Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000157673
Ethics application status
Approved
Date submitted
2/02/2023
Date registered
16/02/2023
Date last updated
16/02/2023
Date data sharing statement initially provided
16/02/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Functional and self-reported outcomes of primary total knee arthroplasty in osteoarthritis comparing two variations of the B.Braun prosthesis used in standard care
Scientific title
Primary hinged total knee arthroplasty (TKA) in severe osteoarthritis: A prospective study
of survival, patient function and satisfaction compared with unconstrained TKA
Secondary ID [1] 308892 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Osteoarthritis 328885 0
Condition category
Condition code
Surgery 325880 325880 0 0
Surgical techniques
Musculoskeletal 325964 325964 0 0
Osteoarthritis

Intervention/exposure
Study type
Observational
Patient registry
True
Target follow-up duration
12
Target follow-up type
Months
Description of intervention(s) / exposure
This study has been designed to utilise a currently operating standard care system of functional and patient-reported data collection in order to compare patient reported outcome measures and satisfaction scores of patients 60 years and over at the time of surgery, receiving a B.Braun Enduro hinged knee prosthesis for osteoarthritis, to age-matched controls receiving a primary conventional B.Braun Columbus unconstrained prosthesis.

Furthermore, to determine early functional outcomes of patients receiving a hinged knee prosthesis at day 3, day 14 and 6 weeks post-operative; medium-term patient-reported outcomes at 6 and 12 months post-operative; complication, survival and revision rates following use of the hinged knee prosthesis at 12 months post-operative.

This current standard practice of patient-reported outcome measure data collection from each patient may take approximately 20 minutes to complete from a home computer at each interval. Functional measurements completed by physiotherapists occur as part of standard treatment and progress visits. None of these measures occur in addition to standard care or require an additional time commitment than any other Joint Replacement Clinic patient.
Intervention code [1] 325338 0
Not applicable
Comparator / control treatment
The standard care prosthesis will serve as the comparator group for this study; the B.Braun Columbus unhinged prosthesis.
Control group
Active

Outcomes
Primary outcome [1] 333717 0
To compare patient functional outcomes using the Oxford Knee Score (OKS) at 6 weeks post-operative in the hinged TKA group, as compared to SC.

These questionnaires are completed by all patients via a secure electronic database as per standard care.
Timepoint [1] 333717 0
6 weeks post-operative.
Secondary outcome [1] 418042 0
To determine early recovery outcomes of patients receiving a hinged knee prosthesis including timed-up-and-go (TUG).

This data is collected by physiotherapists at routine follow-up visits.
Timepoint [1] 418042 0
Day 3 and day 14 post-operative.
Secondary outcome [2] 418043 0
To assess patient reported outcome measures (PROMs) including the Oxford Knee Score (OKS).

These questionnaires are completed by all patients via a secure electronic database as per standard care.
Timepoint [2] 418043 0
6 and 12 months post-operative.
Secondary outcome [3] 418044 0
To assess patient reported outcome measures (PROMs) including the Knee Osteoarthritis Outcome Score 12-item (KOOS-12).

These questionnaires are completed by all patients via a secure electronic database as per standard care.
Timepoint [3] 418044 0
6 weeks, 6 and 12 months post-operative.
Secondary outcome [4] 418045 0
To assess patient reported outcome measures (PROMs) including the Euroqol 5 Dimensional Health Survey Level 5 (EQ5D5L).

These questionnaires are completed by all patients via a secure electronic database as per standard care.
Timepoint [4] 418045 0
6 weeks, 6 and 12 months postoperative.
Secondary outcome [5] 418372 0
To determine early recovery outcomes of patients receiving a hinged knee prosthesis including length of stay (LOS).

This data is collected by physiotherapists at routine follow-up visits.
Timepoint [5] 418372 0
Day 3 (or alternate hospital discharge day).
Secondary outcome [6] 418373 0
To determine early recovery outcomes of patients receiving a hinged knee prosthesis including range of movement (ROM).

This data is collected by physiotherapists at routine follow-up visits.
Timepoint [6] 418373 0
Day 3 and day 14 post-operative.
Secondary outcome [7] 418377 0
To assess patient-reported outcome measures (PROMs) including the Single Assessment Numeric Evaluation (SANE) of 'normal'.

These questionnaires are completed by all patients via a secure electronic database as per standard care.
Timepoint [7] 418377 0
6 weeks, 6 and 12 months post-operative.
Secondary outcome [8] 418378 0
To assess patient-reported outcome measures including the Visual Analogue Scale (VAS) for pain.

