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Trial registered on ANZCTR


Registration number
ACTRN12616000696493
Ethics application status
Approved
Date submitted
3/05/2016
Date registered
26/05/2016
Date last updated
6/09/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
The STEP study: A Pragmatic, randomized, controlled trial comparing two post operative management pathways in knee or hip replacement surgery
Scientific title
The STEP study: A Pragmatic, randomized, controlled trial comparing two post operative management pathways in knee or hip replacement surgery
Secondary ID [1] 288361 0
None
Universal Trial Number (UTN)
Trial acronym
STEP
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hip Total Joint Arthroplasty 297360 0
Knee Total Joint Arthroplasty 297361 0
Condition category
Condition code
Musculoskeletal 297548 297548 0 0
Osteoarthritis
Physical Medicine / Rehabilitation 298905 298905 0 0
Physiotherapy
Surgery 298906 298906 0 0
Other surgery

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
First Arm: Post-Operative Management according to one pathway which facilitates patient recovery after total joint arthroplasty (TJA) through a mixture of pre surgical teaching and post surgical physiotherapy. It will involve heath professionals including orthopedics surgeons, nurses, physiotherapists and occupational therapists. Specific details have been omitted to preserve study blinding; these have been provided to the ANZCTR staff (via the Private notes) and will be published here once the trial has been completed.

Intervention code [1] 293667 0
Treatment: Other
Intervention code [2] 293668 0
Rehabilitation
Comparator / control treatment
Second Arm: Post-Operative Management according to a second pathway which facilitates patient recovery after total joint arthroplasty (TJA) through a mixture of pre surgical teaching and post surgical physiotherapy. It will involve heath professionals including orthopedics surgeons, nurses, physiotherapists and occupational therapists. This is different to the previous Intervention pathway, as there is some difference between the timing of certain elements of care provided.
Control group
Active

Outcomes
Primary outcome [1] 297104 0
Length of hospital stay between the two arms of the study. This is assessed by using the hospital admission system and a review of the patient's medical record.
Timepoint [1] 297104 0
Length of hospital stay between the two arms of the study. The length of stay is from the end of the procedure to the hospital discharge.
Secondary outcome [1] 320027 0
Additional post operative complications, The post operative outcomes that we will be assessing are as follows. Deep venous thrombosis (DVT) or pulmonary embolism (PE)
Superficial incisional surgical site infection
Prosthetic joint infection
Other Health Care Associated Infection
Clostridium difficile infection
Blood stream infection (BSI) including central-line associated BSI
Pneumonia including ventilator-associated pneumonia
Urinary tract infection (UTI) including catheter associated UTI
Decubitus ulcer infection
Post-operative delirium
Postoperative acute urinary retention
Postoperative pressure ulcer
Postoperative acute kidney injury
Postoperative cardiac complications; acute myocardial infarction or arrhythmia requiring treatment
Clinically or radiologically confirmed atelectasis

These are assessed based on medical record reviews from the patients stay in hospital.
The Clinical Outcomes Clinical Outcome's Assessment questionnaire will also be administered, which has been designed by the research team for this study, to capture any post operative complications. Any information provided will be verified by medical record review.
Timepoint [1] 320027 0
At the following time points: 30 days post surgery, 90 days post surgery, 6 months post surgery, 12 months post surgery, 24 months post surgery.
Secondary outcome [2] 320030 0
Patient's quality of life (as reported by surveys). The surveys that are used are the EQ5D, WOMAC, and the VF-12, which are the validated tools.
Timepoint [2] 320030 0
At the following time points: 30 days post surgery, 90 days post surgery, 6 months post surgery, 12 months post surgery, 24 months post surgery.
Secondary outcome [3] 324146 0
Cost-effectiveness analysis between the intervention and the control group, using data linkage with MBS/PBS, for the period of 24 months post surgery.
Timepoint [3] 324146 0
24 months post surgery

Eligibility
Key inclusion criteria
Patient undergoing elective, primary, hip or knee joint replacement surgery at St Vincent's Hospital, Melbourne, Australia
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
The exclusion criteria for this study is as follows
* Patients under 18 years of age
* Patients whose primary language is other than English (LOTE)
* Revision hip or knee joint replacement
* Unicompartmental knee joint replacement
* Traumatic joint arthoplasty including fractured neck of femur
* Prosthetic joint replacement for bone or soft tissue tumour
* Patients requiring admission to rehabilitation on pre-admission screening
* High risk patients with planned admission to Intensive Care Unit or High Dependency Unit following prosthetic joint replacement as determined by the Perioperative Care Physician.

