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Trial registered on ANZCTR


Registration number
ACTRN12616000758404
Ethics application status
Approved
Date submitted
25/05/2016
Date registered
9/06/2016
Date last updated
4/06/2019
Date data sharing statement initially provided
4/06/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Evaluation of the Functional Outcomes Following a Saiph Total Knee Replacement and Reproducibility of Outcomes of Procedures performed by the General Surgeon Population compared with the Design Surgeon Team Procedures .
Scientific title
Evaluation of Functional Outcomes Following Saiph Total Knee Replacement and Reproducibility of Design Surgeon Team Procedures by the General Surgeon Population.
Secondary ID [1] 289287 0
None
Universal Trial Number (UTN)
U1111-1183-1642
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Knee Replacement 298875 0
Condition category
Condition code
Musculoskeletal 298944 298944 0 0
Osteoarthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients will be consented to be included into the study. The patient will undergo total knee replacement surgery and receive a Saiph Total Knee Replacement which is a cemented implant that evolved from the successful Freeman-Samuelson principles. The operation will take approximately 1.5 hours and will be performed by the consultant orthopaedic surgeon with experience of implanting the Saiph Knee. The Saiph Knee is a TGA approved product and is used by many orthopaedic surgeons in Australia and New Zealand.



Intervention code [1] 294839 0
Treatment: Devices
Comparator / control treatment
The results will be compared to patient outcomes of the Saiph Knee when performed by the surgeon design team performed from November 2011 to December 2014. The control data was obtained in a clinical study, and the results will be published prior to the end of the current study. This study was performed under ethics approval at St Vincent's Hospital Sydney (Trial No 12/254) and The Avenue Hospital Melbourne (Trial No 144).
Control group
Historical

Outcomes
Primary outcome [1] 298414 0
Clinical outcomes using the Oxford Knee Score
Timepoint [1] 298414 0
Assessed pre-operatively and post-operatively at 6 months or 1 year, 2 years and 5 years.
Primary outcome [2] 298495 0
Implant survivorship based on revision of primary components. The data will be analysed using the Kaplan Meier Survival Analysis.

Timepoint [2] 298495 0
Assessed at 2 years and 5 years post-operatively.
Secondary outcome [1] 324068 0
Clinical outcomes using KOOS
Timepoint [1] 324068 0
Assessed pre-operatively and post-operatively at 6 months or 1 year, 2 years and 5 years.
Secondary outcome [2] 324375 0
Clinical outcomes using EQ-5D
Timepoint [2] 324375 0
Assessed pre-operatively and post-operatively at 6 months or 1 year, 2 years and 5 years.
Secondary outcome [3] 324376 0
Clinical outcomes using the UCLA Activity Score
Timepoint [3] 324376 0
Assessed pre-operatively and post-operatively at 6 months or 1 year, 2 years and 5 years.
Secondary outcome [4] 324551 0
X-Ray Analysis to assess implant position and alignment.
Timepoint [4] 324551 0
Assessed pre-operatively, immediately post-operatively and at 6 weeks, 6 months or 1 year, 2 years and 5 years.

Eligibility
Key inclusion criteria
1. Patients requiring a primary knee replacement as determined jointly by the surgeon and the patient
2. Over 18 years of age at time of surgery
3. Patients who understand the conditions of the study and are willing to participate for the length of the prescribed term of follow-up
4. Patients who are capable of, and have given, informed consent to their participation in the study
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Pregnant females or those planning on becoming pregnant during follow-up period
2. Patients with no pre-operative data and questionnaires
3. Patients with active local or systemic infection, severe osteoporosis or severe neurological, vascular or muscular compromise such that knee replacement is inappropriate.
4. Patients with severe bone loss or collateral ligament instability
5. Workers compensation patients

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/efficacy
Statistical methods / analysis
There are no comparators in the primary end point for this particular study therefore no formal calculation is necessary.
The data will be will be summarised and a Kaplan Meier Survival analysis will be performed using revision as the event definition.

Recruitment
Recruitment status
Recruiting
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)
NSW,SA,WA,VIC
Recruitment hospital [1] 7999 0
Warringal Private Hospital - Heidelberg
Recruitment hospital [2] 8000 0
St John of God Hospital, Murdoch - Murdoch
Recruitment hospital [3] 8001 0
Mater Sydney - North Sydney
Recruitment hospital [4] 8002 0
Westmead Private Hospital - Westmead
Recruitment hospital [5] 8003 0
Southern Highlands Private Hospital - Bowral
Recruitment hospital [6] 8004 0
Calvary Wakefield Hospital - Adelaide
Recruitment hospital [7] 8005 0
Calvary Private Hospital - Wagga Wagga
Recruitment hospital [8] 8006 0
Albury-Wodonga Private Hospital - Albury
Recruitment hospital [9] 8007 0
Albury Wodonga Health - Albury campus - Albury
Recruitment hospital [10] 8008 0
Royal Melbourne Hospital - City campus - Parkville
Recruitment hospital [11] 8009 0
St Vincents & Mercy Private Hospital - Mercy campus - East Melbourne
Recruitment hospital [12] 11226 0
Lingard Private Hospital - Merewether
Recruitment hospital [13] 11227 0
Melbourne Private Hospital - Parkville
Recruitment hospital [14] 13912 0
Fremantle Hospital and Health Service - Fremantle
Recruitment postcode(s) [1] 15981 0
2060 - North Sydney
Recruitment postcode(s) [2] 15982 0
2145 - Westmead
Recruitment postcode(s) [3] 23099 0
2291 - Merewether
Recruitment postcode(s) [4] 15983 0
2576 - Bowral
Recruitment postcode(s) [5] 15986 0
2640 - Albury
Recruitment postcode(s) [6] 15985 0
2650 - Wagga Wagga
Recruitment postcode(s) [7] 15988 0
3002 - East Melbourne
Recruitment postcode(s) [8] 15987 0
3050 - Parkville
Recruitment postcode(s) [9] 23100 0
3052 - Parkville
Recruitment postcode(s) [10] 15979 0
3084 - Heidelberg
Recruitment postcode(s) [11] 15984 0
5000 - Adelaide
Recruitment postcode(s) [12] 15980 0
6150 - Murdoch
Recruitment postcode(s) [13] 26683 0
6160 - Fremantle
Recruitment outside Australia
Country [1] 7895 0
New Zealand
State/province [1] 7895 0
Whangarei

