Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622001299796
Ethics application status
Approved
Date submitted
8/09/2021
Date registered
7/10/2022
Date last updated
7/10/2022
Date data sharing statement initially provided
7/10/2022
Date results information initially provided
7/10/2022
Type of registration
Retrospectively registered

Titles & IDs
Public title
Safe Tibial Subsidence Pattern of a Medial Pivot Knee. A Radiostereometric Analysis (RSA) Study
Scientific title
Safe Tibial Subsidence Pattern of a Medial Pivot Knee Arthroplasty for Osteoarthritis. An RSA Study
Secondary ID [1] 305261 0
None
Universal Trial Number (UTN)
U1111-1269-3201
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
osteoarthritis 323534 0
arthroplasty 323535 0
Condition category
Condition code
Musculoskeletal 321099 321099 0 0
Osteoarthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
All patients underwent total knee arthroplasty with the Saiph implant system from Matortho, each surgery taking an estimated one hour. Follow up X-rays were performed at six weeks postoperative and at one and two years, each time taking approximately twenty minutes.
Intervention code [1] 321650 0
Treatment: Surgery
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 328877 0
Radiostereometric analysis to assess component migration
Timepoint [1] 328877 0
24 months post surgery
Secondary outcome [1] 400753 0
Implant survival assessed by potential revision surgery
Timepoint [1] 400753 0
24 months post surgery

Eligibility
Key inclusion criteria
osteoarthritis
Minimum age
18 Years
Maximum age
99 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Planned or actual pregnancy, prior ipsilateral arthroplasty surgery, diagnosed osteoporosis or osteopenia and medications associated with it such as bisphosphonates, corticosteroids and Protos

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
2/04/2014
Date of last participant enrolment
Anticipated
Actual
1/03/2019
Date of last data collection
Anticipated
Actual
1/03/2020
Sample size
Target
35
Accrual to date
Final
35
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 20489 0
Fremantle Hospital and Health Service - Fremantle
Recruitment postcode(s) [1] 35261 0
6160 - Fremantle

Funding & Sponsors
Funding source category [1] 309630 0
Commercial sector/Industry
Name [1] 309630 0
Matortho
Country [1] 309630 0
Australia
Primary sponsor type
Hospital
Name
Fremantle Hospital and Health Service
Address
1/3 Alma St, Fremantle WA 6160
Country
Australia
Secondary sponsor category [1] 310650 0
None
Name [1] 310650 0
Address [1] 310650 0
Country [1] 310650 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309405 0
South Metro Health Service Human Research Ethics Committee WA
Ethics committee address [1] 309405 0
14 Barry Marshall Parade, MURDOCH WA 6150
Ethics committee country [1] 309405 0
Australia
Date submitted for ethics approval [1] 309405 0
05/02/2013
Approval date [1] 309405 0
26/02/2013
Ethics approval number [1] 309405 0
13/3

Summary
Brief summary
BACKGROUND
Micromotion analysis supports effective cemented tibial component fixation in Total Knee Replacement (TKR) but a paucity of literature exists for medial pivot designs. This clinical study examined the tibial component micromotion and clinical scores in a second-generation medial pivot TKR.

METHODS
This prospective single-center clinical cohort trial involved 35 patients with a mean patient age of 71 years. Operations were performed by one experienced arthroplasty surgeon using the SAIPH implant (MatOrtho). All patients received fully cemented fixation with patella resurfacing. Other variables were standardized. Radiostereometric Analysis was performed at 6 weeks and 12 months to monitor tibial component behavior.

The working hypothesis of this study is that the SAIPH tibial baseplate achieves stable fixation using bone cement in subjects undergoing TKR

Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 114042 0
Prof Piers Yates
Address 114042 0
Fremantle Hospital and Health Service, Alma St, Fremantle WA 6160
Country 114042 0
Australia
Phone 114042 0
+61418594392
Fax 114042 0
Email 114042 0
piersyates@hotmail.com
Contact person for public queries
Name 114043 0
Prof Piers Yates
Address 114043 0
Fremantle Hospital and Health Service, Alma St, Fremantle WA 6160
Country 114043 0
Australia
Phone 114043 0
+610894313333
Fax 114043 0
Email 114043 0
piersyates@hotmail.com
Contact person for scientific queries
Name 114044 0
Dr Nils Oscar Nivbrant
Address 114044 0
Fremantle Hospital and Health Service, Alma St, Fremantle WA 6160
Country 114044 0
Australia
Phone 114044 0
+610433501123
Fax 114044 0
Email 114044 0
nilsnivbrant@gmail.com

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.