Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617001277336
Ethics application status
Approved
Date submitted
31/07/2017
Date registered
6/09/2017
Date last updated
6/09/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
A study to compare the accuracy of acetabular and femoral component position and orientation in total hip arthroplasty (THA) using three different techniques : conventional freehand methods, Corin Optimised Positioning System (OPS)™ and the Intellijoint Hip® infrared navigation system.
Scientific title
Accuracy of assistive technologies for acetabular cup and femoral stem positioning: A randomised controlled trial in primary total hip arthroplasty
Secondary ID [1] 292555 0
CT-2017-CTN-01652-1 v1.
Clinical Trial Notification Acknowledged by TGA
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
osteoarthritis, 304222 0
Condition category
Condition code
Surgery 303574 303574 0 0
Surgical techniques
Musculoskeletal 303587 303587 0 0
Osteoarthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Primary total hip arthroplasty (THA), or hip replacement surgery, is predominantly an elective procedure for the treatment of osteoarthritis (OA) in the hip. THA involves insertion of one implant into the head of the femur (long leg bone; femoral component) and one into the pelvis (acetabular component) to achieve a ball and cup design to replace the diseased hip. The angle with which the femoral implant and the acetabular implant are inserted into the bone during surgery dictate how well the ball and socket fit together. The target angles for the implants to achieve the ‘best fit’are typically determined prior to surgery using radiographic images. During surgery, the surgeon will aim to achieve the preplanned
target values for implant placement. Optimal orientation of both implants during surgery
improves patient’s limb function, satisfaction and the overall survivorship of the implants. Traditionally surgeons have used unassisted, freehand methods to place the implants into a predetermined ‘safe zone’ that is guided by bony landmarks on the pelvis and femur. More recently, assistive technologies have emerged that utilise laser technology or navigational technology to improve positioning of implants to match the preplanned target values.
The primary aim of this project is to compare the accuracy of three techniques currently available for positioning of the acetabular and femoral implant components during THA:
Group 1: Conventional, unassisted (freehand) methods
Group 2: Corin Optimised Positioning System (OPS)™ using patientspecific,
imagederived instrumentation and laserassisted positioning technology (IDI+LAT)
Group 3: Intellijoint Hip® infrared navigation system only
We hypothesise that the technique used for intraoperative positioning of the acetabular cup and femoral components will make no difference to the accuracy in executing preoperatively defined targets. We will test our hypothesis by performing a single site, multisurgeon, prospective randomised controlled trial in patients undergoing
unilateral and bilateral THA for advanced osteoarthritis (OA).

1)Recruitment
Potential participants who meet the selection criteria will be approached in clinic by the investigating surgeons ( Dr Kaushik Hazratwala and Dr Matthew Wilkinson D are qualified orthopaedic surgeons) and provided information on the study, with an opportunity to ask questions. Willing participants will be asked to provide consent for participation.

2)Consent
Each investigator will provide information to the patient of the purpose of the study and what their participation would involve in terms of the type and frequency of assessments throughout the study. The investigators will discuss foreseeable risks involved and potential benefits arising from the completing the study. Each potential participant will be provided an information sheet and invited to discuss taking part in the study with others. Patients will be informed by the investigator that they are free to refuse participation in the study, or to withdraw from the study at any time, without compromising their medical care. Patients will be informed that confidentiality of personal data will be maintained at all times and access to this information will be restricted to authorised personnel only.
3)Pre-Surgery
All patients who consent to be enrolled in the study are scheduled for radiographic assessment and standard protocols utilised for the Corin OPS™ 3D planning component will be applied to the current study and performed preoperatively for all study participants.In addition to this, participation in this study
requires the completion of four questionnaires (Western Ontario and McMaster Universities Arthritis Index WOMAC, Hip Disability and Osteoarthritis Outcome Score HOOS Jnr, EuroQuol 5 dimensions EQ5D, FJS Forgotten Joint Score). The same four questionnaires will be completed postoperatively.
4)Surgical Procedure
THA will be performed according to standard protocols used by the Investigating orthopaedic surgeon. A posterior-lateral approach will be used for all study participants. The recommended surgical techniques for placement of the Trinity™ Advanced Bearing Acetabular System and the MetaFix™ or TriFit TS™ femoral stem will be used, where appropriate. The only difference between study participants will be the technique used to facilitate accurate positioning the femoral and acetabular implants; the intent being to achieve a position that is as close as possible to the preoperatively determined target values.
The recommended surgical protocol for the Corin OPS™ IDI+LAP component will be used to assist acetabular and femoral stem placement for study participants in Group 2. The Intellijoint Hip® navigation system will be used according to manufacturer’ surgical protocols to assist acetabular and femoral stem positioning for study participants in Group 3.
5)Study Outcomes
The following standard parameters will be assessed on pre- and postoperative radiographs of participants in the current study
Date of radiograph/Date of assessment
Acetabular inclination
Acetabular anteversion
Acetabular cup radiographic findings (loosening/migration)
Femoral stem version
Leg length
Horizontal centre of rotation
Vertical centre of rotation
Preoperatively determined implant sizing and actual implant sizing used
Subluxation
Loosening
Cysts
Fractures
Intervention code [1] 298763 0
Treatment: Surgery
Intervention code [2] 298773 0
Treatment: Devices
Comparator / control treatment
The control group for this study (Group 1 from Description of intervention exposure Section) is based on conventional methods that do not utilise assistive technology for implant delivery during THA.
Control group
Active

Outcomes
Primary outcome [1] 302929 0
Accuracy of acetabular component positioning for each of the three execution techniques.

The accuracy of acetabular component positioning (Corin Trinity™ acetabular system) for each of the three execution techniques will be determined by comparison of the deviation of anteversion and inclination angles among the preoperative plan, intraoperative records (Group 3 only – Intellijoint Hip®) and data from post-operative CT at 6 weeks.
Timepoint [1] 302929 0
6 weeks Post-Operative
Primary outcome [2] 302930 0
Accuracy of femoral component positioning for each of the three execution techniques

The accuracy of femoral stem (Metafix™ or Trifit TS™) positioning for each of the three execution techniques will be determined by comparison of the deviation of leg length, offset and version between the preoperative plan, intraoperative records (Group 3 only – Intellijoint Hip®) and data from post-operative CT.
Timepoint [2] 302930 0
6 weeks
Secondary outcome [1] 337469 0
Correlation between predicted and actual implant sizes used

Differences between the planned prostheses size and the size implanted in the acetabulum and femur will be determined to assess the percentage reliability in preoperative templating using the Corin OPS™ planning component for all study participants.
In other words the Preoperative planning using the Corin OPS™ is compared with actual usage.
Timepoint [1] 337469 0
Intraoperative
Secondary outcome [2] 337472 0
Comparison of operative time
Skin to skin operative time is routinely recorded for all THA performed by both surgeons at the study site. This information will be used to determine whether the use of the three execution techniques to be evaluated in the current study, effect the overall length of time for the surgical procedure.
Timepoint [2] 337472 0
intraoperative
Secondary outcome [3] 337473 0
Comparison of complications (composite secondary outcome )
Intraoperative and postoperative complication rates will be determined for each of the three execution techniques.
The occurrence of any of the following intraoperative complications will be recorded:
acetabular fractures
femoral fractures
sciatic nerve injury
anaesthetic complications
excessive blood loss (indicated by day one post-operative haemoglobin levels)

Intraoperative blood loss will be compared between groups statistical analysis will be performed for reporting purposes. However, the clinical application of excessive blood loss will be assessed by the treating surgeon. If intraoperative loss of more than 100mls will be considered excessive not necessarily clinically important or indicate requirement for transfusion. Hemoglobin and hematocrit will be obtained and transfusion will be given on the basis of symptomatic anemia with hemoglobin of <7.0g/dL.
Timepoint [3] 337473 0
intraoperative and day one post-operative
Secondary outcome [4] 337474 0
Patient reported outcome measures (PROM) scores:
WOMAC (Western Ontario McMaster Universities Osteoarthritis)
Timepoint [4] 337474 0
6 weeks post-operative and 1,2,5,10 years postoperative
Secondary outcome [5] 337513 0
Patient Reported Outcome Measure (PROM)scores:
HOOS (Hip Disability and Osteoarthritis Outcome Score) Junior Hip Surgery
Timepoint [5] 337513 0
6 weeks post-operative and 1,2,5,10 years post operative
Secondary outcome [6] 337514 0
Patient Reported Outcome Measure (PROM)scores:
EQ5D Score
Timepoint [6] 337514 0
6 weeks post-operative and 1,2,5,10 years post operative
Secondary outcome [7] 337515 0
Patient Reported Outcome Measure (PROM)scores

