Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620000992909
Ethics application status
Approved
Date submitted
10/07/2020
Date registered
2/10/2020
Date last updated
2/10/2020
Date data sharing statement initially provided
2/10/2020
Type of registration
Retrospectively registered

Titles & IDs
Public title
Modern Surgical Approaches in total hip replacement: A prospective pilot study including gait analysis
Scientific title
Modern Surgical Approaches in Total Hip Replacement (THR): A prospective pilot study including gait analysis comparing anterior, superior and posterior hip approaches in total hip arthroplasty.
Secondary ID [1] 301740 0
Nil known
Universal Trial Number (UTN)
U1111-1255-0881
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hip Osteoarthritis 318200 0
Condition category
Condition code
Musculoskeletal 316207 316207 0 0
Osteoarthritis
Surgery 316695 316695 0 0
Surgical techniques

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Total hip arthroplasty approaches will be compared.
Arm 1 - Anterior approach
Arm 2 - Superior approach
Arm 3 - Posterior approach

Patients will not be randomised. 10 consecutive posterior approaches will be performed by each surgeon and 10 consecutive superior OR anterior approaches will be performed depending on the surgeons experience.

The approximate surgical time is similar for all three approaches 60-120 mins.
Each surgeon will have completed appropriate training in the anterior or superior approach provided by Medacta and Stryker respectively.
Each approach will be provided by qualified Orthopaedic Surgeons familiar with the approaches based at Counties Manukau District Health Board and Waitemata District Health Board.

The patient records will be used to monitor the fidelity of the intervention.
Intervention code [1] 318038 0
Treatment: Surgery
Comparator / control treatment
Posterior approach will be the control group. In New Zealand it is the most common approach used for THR and on average takes 60-90 minutes to be performed.
Control group
Active

Outcomes
Primary outcome [1] 324392 0
Gait analysis - 12-camera VICON system with Bertec force plates and IMeasureU inertial sensing units.

Composite Outcome - full 3D kinematic and kinetic analysis, so the outcome measures include:
- double support time, walk ratio, variability of step velocity, and single support asymmetry.
- hip, knee, ankle joint angles and joint moments (peak values, ROM, and integrated values)
- The inertial sensors will give us an impact loading measurement (we call it a bone stimulus metric) and a measure of asymmetry
Timepoint [1] 324392 0
Base line pre operative, 1 month postoperative (primary timepoint), 2 months postoperative
Primary outcome [2] 324393 0
Physiotherapy outcomes - supine straight leg raise
Timepoint [2] 324393 0
Base line pre operative, 1 month postoperative (primary timepoint), 2 months postoperative
Primary outcome [3] 324394 0
Radiographic outcomes - acetabular inclination (well aligned 35-50 degrees),
Timepoint [3] 324394 0
Immediate post operative Xray
Secondary outcome [1] 384537 0
Patient reported outcome scores - modified harris hip score,
Timepoint [1] 384537 0
Base line pre operative, 1 month postoperative , 2 months postoperative
Secondary outcome [2] 385864 0
Radiographic outcomes - femoral stem alignment (well aligned 3 degrees varus/valgus),
Timepoint [2] 385864 0
Immediate post operative Xray
Secondary outcome [3] 385866 0
Radiographic outcomes - leg length difference to contralateral side
Timepoint [3] 385866 0
Immediate post operative Xray
Secondary outcome [4] 385867 0
Radiographic outcomes - leg length difference to contralateral side
Timepoint [4] 385867 0
Immediate post operative Xray
Secondary outcome [5] 385869 0
Radiographic outcomes - restoration of femoral offset compared to contralateral side.
Timepoint [5] 385869 0
Immediate post operative Xray
Secondary outcome [6] 385870 0
Patient reported outcome scores - hip osteoarthritis outcome score
Timepoint [6] 385870 0
Base line pre operative, 1 month postoperative, 2 months postoperative
Secondary outcome [7] 385871 0
Patient reported outcome scores - visual analog pain scale
Timepoint [7] 385871 0
Base line pre operative, 1 month postoperative, 2 months postoperative
Secondary outcome [8] 385872 0
Patient reported outcome scores - quality of recovery 15
Timepoint [8] 385872 0
Base line pre operative, 1 month postoperative 2 months postoperative
Secondary outcome [9] 385873 0
Physiotherapy outcomes - TUG test,
Timepoint [9] 385873 0
Baseline preop, Post op prior to discharge post operative 1 month
Secondary outcome [10] 385874 0
Physiotherapy outcomes - walking with/without aids, - this will be assessed by asking the patient at each time point whether they can mobilise with or without aids.
Timepoint [10] 385874 0
Base line pre operative, post op prior to discharge 1 month postoperative, 2 months postoperative
Secondary outcome [11] 385875 0
Physiotherapy outcomes - stairs with/without aids