Funding & Sponsors
Funding source category [1] 293664 0
Commercial sector/Industry
Name [1] 293664 0
MatOrtho Limited
Address [1] 293664 0
PO Box 7455
Warringah Mall
NSW 2100
Country [1] 293664 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
MatOrtho Limited
Address
PO Box 7455
Warringah Mall
NSW 2100
Country
Australia
Secondary sponsor category [1] 292498 0
None
Name [1] 292498 0
Address [1] 292498 0
Country [1] 292498 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295102 0
St Vincent's Hospital Melbourne HREC
Ethics committee address [1] 295102 0
41 Victoria Parade
Fitzroy
VIC 3065
Ethics committee country [1] 295102 0
Australia
Date submitted for ethics approval [1] 295102 0
22/09/2015
Approval date [1] 295102 0
17/11/2015
Ethics approval number [1] 295102 0
HREC-D 151/15
Ethics committee name [2] 295117 0
The Avenue Hospital HREC
Ethics committee address [2] 295117 0
40 The Avenue
WINDSOR VIC 3181
Ethics committee country [2] 295117 0
Australia
Date submitted for ethics approval [2] 295117 0
20/09/2015
Approval date [2] 295117 0
11/11/2015
Ethics approval number [2] 295117 0
Trial 194
Ethics committee name [3] 295118 0
Northland District Health Board
Ethics committee address [3] 295118 0
Whangarei Hospital
Maunu Road, Private Bag 9742, Whangarei, 0148
Ethics committee country [3] 295118 0
New Zealand
Date submitted for ethics approval [3] 295118 0
20/09/2015
Approval date [3] 295118 0
28/10/2015
Ethics approval number [3] 295118 0
2015-29
Ethics committee name [4] 297669 0
St. Vincent’s Health and Aged Care Human Research and Ethics Committee
Ethics committee address [4] 297669 0
627 Rode Road, Chermside QLD 4032
Ethics committee country [4] 297669 0
Australia
Date submitted for ethics approval [4] 297669 0
10/04/2017
Approval date [4] 297669 0
30/05/2017
Ethics approval number [4] 297669 0
17/04

Summary
Brief summary
This is a prospective, international multi-centre clinical study. The study will enrol a minimum of 1000 patients over a 36 month recruitment period between approximately 25 surgeons at 30 centres in Australia and New Zealand.
The objectives of the study are:
* To evaluate the clinical outcomes of the Saiph Total Knee Replacement and ensure that it performs as intended.
* To compare the results of this study to the optimal clinical results of the design surgeons to ensure their results can be reproduced.

The Saiph Total Knee Replacement (TKR) is intended for use as a primary total knee replacement device consisting of a femoral, tibial, tibial bearing and optional patellar component. The Saiph TKR is CE marked, TGA approved and has a rebate code on the Prostheses List.

Clinical evaluations: Standard, functional parameters such as range of motion will be assessed preoperatively, and postoperatively at 6 weeks and at 6/12 months. Further clinical evaluations at 2 years and 5 years will be collected only for those patients that return to clinic for this review.

Patient outcome assessments: The KOOS (Full Version), Oxford Knee Score (OKS), EQ5D and UCLA Activity Scale will be assessed preoperatively, and postoperatively at 6/12 months, 2 years and 5 years.

Radiographic evaluations: Anterior and lateral X-rays will be analysed preoperatively, immediately postoperatively and at standard of care time points thereafter.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 66138 0
Mr Jonathan Bare
Address 66138 0
Melbourne Orthopaedic Group
33 The Avenue, Windsor
VIC 3181
Country 66138 0
Australia
Phone 66138 0
+61 3 9525 0837
Fax 66138 0
+61 3 9521 2037
Email 66138 0
jbare@mog.com.au
Contact person for public queries
Name 66139 0
Ms Helen Hunter
Address 66139 0
MatOrtho Limited
Unit 224
Level 2, T1
14 Lexington Drive
Norwest Business Park
BELLA VISTA
NSW 2153
Country 66139 0
Australia
Phone 66139 0
+61 2 8824 3509
Fax 66139 0
+61 2 8814 7423
Email 66139 0
HelenHunter@matortho.com.au
Contact person for scientific queries
Name 66140 0
Dr Jenny Burke
Address 66140 0
NeoSurgical Pty Ltd
Unit 2, 41-43
Green Street
Botany, NSW 2019
Country 66140 0
Australia
Phone 66140 0
+61 488 240471
Fax 66140 0
Email 66140 0
jennyburke@neosurgical.com.au

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 other documents available
Summary results
No Results