Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620000965909
Ethics application status
Approved
Date submitted
2/08/2020
Date registered
28/09/2020
Date last updated
28/09/2020
Date data sharing statement initially provided
28/09/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
The relationship between patient satisfaction and knee stability following total knee arthroplasty; a comparison between two commonly used implants.
Scientific title
The relationship between sagittal stability and patient reported outcome measures in patients following total knee arthroplasty (TKA) for osteoarthritis; a blinded comparison between a high congruency and low congruency TKA design.
Secondary ID [1] 301916 0
Nil known
Universal Trial Number (UTN)
U1111-1256-2636
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
knee osteoarthritis 318458 0
Condition category
Condition code
Surgery 316464 316464 0 0
Other surgery
Musculoskeletal 316827 316827 0 0
Osteoarthritis

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
This project will recruit patients receiving a total knee arthroplasty (TKA) at Fremantle Hospital who have already been determined by their treating surgeon as receiving one of two commonly used knee implant systems; TriathlonTM or AttuneTM. These implants are used for straightforward knee osteoarthritis, and the selection is based upon surgeon preference. Currently the participating surgeons in the department are split, with approximately 50% of surgeons preferring the TriathlonTM implants, and 50% preferring the AttuneTM implants. Participation in this study will not affect which implant patients receive, nor will it affect any aspect of their surgical treatment.

The AttuneTM implant system is a highly congruent design, and TKA with this implant takes approximately 90 minutes.

The clinical pathway for patients who participate in the study will differ only minimally from standard practice for TKA patients, in that they will undergo an additional objective assessment of their knee stability in the sagittal plane (forwards and backwards) with a device called a GNRB arthrometre. Examination with this device involves strapping the knee into the arthrometre, where 134N of pressure is applied to the top of the shin bone while the end of the thigh bone is held steady. The amount of backwards movement of the knee is measured objectively. This will occur with the knee in 20 degrees of flexion. 3 readings will be taken so that the average can be calculated. This examination will take approximately 10 minutes. Studies using this device have allowed participants to withdraw at any time if they find the examination uncomfortable, and no participants have elected to withdraw in these studies. This will occur preoperatively and at 6 weeks and 12 months follow up.

Additionally, participants will be asked to complete patient reported outcome surveys preoperatively and at 6 weeks and 12 months follow up.

Completion of 12 month follow up will conclude the participants commitment to the study.
Intervention code [1] 318218 0
Not applicable
Comparator / control treatment
The TriathlonTM is a comparatively less congruent TKA implant design. TKA using this implant takes approximately 90 minutes.
Control group
Active

Outcomes
Primary outcome [1] 324613 0
Objective sagittal stability of the knee measured using GNRB arthrometre reading, recorded in mm of displacement.

<5mm will be considered stable, 6-10mm partially unstable and >10mm unstable.
Timepoint [1] 324613 0
Preoperatively at booking consult, then 6 weeks and 12 months post operatively
Secondary outcome [1] 385213 0
Participant perception of function, stability, satisfaction, confidence and motion using the Patient knee implant performance (PKIP) score; a 9 question patient reported outcome measure. This is a composite outcome.
Timepoint [1] 385213 0
Preoperatively at booking consult, then 6 weeks and 12 months post operatively
Secondary outcome [2] 385214 0
Knee range of movement (flexion and extension), measured using a goniometer, and recorded in degrees.
Timepoint [2] 385214 0
Preoperatively at booking consult, then 6 weeks and 12 months post operatively
Secondary outcome [3] 385215 0
Clinical assessment of sagittal stability of the knee using Lachman's test and anterior draw.

Lachman's will be recorded in grades, where grade I indicates 3-5mm translation, grade II indicates 5-10mm translation and grade III indicates >10mm translation.

Anterior draw will be recorded as positive or negative, where positive is a lack of a firm end point, or increased laxity compared with the contralateral side.
Timepoint [3] 385215 0
Preoperatively at booking consult, then 6 weeks and 12 months post operatively
Secondary outcome [4] 386275 0
Participant perception of quality of life, function, pain, stiffness and other symptoms assessed using the Knee Injury and Osteoarthritis Outcome Score; a 6 domain patient reported outcome measure survey. This is a composite outcome.
Timepoint [4] 386275 0
Preoperatively at booking consult, then 6 weeks and 12 months post operatively
Secondary outcome [5] 386276 0
Participant perception of pain, function, mobility and stability assessed using the Oxford Knee Score; a 12 question patient reported outcome measure. This is a composite outcome.
Timepoint [5] 386276 0
Preoperatively at booking consult, then 6 weeks and 12 months post operatively
Secondary outcome [6] 386277 0
Participant perception of overall health and quality of life using the Short Form 12 (SF-12); a 12 question patient reported outcome measure survey. This is a composite outcome.
Timepoint [6] 386277 0
Preoperatively at booking consult, then 6 weeks and 12 months post operatively

