Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618000441213
Ethics application status
Approved
Date submitted
20/03/2018
Date registered
27/03/2018
Date last updated
27/03/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
A multicentre, post-marketing, prospective, observational study to evaluate the safety and performance of the Apex Total Knee Replacement system.
Scientific title
A multicentre, post-marketing, prospective, observational study to evaluate the safety and performance of the Apex Total Knee Replacement system.
Secondary ID [1] 293845 0
Study Protocol Number: APEX KNEE 2017-01
Universal Trial Number (UTN)
U1111-1208-2543
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Total Knee Arthroplasty 306303 0
Osteoarthritis 306304 0
Condition category
Condition code
Musculoskeletal 305385 305385 0 0
Osteoarthritis

Intervention/exposure
Study type
Observational
Patient registry
True
Target follow-up duration
10
Target follow-up type
Years
Description of intervention(s) / exposure
This study is a post-market, prospective study to monitor and evaluate the intended performance and ongoing safety of the Apex Knee System manufactured by Omni Life Science and Global Orthopaedic Technology following a primary total knee arthroplasty.

It follows the investigators standard practice for a total knee arthroplasty. The surgical duration will be the same as for a routine total knee arthroplasty surgery. All participants will be clinically assessed using standard functional parameters measuring range of movement pre-operatively, three months post-operatively, 1 year, and 2 years.
Intervention code [1] 300378 0
Not applicable
Comparator / control treatment
No control group.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 304858 0
Range of motion
Measured in the clinic using standard goniometer .
Timepoint [1] 304858 0
Preoperative (within 4 weeks of surgery), and post-operatively at 3 months, 1 year, 2 years [primary timepoint], measured at 5 year and 10 years for those that attend clinic (optional)
Secondary outcome [1] 343386 0
Quality of life assessed by EQ5D-5L
Timepoint [1] 343386 0
Preoperative (within 4 weeks of surgery), and at 3 months, 1 year, 2 years, 5 years, and 10 years post-operative.
Secondary outcome [2] 344651 0
Patient Reported Outcome measured using the Oxford Knee Score
Timepoint [2] 344651 0
Preoperative (within 4 weeks of surgery), and at 3 months, 1 year, 2 years, 5 years, and 10 years post-operative.
Secondary outcome [3] 344652 0
Patient Reported Outcome measured using the Forgotten Joint Score
Timepoint [3] 344652 0
At 3 months, 1 year, 2 years, 5 years, and 10 years post-operative.

Eligibility
Key inclusion criteria
1. Be over 18 years old
2. Be capable of understanding the study requirements and of providing informed consent
3. Be eligible for a primary total knee replacement based on history, physical examination, and radiological evaluation
4. Agree to attend the research centre for the required post-operative assessments and radiological evaluation
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Women who are pregnant or breast feeding or plan to become pregnant during the course of the study
2. Not willing or unable to return for required follow-up visits or clear demonstration or likely poor compliance
3. Any medical condition including current infections that in the judgement of the investigator would prohibit compliance with routine surgical follow-up
5. The individual has a neuromuscular or neurosensory deficiency that limits the ability to evaluate the safety and effectiveness of the device
6. Previous patellectomy
7. Previous proximal tibial or distal femur osteotomy
8. Extra-articular deformity
9. The individual does not speak, read, or comprehend the English language

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/04/2018
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
1000
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC

Funding & Sponsors
Funding source category [1] 298740 0
Commercial sector/Industry
Name [1] 298740 0
Global Orthopaedic Technology
Country [1] 298740 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Global Orthopaedic Technology
Address
Unit 10/7 Meridian Pl, Bella Vista NSW, 2153, Australia
Country
Australia
Secondary sponsor category [1] 297912 0
None
Name [1] 297912 0
Address [1] 297912 0
Country [1] 297912 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299679 0
Bellberry Human Research Ethics Committee (HREC)
Ethics committee address [1] 299679 0
129 Glen Osmond Rd, Eastwood, SA 5063
Ethics committee country [1] 299679 0
Australia
Date submitted for ethics approval [1] 299679 0
29/11/2017
Approval date [1] 299679 0
19/12/2017
Ethics approval number [1] 299679 0
2017-11-851

Summary
Brief summary
The safety and performance of the Apex Total Knee Replacement system manufactured by Omni Life Science and Global Orthopaedic Technology will be evaluated following primary total knee arthroplasty.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 68102 0
Mr Neil Bergman
Address 68102 0
Suite 10, Warringal Medical Centre,
214 Burgundy St, Heidelberg, VIC 3084
Country 68102 0
Australia
Phone 68102 0
+61 3 9457 5100
Fax 68102 0
Email 68102 0
[email protected]
Contact person for public queries
Name 68103 0
Mr Lyndon Crossley
Address 68103 0
Global Orthopaedic Technology Unit 10, 7 Meridian Place, Baulkham Hills, NSW 2153
Country 68103 0
Australia
Phone 68103 0
+61 2 8887 0100
Fax 68103 0
Email 68103 0
[email protected]
Contact person for scientific queries
Name 68104 0
Mr Lyndon Crossley
Address 68104 0
Global Orthopaedic Technology Unit 10, 7 Meridian Place, Baulkham Hills, NSW 2153
Country 68104 0
Australia
Phone 68104 0
+61 2 8887 0100
Fax 68104 0
Email 68104 0
[email protected]

No information has been provided regarding IPD availability


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.