FJS (Forgotten Joint Score)
Timepoint [7] 337515 0
6 weeks post-operative and 1,2,5,10 years post operative
Secondary outcome [8] 338058 0
The time to discharge
Timepoint [8] 338058 0
Date of admission and Date of discharge
Secondary outcome [9] 338059 0
Time to mobilize.
Time to mobilize is defined by the patient's ability to ambulate on the operated limb, assisted by physical therapist
Timepoint [9] 338059 0
Measured in days; same day is considered day 0, day 1 is next day following surgery
Secondary outcome [10] 338060 0
Postoperative Comparison of complication (composite secondary outcome )
The occurrence of any of the following postoperative complications will be recorded:
infection
deep vein thrombosis
falls
return to theatre
dislocation
Participants will be actively followed up for clinic review at the indicated time points. Immediate postoperative complications include those which occur within the hospital admission stay and under the management of the operating surgeon. Following discharge, participants will e reviewed at scheduled post op time points for review. Patients experiencing a fall, pain high, temperatures, discomfort or signs of infection are counselled on this by their pre-surgical admission procedure and report the incidence to their care team. The research coordinator has ethics permission to review the databank which records this information and access to the medical records postoperative to cross check these events.
Timepoint [10] 338060 0
immediate post-operative, 6 weeks post-operative and 1,2,5,10 years post operative

Eligibility
Key inclusion criteria
Patients scheduled to undergo primary total hip arthroplasty
Male and female
Age 40-90
Able to provide informed consent
Patients that will receive a cementless Corin femoral stem (Metafix™ or Trifit TS™) with a Trinity™ Advanced Bearing Acetabular system (surgeon choice)Patients with BMI <40
Minimum age
40 Years
Maximum age
90 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients with significant orthopaedic deformities, anatomical disruption/distortion of pelvis
Previous open surgical procedure to hip
Patients unable to comply with assessment requirements
Patients with active infection
Patients with BMI >40, where ability to carry out the operative technique using the navigation system may be compromised
Patients who are pregnant or planning on becoming pregnant during the course of the study
Patients unable to provide informed consent

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
18/09/2017
Actual
Date of last participant enrolment
Anticipated
18/09/2019
Actual
Date of last data collection
Anticipated
18/09/2029
Actual
Sample size
Target
150
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 8664 0
Mater Hospital Pimlico - Pimlico
Recruitment postcode(s) [1] 16775 0
4812 - Pimlico
Recruitment postcode(s) [2] 16776 0
4810 - Pimlico

Funding & Sponsors
Funding source category [1] 297133 0
Commercial sector/Industry
Name [1] 297133 0
Corin (Australia) Pty Ltd
Country [1] 297133 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Corin (Australia) Pty Ltd
Address
17 Bridge Street,
Pymble
NSW 2073
Australia
Country
Australia
Secondary sponsor category [1] 296150 0
None
Name [1] 296150 0
Address [1] 296150 0
Country [1] 296150 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298303 0
Mater Health Services North Queensland Ltd Human Research Ethics Committee (EC00412)
Ethics committee address [1] 298303 0
Ethics committee country [1] 298303 0
Australia
Date submitted for ethics approval [1] 298303 0
Approval date [1] 298303 0
18/05/2017
Ethics approval number [1] 298303 0
MHS20170509-01

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 76650 0
Dr Kaushik Hazratwala
Address 76650 0
Mater Medical Centre
Suite 101, Level 2
21-37 Fulham Rd,
Pimlico QLD 4812
Country 76650 0
Australia
Phone 76650 0
+61 7 4727 4111
Fax 76650 0
Email 76650 0
[email protected]
Contact person for public queries
Name 76651 0
Andrea Grant
Address 76651 0
The Orthopaedic Research Institute of Queensland (ORIQL)
7 Turner St, Pimlico
QLD 4812, Australia.
Country 76651 0
Australia
Phone 76651 0
+61 7 4755 0564
Fax 76651 0
Email 76651 0
[email protected]
Contact person for scientific queries
Name 76652 0
Andrea Grant
Address 76652 0
The Orthopaedic Research Institute of Queensland (ORIQL)
7 Turner St, Pimlico
QLD 4812, Australia.
Country 76652 0
Australia
Phone 76652 0
+61 7 4755 0564
Fax 76652 0
Email 76652 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

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