These questionnaires are completed by all patients via a secure electronic database as per standard care.
Timepoint [8] 418378 0
6 weeks, 6 and 12 months post-operative.
Secondary outcome [9] 418379 0
To assess patient revision rates post-operative.

Patients are created and monitored in our electronic database as both primary or revision surgeries. Data will be exported at the conclusion of the study to determine revision rates. In the case of patients who receive a revision surgery at an alternative clinic, the surgeon is notified by the treating surgeon and this is maintained in patient records.
Timepoint [9] 418379 0
12 months post-operative.
Secondary outcome [10] 418380 0
To assess patient complication rates post-operative.

This data is routinely collected and maintained by the JRC clinical co-ordinator and patient liaison who is made aware of any patient complications by either hospital staff or patient files when seeing patients on the ward, or patients themselves. On occasion, the administrative staff are made aware, in which case the JRC clinical co-ordinator and patient liaison is made aware. This is routinely recorded within the clinic patient files and subsequently entered into the electronic database. Standard clinical complications may include; DVT, wound concerns, falls, infection, fracture or 'other'.
Timepoint [10] 418380 0
12 months post-operative.

Eligibility
Key inclusion criteria
1. Patients 60 years and over receiving a primary HTKA prosthesis for advanced OA of the knee (Kellgren-Lawrence grade IV).
2. Patients 60 years and over receiving a primary TKA conventional unconstrained prosthesis for advanced OA of the knee (Kellgren-Lawrence grade IV).
Minimum age
60 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Patients receiving a hinged TKA for revision knee surgery.
2. Patients receiving a hinged TKA for Rheumatoid arthritis, neuromuscular disorders or pathologies other than Osteoarthritis.
3. Patients under 60 years of age at the time of surgery.

Study design
Purpose
Screening
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
The study arm (HTKA) will be compared against the control arm (SC) for all analyses. Non-inferiority will be claimed if the lower 95% confidence limit of the mean difference between HTKA and SC is less than the minimally clinical important difference (MCID) of -5 after adjusting for key potential confounders (pre-operative OKS, age, BMI and gender).
Other continuous secondary outcomes will be analysed in a similar manner, that is, using multiple linear regression with terms for group (HTKA vs SC), pre-operative score, age, gender and BMI.
Survival and revision will be examined using Kaplan-Meier curves and Cox regression with terms for group, age, gender and BMI. Complications will be described using frequency and percentages at 12 months.
Two subgroups will be examined;
• Patients with valgus deformity
• Patients with varus deformity

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
28/02/2023
Actual
Date of last participant enrolment
Anticipated
29/02/2024
Actual
Date of last data collection
Anticipated
28/02/2025
Actual
Sample size
Target
132
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA

Funding & Sponsors
Funding source category [1] 313104 0
Commercial sector/Industry
Name [1] 313104 0
B.Braun Australia
Country [1] 313104 0
Australia
Primary sponsor type
Other
Name
The Joint Replacement Clinic
Address
151 Hutt St, Adelaide SA 5000
Country
Australia
Secondary sponsor category [1] 314803 0
None
Name [1] 314803 0
nil
Address [1] 314803 0
nil
Country [1] 314803 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312353 0
Bellberry Pty Ltd
Ethics committee address [1] 312353 0
Ethics committee country [1] 312353 0
Australia
Date submitted for ethics approval [1] 312353 0
06/12/2022
Approval date [1] 312353 0
25/01/2023
Ethics approval number [1] 312353 0
2022-11-1253

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

Contacts
Principal investigator
Name 124350 0
Dr Sunil Reddy
Address 124350 0
The Joint Replacement Clinic,
151 Hutt Street Adelaide SA 5000
Country 124350 0
Australia
Phone 124350 0
+61451051291
Fax 124350 0
Email 124350 0
[email protected]
Contact person for public queries
Name 124351 0
Shehara Silva
Address 124351 0
The Joint Replacement Clinic,
151 Hutt Street Adelaide SA 5000
Country 124351 0
Australia
Phone 124351 0
+61 08 8232 8889
Fax 124351 0
Email 124351 0
[email protected]
Contact person for scientific queries
Name 124352 0
Kristen Georgiou
Address 124352 0
The International Musculoskeletal Research Institute (IMRI)
13 Laffers Road Belair SA 5052
Country 124352 0
Australia
Phone 124352 0
+61 08 8232 8889
Fax 124352 0
Email 124352 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?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
18214Ethical approval    385323-(Uploaded-02-02-2023-13-50-28)-Study-related document.pdf



Results publications and other study-related documents

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