The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12619001024134
Ethics application status
Approved
Date submitted
3/07/2019
Date registered
17/07/2019
Date last updated
17/07/2019
Date data sharing statement initially provided
17/07/2019
Date results information initially provided
17/07/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Cementless Versus Cemented Tibial Fixation in Posterior Stabilised Total Knee Replacement - a Randomised Trial
Scientific title
Cementless Versus Cemented Tibial Fixation in Posterior Stabilised Total Knee Replacement - a Randomised Trial
Secondary ID [1] 298636 0
NONE
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
knee arthroplasty 313508 0
implant fixation 313509 0
osteoarthritis 313510 0
Condition category
Condition code
Surgery 311943 311943 0 0
Surgical techniques
Musculoskeletal 312006 312006 0 0
Osteoarthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants underwent Total Knee Replacement surgery, with all variables standardised except tibial component fixation, where one group was cemented and one cementless. Procedure duration was about 60 minutes of surgical time per case.
The implants were monitored for migration, bone mineral density and subjective clinical scores including Oxford Knee Score, Short From 12 and pain scores. Physical materials used include Advanced Coated System Total Knee Replacement implants in cemented and cementless tibial models.
Two experienced arthroplasty surgeons carried out the operations, all were done at Hollywood Private Hospital. Followup was conducted at 3, 12 and 24 months post surgery
Intervention code [1] 314899 0
Treatment: Surgery
Comparator / control treatment
Patients were randomised to cemented (control) or cementless tibial fixation; other variables were standardised
Control group
Active

Outcomes
Primary outcome [1] 320601 0
implant migration as determined by radiostereometric analysis
Timepoint [1] 320601 0
3, 12 and 24 (primary timepoint) months post-operative
Secondary outcome [1] 372173 0
bone mineral density as determined by dual-energy x-ray absorptiometry
Timepoint [1] 372173 0
3, 12 and 24 months post-operative
Secondary outcome [2] 372174 0
oxford knee score
Timepoint [2] 372174 0
3, 12 and 24 months post-operative
Secondary outcome [3] 372326 0
short form 12 score
Timepoint [3] 372326 0
3, 12 and 24 months post-operative
Secondary outcome [4] 372327 0
pain as determined by visual analogue scale score
Timepoint [4] 372327 0
3, 12 and 24 months post-operative

Eligibility
Key inclusion criteria
diagnosis of osteoarthritis in the knee, requiring knee replacement
Minimum age
50 Years
Maximum age
90 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
valgus alignment
osteoporosis
osteopenia
prior ipsilateral knee surgery
patients taking bisphosphonates, corticosteroids or cytostatic agents

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)
Although the operating surgical team and the radiologists could not be blinded to implant fixation method, patients, hospital staff and data collectors were blinded to allocation.
Allocation was performed by computer-based central randomisation
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The random allocation sequence was generated by a randomisation web site using the method of randomly permuted blocks (www.randomization.com).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
Intervention assignment
Parallel
Other design features
This single-centre prospective, parallel blinded randomised clinical trial, enrolled 100 TKR cases over 22 months with follow-up to 24 months. All patients were operated on by one of two experienced arthroplasty surgeons and randomised to fixation in 1:1 ratio.
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Baseline characteristics of the two groups were compared using independent samples t-tests for continuous variables and a chi-square test for gender.
Normality was examined by the Shapiro-Wilk test. Following logarithmic transformation, these variable distributions were no longer significantly skewed from normality and allowed for statistical analysis. Independent-samples t-tests were used to compare conditions at 3, 12 and 24 months. All reported analyses have an alpha level of 0.05.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 14132 0
Hollywood Private Hospital - Nedlands
Recruitment postcode(s) [1] 26944 0
6009 - Nedlands

Funding & Sponsors
Funding source category [1] 303176 0
Commercial sector/Industry
Name [1] 303176 0
THE JOINT STUDIO
Address [1] 303176 0
Hollywood Medical Centre, 85 Monash Avenue, Nedlands, WA 6009
Country [1] 303176 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
THE JOINT STUDIO
Address
Hollywood Medical Centre, 85 Monash Avenue, Nedlands, WA 6009
Country
Australia
Secondary sponsor category [1] 303311 0
None
Name [1] 303311 0
Address [1] 303311 0
Country [1] 303311 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303738 0
Hollywood Private Hospital Research Ethics Committee
Ethics committee address [1] 303738 0
Hollywood Private Hospital, Monash Avenue, Nedlands, WA 6009
Ethics committee country [1] 303738 0
Australia
Date submitted for ethics approval [1] 303738 0
30/10/2012
Approval date [1] 303738 0
21/01/2013
Ethics approval number [1] 303738 0
HPH352

Summary
Brief summary

This randomised study compared how tibial fixation affected component migration, bone remodelling and clinical outcomes in Posterior Stabilised Total Knee Replacements. 100 patients were randomised to receive TKRs with cemented or cementless tibial components. The hypothesis was that tibial fixation method would impact implant stability.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 94626 0
Dr NILS OSCAR NIVBRANT
Address 94626 0
The Joint Studio, Hollywood Medical Centre, 85 Monash Avenue, Nedlands, WA 6009,
Country 94626 0
Australia
Phone 94626 0
+61 433 501123
Fax 94626 0
Email 94626 0
nilsnivbrant@gmail.com
Contact person for public queries
Name 94627 0
Dr NILS OSCAR NIVBRANT
Address 94627 0
The Joint Studio, Hollywood Medical Centre, 85 Monash Avenue, Nedlands, WA 6009,
Country 94627 0
Australia
Phone 94627 0
+61 433 501123
Fax 94627 0
Email 94627 0
nilsnivbrant@gmail.com
Contact person for scientific queries
Name 94628 0
Dr NILS OSCAR NIVBRANT
Address 94628 0
The Joint Studio, Hollywood Medical Centre, 85 Monash Avenue, Nedlands, WA 6009,
Country 94628 0
Australia
Phone 94628 0
+61 433 501123
Fax 94628 0
Email 94628 0
nilsnivbrant@gmail.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Participant migration, bone density and clinical score data will be available on request
When will data be available (start and end dates)?
Immediately following publication, no end date
Available to whom?
systematic reviewers, journal peer reviewers
Available for what types of analyses?
to achieve the aims in the approved proposal
How or where can data be obtained?
access subject to approvals by Principal Investigator, enquiries to nilsnivbrant@gmail.com
What supporting documents are/will be available?
No other documents available
Summary results
Have study results been published in a peer-reviewed journal?
No
Other publications
Have study results been made publicly available in another format?
No
Results – plain English summary
Late and continuing migration was shown with cementless fixation. At 24 months mean subsidence was significantly greater for the cementless group.
The cemented group had a greater degree of bone mineral density loss than the cementless group in the medial, lateral and anterior periprosthetic regions.
Two tibial components were revised, both cementless.
Clinical scores improved equally between groups.