Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202103637993156 Date of Approval: 29/03/2021
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Physiotherapy in an advanced rehabilitation pathway after hip and knee arthroplasty in South Africa.
Official scientific title Early mobilisation and frequency of physiotherapy after hip and knee arthroplasty.
Brief summary describing the background and objectives of the trial An increased life expectancy, giving rise to osteoarthritis(OA), with an increase in future elective arthroplasty surgeries caused by the Covid-19 pandemic backlog, medical funders and governmental resources may be burdened. Advanced rehabilitation pathways (ARP) decrease patients' hospital length of stay(LOS), proposing a possible solution. A lack of evidence exists investigating physiotherapy as part of the ARP and its outcomes in South Africa (SA). The study aims to determine whether early mobilisation and increased frequency of physiotherapy treatments for participants after hip or knee arthroplasty surgery on post-surgical day 0(POD 0) in a private hospital in SA affect outcomes. A quantitative prospective cohort study incorporating an ARP on (n=60) non-randomised elective hip and knee arthroplasty participants will be compared to a conservatively managed historical control group (n=60), total 120. Outcomes measures per outcome are; hours for LOS, the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) for patient satisfaction (pain, function, stiffness, and expectation) pre-operatively, six weeks and three months post-surgically, 30-day readmission for safety, and simple cost comparison between the prospective and historical cohorts. The objectives of the study are: To determine how early mobilisation and the increased frequency of physiotherapy on POD 0 impacts hospital LOS in mean hours rather than in days. To measure patient satisfaction (pain, function, stiffness, and expectation) six weeks and three months post-surgical, using The Western Ontario and McMaster Universities Osteoarthritis Index(WOMAC). To evaluate the safety of implementing an accelerated rehabilitation pathway, documenting any adverse events, 30-day readmission date. To determine and compare the costs of LOS, by calculating the cost of direct hospital expenses incurred per day, theatre time, assistive devices (crutches or walking frames), prosthetic, costs/fees paid.
Type of trial CCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Orthopaedics,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Rehabilitation
Anticipated trial start date 01/07/2020
Actual trial start date
Anticipated date of last follow up 23/07/2021
Actual Last follow-up date
Anticipated target sample size (number of participants) 120
Actual target sample size (number of participants) 120
Recruitment status Recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Crossover: all participants receive all interventions in different sequence during study Non-randomised Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Early mobilisation and frequency of physiotherapy The physiotherapy protocol starts with pre-operative education, pre-habilitation (rehabilitation performed by the physiotherapist before the surgery) and evaluation session. This session emphasises post-surgical expectations from the patient and physiotherapist, post-surgical exercises, bed mobility, gait re-education, navigating stairs with crutches, preventive measures, early mobilisation, ice programme, discharge requirements, and information about in-hospital as well as follow-up physiotherapy sessions. The physiotherapy post-surgically starts by sitting the patient more upright (while respecting hip flexion precaution of 90° after total hip replacements) to assist with hypotension. Bed exercises consisting of foot pumps, static quadriceps muscle strengthening exercises, free active hip abduction ROM exercises, and heel slides exercises to encourage joint ROM are performed. The bed exercise prescription is one set of 10 repetitions, a minimum of five times per day. The patient is then mobilised to sit over the side of the bed. While the patient sits over the side of the bed, a short lever quadriceps extension exercise is prescribed. If the patient has no dizziness, nausea, or intense pain, standing with a walking frame follows. Gait and knee-locking are explained, a revision of the education performed during the pre-habilitation phase. Then the patient mobilises from the bed to the toilet and back, approximately 20 metres in total. If the patient is mobilising well with a walking frame, they can walk with elbow crutches. Ice is re-applied after the mobilisation. The patient is encouraged to sit out in the chair for lunch and dinner. A second physiotherapy session, two to three hours from the first physiotherapy session, follows. The second physiotherapy session comprises the same exercises and mobilisation programme as the first session. The physiotherapist will also help the patient to get dressed in their clothes during the second session. Patients will receive physiotherapy sessions twice per day while in hospital. Same as above for all included participants prospectively and retrospectively. The physiotherapy protocol starts with pre-operative education, pre-habilitation (rehabilitation performed by the physiotherapist before the surgery) and evaluation session. This session emphasises post-surgical expectations from the patient and physiotherapist, post-surgical exercises, bed mobility, gait re-education, navigating stairs with crutches, preventive measures, early mobilisation, ice programme, discharge requirements, and information about in-hospital as well as follow-up physiotherapy sessions. The physiotherapy post-surgically starts by sitting the patient more upright (while respecting hip flexion precaution of 90° after total hip replacements) to assist with hypotension. Bed exercises consisting of foot pumps, static quadriceps muscle strengthening