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The STEP study: A Pragmatic, randomized, controlled trial comparing two post operative management pathways in knee or hip replacement surgery

The STEP study: A Pragmatic, randomized, controlled trial comparing two post operative management pathways in knee or hip replacement surgery

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12616000696493
Acronym
STEP
Enrollment
79
Registered
2016-05-26
Start date
2016-06-27
Completion date
2018-02-08
Last updated
2022-08-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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

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.

Sponsors

Dr Trisha Peel
Lead SponsorIndividual

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Patient undergoing elective, primary, hip or knee joint replacement surgery at St Vincent's Hospital, Melbourne, Australia

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.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026