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 will be concealed. Allocation involved phone dial in to a central randomization service by the study coordinator, which occurs once the patient had been approached and consented by the study coordinator.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
At an individual patient level in a 1:1 ratio, stratified in blocks dependent on whether the patient is undergoing hip or knee replacement. Randomisation of participants to treatment arms will be coordinated by a dial-in, voice-response system with concealed allocation.
We are using computer randomisation service provided by the NHMRC Clinical Trials Centre
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis
The primary statistical analysis will be an intent-to-treat analysis on the entire sample. There will also be additional statistical tests to determine the cost-effectiveness of the intervention and to evaluate the success of the blinding of the intervention
The sample size estimate for this trial is 35 participants per study arm (total n =70 participants) based on the following parameters: average length of stay of 5.5 days (standard deviation 2.5) drawn from the St Vincent's Arthroplasty Outcomes Registry Data (SMART Registry); an estimated 2.3 day reduction in LOS based on the lower limit of the 95% confidence rate reported by Larsen et al (2008) a comparable randomized controlled trial, power of 80%; an alpha value of 5%. To allow for a loss to follow up rate of 10% this trial will recruit 80 participants in total.

Recruitment
Recruitment status
Active, not 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)
VIC
Recruitment hospital [1] 5091 0
St Vincent's Hospital (Melbourne) Ltd - Fitzroy
Recruitment postcode(s) [1] 12556 0
3065 - Fitzroy

Funding & Sponsors
Funding source category [1] 292716 0
Charities/Societies/Foundations
Name [1] 292716 0
BUPA Health Foundation Grant
Address [1] 292716 0
Bupa Health Foundation
Bupa
GPO Box 9809
Brisbane, QLD
4001
Country [1] 292716 0
Australia
Primary sponsor type
Individual
Name
Dr Trisha Peel
Address
Department of Surgery,
University of Melbourne
Clinical Sciences Building
Level 2
29 Regent Street
Fitzroy
VIC 3065
Country
Australia
Secondary sponsor category [1] 291575 0
Individual
Name [1] 291575 0
Professor Peter Choong
Address [1] 291575 0
Department of Surgery,
University of Melbourne
Clinical Sciences Building
Level 2
29 Regent Street
Fitzroy
VIC 3065
Country [1] 291575 0
Australia
Secondary sponsor category [2] 291576 0
Individual
Name [2] 291576 0
Dr Michelle Dowsey
Address [2] 291576 0
Department of Surgery,
University of Melbourne
Clinical Sciences Building
Level 2
29 Regent Street
Fitzroy
VIC 3065
Country [2] 291576 0
Australia
Secondary sponsor category [3] 291577 0
Individual
Name [3] 291577 0
Dr Timothy Spelman
Address [3] 291577 0
Department of Surgery,
University of Melbourne
Clinical Sciences Building
Level 2
29 Regent Street
Fitzroy
VIC 3065
Country [3] 291577 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294339 0
St Vincent's Hospital (Melbourne) HREC-A
Ethics committee address [1] 294339 0
Research Governance Unit
St Vincent's Hospital
PO Box 2900
Fitzroy VIC 3065
Ethics committee country [1] 294339 0
Australia
Date submitted for ethics approval [1] 294339 0
16/02/2016
Approval date [1] 294339 0
11/04/2016
Ethics approval number [1] 294339 0
HREC-A 028/16

Summary
Brief summary
Prosthetic joint replacement is a high cost and high volume procedure in Australia. In 2015, it is expected that over 100,000 joint replacements will be performed. The aim of the STEP Study is to compare two different clinical care pathways to see which pathway is best at helping patients recover from their surgery. At present it is unknown if one of these clinical care pathways is better than the other or whether they are both equally effective.
The study will compare length of stay and the costs associated with the care pathways, along with patient reported outcomes (in the form of questionnaires), health economic analysis and adverse event assessment.
This is a single centre, parallel design, pragmatic randomised controlled trial.
Trial website
Trial related presentations / publications
Public notes
Please Note, This clinical trial is only available to patients enrolled on the waiting list for Total Joint Replacement at St Vincent's Hospital, Melbourne, Australia, who fit the inclusion criteria and consent to being a part of this trial.

Contacts
Principal investigator
Name 62882 0
Dr Trisha Peel
Address 62882 0
Department of Orthopaedics
St Vincent's Hospital
Level 3, Daly Wing
35 Victoria Parade
Fitzroy
Victoria 3065
Country 62882 0
Australia
Phone 62882 0
+613 92 133 969
Fax 62882 0
+613 94 103 610
Email 62882 0
tnpeel@unimelb.edu.au
Contact person for public queries
Name 62883 0
Ms Claire Weeden
Address 62883 0
Department of Orthopaedics
St Vincent's Hospital
Level 3, Daly Wing
35 Victoria Parade
Fitzroy
VIC 3065
Country 62883 0
Australia
Phone 62883 0
+613 92 314 586
Fax 62883 0
+613 92 312 131
Email 62883 0
svhm.step@svha.org.au
Contact person for scientific queries
Name 62884 0
Ms Claire Weeden
Address 62884 0
Department of Orthopaedics
St Vincent's Hospital
Level 3, Daly Wing
35 Victoria Parade
Fitzroy
VIC 3065
Country 62884 0
Australia
Phone 62884 0
+613 92 314 586
Fax 62884 0
+613 92 312 131
Email 62884 0
svhm.step@svha.org.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary