint function.
Timepoint [3] 383297 0
Six weeks post-operatively and twelve months post-operatively.
Secondary outcome [4] 383298 0
The Patients Global Impression of Change (PGIC) is a single question self-report measure and reflects a patient's belief about the efficacy of treatment.
Timepoint [4] 383298 0
Six weeks post-operatively and twelve months post-operatively.
Secondary outcome [5] 383741 0
Range of knee movement in terms of flexion and extension will be assessed and recorded in range of degrees by an experienced clinician.
Timepoint [5] 383741 0
Pre-operatively at booking visit, and at 6-weeks and 12-months post operatively.

Eligibility
Key inclusion criteria
1) Adult participants greater than >18 years of age
2) Participants undergoing primary knee arthroplasty for osteoarthritis with SAIPHTM knee system by Prof Piers Yates, Prof Gareth Prosser, A/Prof Christopher Jones or Mr Peter D’Alessandro
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1) Participants with poor English who are unable to complete the questionnaires and understand instructions
2) Bilateral TKA
3) Posttraumatic OA
4) Previous HTO previous TTO +/- MPFL
5) Previous patella dislocation
6) Rheumatoid/inflammatory arthritis
7) Dementia
8) Chronic pain not related to operative knee
9) Patients with significant patella maltracking as diagnosed by the treating surgeon

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)
Allocation concealed via sealed opaque envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The participant will be randomised by computer generated block randomisation.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
All randomised participants will be included in the data analysis such that an intention-to-treat analysis will be performed, independent of protocol adherence.

Categorical data will be compared with the use of the chi-square test or the McNemar test for the comparisons of preoperative and postoperative data. The unpaired t-tests or the Mann-Whitney U tests will be used to analyze differences in continuous variables between the two treatment groups. Nonparametric statistics will be used for analysis of continuous variables when data were not normally distributed.

Cox proportional hazards regression analysis will be used to assess associations between potential explanatory variables, including patella resurfacing, and the Patient Global Impression of Change. The criteria for statistical significance will be set at p<0.05.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
31/07/2020
Actual
Date of last participant enrolment
Anticipated
29/07/2022
Actual
Date of last data collection
Anticipated
31/07/2023
Actual
Sample size
Target
80
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 16756 0
St John of God Hospital, Murdoch - Murdoch
Recruitment postcode(s) [1] 30378 0
6150 - Murdoch

Funding & Sponsors
Funding source category [1] 305805 0
Other Collaborative groups
Name [1] 305805 0
Orthopaedic Research Foundation of Western Australia (ORFWA)
Country [1] 305805 0
Australia
Primary sponsor type
Other Collaborative groups
Name
Orthopaedic Research Foundation of Western Australia (ORFWA)
Address
St John of God Murdoch Hospital
1 Barry Marshall Parade
Murdoch WA 6150
Country
Australia
Secondary sponsor category [1] 306247 0
None
Name [1] 306247 0
Address [1] 306247 0
Country [1] 306247 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306076 0
St John of God Health Care Human Research Ethics Committee
Ethics committee address [1] 306076 0
Ethics committee country [1] 306076 0
Australia
Date submitted for ethics approval [1] 306076 0
18/06/2020
Approval date [1] 306076 0
24/06/2020
Ethics approval number [1] 306076 0
1684

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

Contacts
Principal investigator
Name 102614 0
Prof Piers J. Yates
Address 102614 0
Orthopaedics WA, Wexford Medical Centre, Murdoch, Western Australia 6150
Country 102614 0
Australia
Phone 102614 0
+61 8 9431 3333
Fax 102614 0
Email 102614 0
piersyates@hotmail.com
Contact person for public queries
Name 102615 0
Heidi Wilson
Address 102615 0
Orthopaedics WA, Wexford Medical Centre, Murdoch, Western Australia 6150
Country 102615 0
Australia
Phone 102615 0
+61 0450501290
Fax 102615 0
Email 102615 0
heidi.wilson1@my.nd.edu.au
Contact person for scientific queries
Name 102616 0
Heidi Wilson
Address 102616 0
Orthopaedics WA, Wexford Medical Centre, Murdoch,Western Australia 6150
Country 102616 0
Australia
Phone 102616 0
+61 0450501290
Fax 102616 0
Email 102616 0
heidi.wilson1@my.nd.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
This is a single blinded study, so raw data is not able to be made publicly available.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
8103Study protocol    379889-(Uploaded-28-05-2020-14-43-57)-Study-related document.docx
8104Informed consent form    379889-(Uploaded-28-05-2020-09-37-21)-Study-related document.docx



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.