exercises, free active hip abduction ROM exercises, and heel slides exercises to encourage joint ROM are performed. The bed exercise prescription is one set of 10 repetitions, a minimum of five times per day. The patient is then mobilised to sit over the side of the bed. While the patient sits over the side of the bed, a short lever quadriceps extension exercise is prescribed. If the patient has no dizziness, nausea, or intense pain, standing with a walking frame follows. Gait and knee-locking are explained, a revision of the education performed during the pre-habilitation phase. Then the patient mobilises from the bed to the toilet and back, approximately 20 metres in total. If the patient is mobilising well with a walking frame, they can walk with elbow crutches. Ice is re-applied after the mobilisation. The patient is encouraged to sit out in the chair for lunch and dinner. A second physiotherapy session, two to three hours from the first physiotherapy session, follows. The second physiotherapy session comprises the same exercises and mobilisation programme as the first session. 60
Control Group Early mobilisation and frequency of physiotherapy Pre and post operatively. Till discharge from the hospital. The physiotherapy post-surgically starts by sitting the patient more upright (while respecting hip flexion precaution of 90° after total hip replacements) to assist with hypotension. Bed exercises consisting of foot pumps, static quadriceps muscle strengthening exercises, free active hip abduction ROM exercises, and heel slides exercises to encourage joint ROM are performed. The bed exercise prescription is one set of 10 repetitions, a minimum of five times per day. The patient is then mobilised to sit over the side of the bed. While the patient sits over the side of the bed, a short lever quadriceps extension exercise is prescribed. If the patient has no dizziness, nausea, or intense pain, standing with a walking frame follows. Gait and knee-locking are explained, a revision of the education performed during the pre-habilitation phase. Then the patient mobilises from the bed to the toilet and back, approximately 20 metres in total. If the patient is mobilising well with a walking frame, they can walk with elbow crutches. Ice is re-applied after the mobilisation. The patient is encouraged to sit out in the chair for lunch and dinner. A second physiotherapy session, two to three hours from the first physiotherapy session, follows. The second physiotherapy session comprises the same exercises and mobilisation programme as the first session. The physiotherapist will also help the patient to get dressed in their clothes during the second session. In-between the two physiotherapy sessions, the patient, may mobilise with the nursing staff's assistance to the bathroom if the need arises. Depending on how well and safe the patient is mobilising, stair climbing might be included in the second session on POD 0, or in the first physiotherapy session on post-surgical day one. 60 Historical
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
All, elective hip, and knee arthroplasty patients, cleared by the physician, as per clinical advanced protocol, will be included. Patients with revision surgery, trauma related surgeries, bilateral arthroplasty, poor balance, and cognitive deficiencies will be excluded from the study. 80 and over: 80+ Year,Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 19 Year(s) 95 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 30/06/2020 Human Research Ethics CommitteeMedical
Ethics Committee Address
Street address City Postal code Country
8 York Street, Parktown, Gauteng Johannesburg 2193 South Africa
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Secondary Outcome Patient satisfaction (pain, function, stiffness, and expectation). Six weeks and three months post-operative
Primary Outcome Length of hospital stay. On discharge.
Secondary Outcome Cost analysis Three months
Secondary Outcome 30 days readmission due to complications. Before 30 days post-operatively.
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Medicare and Peglarae 271 Beyers Naude Drive Rustenburg South Africa
FUNDING SOURCES
Name of source Street address City Postal code Country
University of the Witwatersrand 8 York Street Johannesburg 2193 South Africa
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor R Prinsloo 271 Beyers Naude Street Rustenburg South Africa Individual
COLLABORATORS
Name Street address City Postal code Country
Retha Mari Prinsloo 52 Heystek Street Rustenburg South Africa
Monique Keller 8 York Street Johannesburg South Africa
Dr Theo Potgieter 52 Heystek Street Rustenburg South Africa
CONTACT PEOPLE
Role Name Email Phone Street address
Scientific Enquiries Monique M. Keller monique.keller@wits.ac.za +27117173517 8 York Street,
City Postal code Country Position/Affiliation
Parktown 2193 South Africa Lecturer
Role Name Email Phone Street address
Principal Investigator Retha Mari Prinsloo prinsloophysio@gmail.com +27145921048 52 Heystek Street,
City Postal code Country Position/Affiliation
Rustenburg 0299 South Africa Postgraduate student
Role Name Email Phone Street address
Public Enquiries Benita Olivier benita.olivier@wits.ac.za +277173702 8 York Street,
City Postal code Country Position/Affiliation
Parktown 2193 South Africa Research Coordinator
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes The individual participant data that underlie the results reported in this article, will be made available to investigators who's proposed use of the data has been approved by an independent review committee, after deidentification (tables, figures, text and appendices). Study Protocol Between 9 and 36 months from the data of publication of the results. To confirm still.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
https://orcid.org/0000-0002-1513-295X No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
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