this will be assessed by asking the patient at each time point whether they can mobilise with or without aids
Timepoint [11] 385875 0
primary timepoint 1 month postoperative, 2 months postoperative
Secondary outcome [12] 385876 0
Physiotherapy outcomes - ability to walk 1 km

this will be assessed by asking the patient at each time point whether they can mobilise with or without aids
Timepoint [12] 385876 0
primary timepoint 1 month postoperative, 2 months postoperative

Eligibility
Key inclusion criteria
Patients 35- 65 years with unilateral symptomatic OA of hip joint
Charnley class A
Minimum age
35 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Lower limb deformities including post traumatic or congenital.
Previous surgery

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
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
27/07/2020
Date of last participant enrolment
Anticipated
31/03/2021
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
90
Accrual to date
2
Final
Recruitment outside Australia
Country [1] 22731 0
New Zealand
State/province [1] 22731 0
Auckland

Funding & Sponsors
Funding source category [1] 306174 0
Commercial sector/Industry
Name [1] 306174 0
Stryker New Zealand
Country [1] 306174 0
New Zealand
Funding source category [2] 306175 0
Commercial sector/Industry
Name [2] 306175 0
Medacta NZ of Pioneer Medical
Country [2] 306175 0
New Zealand
Primary sponsor type
Hospital
Name
Counties Manukau DHB
Address
100 Hospital Road
Otahuhu
Auckland 2025
Country
New Zealand
Secondary sponsor category [1] 306646 0
University
Name [1] 306646 0
University of Auckland Bioengineering Insititute
Address [1] 306646 0
UniServices House, Level, 6/70 Symonds Street, Grafton, Auckland 1010
Country [1] 306646 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306388 0
Northern B Health and Disability Ethics Committee.
Ethics committee address [1] 306388 0
Ministry of Health
Health and Disability Ethics Committees
PO Box 5013
Wellington 6140
Ethics committee country [1] 306388 0
New Zealand
Date submitted for ethics approval [1] 306388 0
Approval date [1] 306388 0
25/02/2020
Ethics approval number [1] 306388 0
20/NTB/2

Summary
Brief summary
The primary purpose of the study is to show whether there is any difference in the patient outcomes, radiographic outcomes and gait of patients treated with total hip arthroplasty for osteoarthritis. We will compare the anterior, posterior and superior approaches.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 103706 0
Prof Rocco Pitto
Address 103706 0
Counties Manukau District Health Board
100 Hospital Road
Otahuhu
Auckland 2025
Country 103706 0
New Zealand
Phone 103706 0
+64 21542130
Fax 103706 0
Email 103706 0
[email protected]
Contact person for public queries
Name 103707 0
Dr Timothy Godwin
Address 103707 0
Counties Manukau District Health Board
100 Hospital Road
Otahuhu
Auckland 2025
Country 103707 0
New Zealand
Phone 103707 0
+64 21 142 1627
Fax 103707 0
Email 103707 0
[email protected]
Contact person for scientific queries
Name 103708 0
Prof Rocco Pitto
Address 103708 0
Counties Manukau District Health Board
100 Hospital Road
Otahuhu
Auckland 2025
Country 103708 0
New Zealand
Phone 103708 0
+64 21542130
Fax 103708 0
Email 103708 0
[email protected]

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.