Eligibility
Key inclusion criteria
Patients over 18 years of age who are booked for primary TKA to treat osteoarthritis at Fremantle Hospital, and consent to study participation.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients:
• Who have anatomy unsuitable for an Attune or Triathlon implant
• With Rheumatoid Arthritis
• Who are unable to provide consent, and/or unable to complete the satisfaction surveys
• Who are pregnant

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Convenience sample
Timing
Prospective
Statistical methods / analysis
Categorical variables will be analysed using Chi-square test, whilst continuous variables will be analysed with an independent samples t-test using SPSS (IBM Pty Ltd). Interim analysis is not intended to be performed.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
30/11/2020
Actual
Date of last participant enrolment
Anticipated
28/05/2021
Actual
Date of last data collection
Anticipated
28/07/2023
Actual
Sample size
Target
80
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 17182 0
Fremantle Hospital and Health Service - Fremantle
Recruitment postcode(s) [1] 30885 0
6160 - Fremantle

Funding & Sponsors
Funding source category [1] 306329 0
Commercial sector/Industry
Name [1] 306329 0
Johnson & Johnson
Country [1] 306329 0
Australia
Primary sponsor type
Individual
Name
Associate Professor Chris Jones
Address
Fremantle Hospital Department of Orthopaedic Surgery
Level 6 B Block
Alma St
FREMANTLE 6160
Country
Australia
Secondary sponsor category [1] 307118 0
Hospital
Name [1] 307118 0
Department of Orthopaedic Surgery
Address [1] 307118 0
Fremantle Hospital
Alma St
FREMANTLE WA 6160
Country [1] 307118 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306540 0
South Metropolitan Health Service Human Research Ethics Committee
Ethics committee address [1] 306540 0
14 Barry Marshall Parade
MURDOCH WA 6150
Ethics committee country [1] 306540 0
Australia
Date submitted for ethics approval [1] 306540 0
30/06/2020
Approval date [1] 306540 0
07/08/2020
Ethics approval number [1] 306540 0
RGS0000003876

Summary
Brief summary
This is a prospective double-blind cross-sectional cohort study, assessing the difference in knee stability in the sagittal (forwards and backwards) between two commonly used implants, and the effect that this has on patient satisfaction.

Patients with a primary diagnosis of knee osteoarthritis who are over 18 years of age and are booked for a TKA at Fremantle Hospital receiving either an AttuneTM or TriathlonTM primary knee replacement will be recruited. Patients will be recruited at their booking visit, and consenting participants will be asked to complete validated Patient Reported Outcome Measure (PROM) questionnaires. Sagittal stability will be objectively measured by a device called a GNRB arthrometer at 30 degrees and 90 degrees of knee flexion. 134N of force will be applied to the top of the shin bone whilst the thigh bone is held steady and anterior displacement of the tibia will be measured. Clinical evaluation of stability will occur through physical examination. Sagittal stability is defined according to the amount anterior translation of the tibia with <5mm deemed stable, 6-10mm partially unstable and >10mm unstable. Range of movement in flexion and extension will be assessed with a goniometer and recorded. Radiological assessment prior to their surgery will be routine as per all joint replacements; pre-operative alignment and post-operative alignment will be assessed with long-leg alignment views. Each surgeon involved will use only 1 prosthesis type for all participating patients under their care (TriathlonTM or AttuneTM) in line with current practice.

Participants and the examiner performing assessment of sagittal stability will be blinded to implant type. All implant details (size, side, patella, polyethylene type, polyethylene thickness and patella resurfacing) will be explicitly recorded and tracked. Patients are randomly assigned to each surgeon according to the participating hospital's outpatient referral system, as is current practice. Pre-operative demographic analysis of patient characteristics will be used to screen for selection bias. TKA will be performed as per the surgeon’s preferred technique according to the manufacturer’s recommendations. Plain radiographs, PROMs and assessment of sagittal stability will be repeated at 6 weeks and 12 months follow up.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 104218 0
A/Prof Christopher Jones
Address 104218 0
Department of Orthopaedic Surgery
Fremantle Hospital
Alma Street
FREMANTLE WA 6160
Country 104218 0
Australia
Phone 104218 0
+61 417220248
Fax 104218 0
Email 104218 0
[email protected]
Contact person for public queries
Name 104219 0
Dr Heidi Wilson
Address 104219 0
Department of Orthopaedic Surgery
Fremantle Hospital
Alma Street
FREMANTLE WA 6160
Country 104219 0
Australia
Phone 104219 0
+61 8 94313333
Fax 104219 0
Email 104219 0
[email protected]
Contact person for scientific queries
Name 104220 0
Dr Heidi Wilson
Address 104220 0
Department of Orthopaedic Surgery
Fremantle Hospital
Alma Street
FREMANTLE WA 6160
Country 104220 0
Australia
Phone 104220 0
+61 8 94313333
Fax 104220 0
Email 104220 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
This study will be blinded, therefore individual data is not able to be made available.


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.