Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12606000325505
Ethics application status
Approved
Date submitted
20/07/2006
Date registered
31/07/2006
Date last updated
21/06/2024
Date data sharing statement initially provided
21/06/2024
Date results information initially provided
21/06/2024
Type of registration
Retrospectively registered

Titles & IDs
Public title
Clinical Outcomes of Increased Flexion Total Knee Replacement.
Scientific title
A randomised controlled trial to evaluate knee range of motion (ROM), pain and functional outcomes of patients after primary total knee arthroplasty (TKA) for knee osteoarthritis with the Increased Flexion Profix Total Knee System (Smith & Nephew, Inc.).
Secondary ID [1] 253359 0
Dr Simon Journeaux
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Osteoarthritis of the knee 1295 0
Condition category
Condition code
Musculoskeletal 1385 1385 0 0
Osteoarthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Total knee arthroplasty with the Profix Total Knee System (Smith & Nephew, Inc). This system enables the surgeon to implant the femoral prosthesis in a 4 degree flexed position (increased flexion technique) or in a neutral position (standard technique)
Intervention code [1] 1217 0
None
Comparator / control treatment
No comparator.
Control group
Active

Outcomes
Primary outcome [1] 1889 0
Range of motion of the knee: flexion
Knee flexion will be assessed using computer analysis of a digital photograph of the knee in maximum passive knee flexion.
Timepoint [1] 1889 0
Pre-operatively, intra-operatively and post-operatively at 6 weeks, 6 months, one year
Secondary outcome [1] 3333 0
Function, strength, quality of life.
Timepoint [1] 3333 0
Pre-operatively and post-operatively at 6 weeks, 6 months, one and two years.

Eligibility
Key inclusion criteria
Adults listed for total knee replacement at the Mater Adult Hospital, with a diagnosis of non-inflammatory degenerative joint disease, who will be available for follow-up evaluations for 2 years.
Minimum age
18 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Active local or systemic infection, patients undergoing revision knee or complex primary arthroplasty, patients who are to have bilateral knee arthroplasty or those who have had knee arthroplasty in the previous 12 months. Pre-existing severe osteoporosis, or any other systemic or metabolic disorders causing progressive deterioration of bone.

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)
Randomisation concealed in opaque envelopes and provided to surgeon. Details of surgical technique (increased flexion or standard instrumentation) sealed in opaque envelope within medical chart.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation will follow a computer generated blocked randomisation sequence. The size of the blocks is not variable and was determined independently to maintain blinding of assessors. Allocation was stratified according to pre-operative range of knee motion.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
13/06/2006
Actual
13/06/2006
Date of last participant enrolment
Anticipated
Actual
31/12/2008
Date of last data collection
Anticipated
Actual
31/12/2008
Sample size
Target
40
Accrual to date
Final
40
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 1519 0
Commercial sector/Industry
Name [1] 1519 0
Smith & Nephew
Country [1] 1519 0
Australia
Primary sponsor type
Government body
Name
Mater Health Services
Address
Raymond Terrace, South Brisbane, Queensland, 4101
Country
Australia
Secondary sponsor category [1] 1334 0
University
Name [1] 1334 0
University of Queensland, School of Health & Rehabilitation Sciences.
Address [1] 1334 0
St Lucia
Country [1] 1334 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2943 0
Mater Misericordiae Ltd Human Research Ethics Committee
Ethics committee address [1] 2943 0
http://www.materresearch.org.au/about-us/human-research-ethics-and-governance/human-research-ethics
Ethics committee country [1] 2943 0
Australia
Date submitted for ethics approval [1] 2943 0
Approval date [1] 2943 0
16/11/2005
Ethics approval number [1] 2943 0
910A
Ethics committee name [2] 2944 0
The University of Queensland Human Research Ethics Committee A
Ethics committee address [2] 2944 0
https://www.uq.edu.au/research/research-support/ethics-integrity-and-compliance/human-ethics
Ethics committee country [2] 2944 0
Australia
Date submitted for ethics approval [2] 2944 0
Approval date [2] 2944 0
08/03/2006
Ethics approval number [2] 2944 0
2006000159

Summary
Brief summary
Total knee arthroplasty (TKA) is a common, successful and safe operation for people who have end-stage knee arthritis. Pain-free knee flexion or bend of 135 degrees or more with stability is the goal of TKA. There are substantial improvements in pain and function. However, a major problem that persists is that patients do not consistently achieve knee flexion or bend greater than 110 degrees.
The need to improve surgical technique and prosthetic designs to provide better flexibility and function is therefore essential. Many designs are available and currently in use. This study involves the use of one of these designs; the Profix Total Knee System (Smith & Nephew, Inc.). This system gives the surgeon the option to implant the prosthesis onto the leg using either increased flexion or standard instruments. The instruments are used by the surgeon to ensure accurate placement of the prosthesis.
The objective of this study is to compare knee flexion range of motion (ROM), pain and functional outcomes of patients after primary TKA with the Profix Total Knee System.

The primary hypothesis is that patients who have Profix TKA’s implanted by the surgeon with increased flexion instruments will achieve significantly greater knee flexion than those implanted with standard instruments.
The secondary hypothesis is that this increased knee flexion will allow improved functional ability with less pain and as a result better quality of life.
The trial is a double blind study with patients, assessors and data analysts blinded to group allocation
Trial website
Trial related presentations / publications
Murphy MT, Journeaux SF, Hides JA, Russell TG. Does flexion of the femoral implant in total knee arthroplasty increase knee flexion: a randomised controlled trial. Knee 2014;21(1):257-63
Public notes

Contacts
Principal investigator
Name 35553 0
Dr Michael Murphy
Address 35553 0
Mater Hospital Brisbane
Raymond Terrace
South Brisbane
Country 35553 0
Australia
Phone 35553 0
+61 403477718
Fax 35553 0
Email 35553 0
[email protected]
Contact person for public queries
Name 10406 0
Michael Murphy
Address 10406 0
Department of Orthopaedics
Mater Health Services
South Brisbane QLD 4101
Country 10406 0
Australia
Phone 10406 0
+61 7 38408787
Fax 10406 0
+61 7 38408877
Email 10406 0
[email protected]
Contact person for scientific queries
Name 1334 0
Michael Murphy
Address 1334 0
Department of Orthopaedics
Mater Health Services
South Brisbane QLD 4101
Country 1334 0
Australia
Phone 1334 0
+61 7 38408787
Fax 1334 0
+61 7 38408877
Email 1334 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.