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Trial registered on ANZCTR


Registration number
ACTRN12618001011279p
Ethics application status
Submitted, not yet approved
Date submitted
18/05/2018
Date registered
15/06/2018
Date last updated
15/06/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Accuracy of patient specific instrumentation for implant position for patients undergoing reverse total shoulder arthroplasty.
Scientific title
Accuracy of patient-specific, image derived instrumentation in glenoid prosthesis positioning: A randomised, controlled trial in reverse total shoulder arthroplasty (RTSA).
Secondary ID [1] 292828 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Osteoarthritis of the Shoulder 304666 0
Condition category
Condition code
Surgery 303982 303982 0 0
Surgical techniques
Musculoskeletal 307229 307229 0 0
Osteoarthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Use of patient-specific, image-derived instrumentation for glenoid prosthesis positioning in reverse total shoulder arthroplasty. Custom, 3D-printed jigs are produced from Computed Tomography (CT) imaging of the participant's affected shoulder, through digital planning technology (Materialise NV). Patient undergoes a CT, Materialise produce a planned template for the implant positioning for which the surgeon approves. Jigs are manufactured through 3D printing and provided for the day of surgery. These jigs are then used intra-operatively by consultant surgeons to aid proper positioning of the component. Participants are recruited from those undergoing shoulder arthroplasty under the care of the investigating surgeons. Verification of implant positioning will be performed by the patient undergoing a Postoperative CT at 6 weeks after surgery.
Intervention code [1] 299078 0
Treatment: Surgery
Comparator / control treatment
Control treatment is the use of standard instrumentation routinely used by orthopaedic surgeons for positioning the glenoid prosthesis.
Standard Instrumentation is not individually manufactured according to the patients anatomy.
Control group
Active

Outcomes
Primary outcome [1] 303318 0
Accuracy of placement of glenoid positioning will be assessed by comparing the version, inclination and translation measured on post-operartive CT with the pre-operative plans.

Timepoint [1] 303318 0
6 weeks post-op
Secondary outcome [1] 338621 0
Functional outcomes will be assessed using Oxford Shoulder Score, Veterans RAND 12 Item Health Survey (VR-12 ) and Constant Shoulder Score
Timepoint [1] 338621 0
6 months post-op

Eligibility
Key inclusion criteria
- Scheduled for reverse total shoulder replacement for primary arthritis of the shoulder joint, with radiographic evidence of the need for arthroplasty.
- Able to provide informed consent
- BMI <40
Minimum age
40 Years
Maximum age
90 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Unable to comply with assessment requirements
- Unable to provide informed consent
- Pregnant, or planning to become pregnant within the duration of the study period.
- BMI >40
- Active infection
- Significant other orthopaedic deformities, anatomical disruption/distortion of the shoulder joint other than that caused by OA.
- Undergoing RTSA for management of proximal humerus fracture.

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)
Allocation not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computerised sequence generator
Permuted block randomisation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Power analysis was conducted utilising the results of prior, similar studies. Type 1 error of 0.05 & Type II error of 0.2 would require 22 participants in each of the two study arms (intervention + comparator) to observe correlation. To allow for an estimated 10% loss to follow-up, 25 patients will be recruited to each arm, giving a total number of 50 participants.
Statistical analysis will be carried out using SPSS software.

Recruitment
Recruitment status
Not yet 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)
QLD
Recruitment hospital [1] 8965 0
Mater Hospital Pimlico - Pimlico
Recruitment hospital [2] 8966 0
The Townsville Hospital - Douglas
Recruitment postcode(s) [1] 17338 0
4810 - Pimlico
Recruitment postcode(s) [2] 17339 0
4814 - Douglas

Funding & Sponsors
Funding source category [1] 297459 0
Charities/Societies/Foundations
Name [1] 297459 0
The Orthopaedic Research Institute of Queensland (ORIQL)
Address [1] 297459 0
7 Turner Street
Pimlico, QLD 4812
Country [1] 297459 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
The Orthopaedic Research Institute of Queensland (ORIQL)
Address
7 Turner Street
Pimlico, QLD 4812
Country
Australia
Secondary sponsor category [1] 296458 0
Commercial sector/Industry
Name [1] 296458 0
LIMA Orthopaedics Australia Pty Ltd
Address [1] 296458 0
1/40 Ricketts Rd
Mount Waverley
VIC, 3149
Country [1] 296458 0
Australia

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 298564 0
Townsville Hospital Health Services Human Research & Ethics Committee
Ethics committee address [1] 298564 0
Townsville Hospital and Health Service
100 Angus Smith Drive
Douglas, QLD, 4814
Ethics committee country [1] 298564 0
Australia
Date submitted for ethics approval [1] 298564 0
21/05/2018
Approval date [1] 298564 0
Ethics approval number [1] 298564 0

Summary
Brief summary
The aim of this study is to compare the accuracy of the glenoid placement with use of patient specific, image-derived instrumentation to that of standard instrumentation in reverse total shoulder arthroplasty.
There will be two study groups: Group 1 (n=25), Conventional surgical technique (without guides)
Group 2 (n=25), Patient specific, use of image derived instrumentation guides.
The null hypothesis for this study is that the use of patient specific guides for the glenoid component positioning will make no difference in the accuracy of component placement.
A total of 50 patients will be recruited for the study.
Sites for the study include Townsville Hospital and Health Services and Mater Health Services North Queensland Ltd.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 77486 0
Dr Levi Morse
Address 77486 0
Dr Levi Morse Orthopaedic Rooms
57 Park Street, Pimlico
QLD, 4812
Country 77486 0
Australia
Phone 77486 0
+61 7 4409 2090
Fax 77486 0
Email 77486 0
levimorse@yahoo.com
Contact person for public queries
Name 77487 0
Mrs Andrea Grant
Address 77487 0
Orthopaedic Research Institute of Queensland
ORIQL House
7 Turner Street, Pimlico
QLD, 4812
Country 77487 0
Australia
Phone 77487 0
+61 7 4755 0564
Fax 77487 0
Email 77487 0
research_coordinator@oriql.com.au
Contact person for scientific queries
Name 77488 0
Mrs Andrea Grant
Address 77488 0
Orthopaedic Research Institute of Queensland
ORIQL House
7 Turner Street, Pimlico
QLD, 4812
Country 77488 0
Australia
Phone 77488 0
+61 7 4755 0564
Fax 77488 0
Email 77488 0
research_coordinator@oriql.com.au

No data has been provided for results reporting
Summary results
Not applicable