Study of Hip and Knee Arthroplasty in South Africa

Osteoarthritis, Knee Clinical Trial

Official title:

Prospective Observational Study of Current Perioperative Care for Hip and Knee Arthroplasty in South Africa, and Associated Outcomes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03540667
• Other study ID #: The BETTER care protocol - 1
• Status: Completed
• Start date: May 7, 2018
• Est. completion date: January 30, 2019

Study information

• Verified date: August 2020
• Source: University of Cape Town
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This multi-site, observational, prospective study aims to investigate current practice and associated outcomes for patients scheduled for elective unilateral total hip or knee arthroplasty in South Africa.This information will provide baseline values, against which effects of implementing a multidisciplinary enhanced care protocol for arthroplasty patients will be compared (the subsequent study).

Description:

RESEARCH PROBLEM:

In the past 20 years, enhanced recovery pathways (ERPs) have become increasingly integrated into most surgical fields as standard care in high income countries, as is exemplified by national priority programs and the widespread acceptance of the Enhanced Recovery After Surgery (ERAS) society network. ERPs represent a fundamental shift towards a patient-centred, multidisciplinary-driven continuity of care that aim to attenuate surgical stress and expedite recovery. Studies on total joint arthroplasty (TJA) for both hips and knees have shown that implementation of an evidence-based, structured approach to patient care decreases postoperative morbidity and consequently length of stay without increasing readmission rate.

However, in low- and middle-income countries, the value of implementing ERPs is yet to be explored. This may be because: i) the perception that current hospital resources may make it difficult to develop and implement structured and sustainable protocols to enhance postoperative recovery, and ii) short and long-term data collection on the quality of the work provided is scarce, inhibiting the ability to benchmark clinical results and improve the service provided to patients. Despite these challenges, a healthcare system in a middle-income country such as South Africa may benefit from the implementation of ERPs through reduced postoperative morbidity and the associated cost reductions, as has been demonstrated in high-income countries.

STUDY RATIONAL:

Documentation of current perioperative interventions with associated postoperative outcomes is crucial before implementing a new model for perioperative care. As such, this study will give the investigators baseline values against which the perioperative results achieved from instituting a multidisciplinary enhanced care programme for South African arthroplasty patients will be analyzed.

STUDY DESIGN:

This is a 10-week prospective observational audit of patients scheduled for primary elective unilateral total hip or knee arthroplasty at 9 District, Regional and Central hospitals in South Africa.

PATIENT RECRUITMENT, DATA COLLECTION AND CONFIDENTIALITY:

The patients will be recruited consecutively by the orthopaedic surgeons in the preoperative arthroplasty clinic or when presenting for admission before surgery (minimum 1 day before surgery). Staff from the departments of orthopaedic surgery, physiotherapy and anaesthesia will be responsible for in-hospital data capture. Telephonic follow-up interviews 30 days and 12 months after surgery will be conducted by the Principal Investigator or dedicated research assistants. The patients will be informed that they can choose to leave the study at any time during the study period.

Each individual center will collect and record data on either an electronic or paper case record form (CRF) for every patient recruited. Access to the data entry system will be protected by username and password delivered during the registration process for individual local investigators. All electronic data transfer between participating centres and the coordinating center will be encrypted using a secure protocol (HTTPS/SSL 3.0 or better).

TIME FRAME:

The study will run for 10 weeks at each enrolled site. The in-hospital and 30 day data collection is expected to be completed in 2018.

RISK AND BENEFITS:

Participation in the study will not add any risk to the patient, why the patient's safety is intact. Principles of Helsinki and Good Clinical Practice will be adhered to.

SAMPLE SIZE CALCULATION AND STATISTICAL ANALYSIS:

As knowledge on current postoperative outcomes after hip and knee arthroplasty in South Africa is scarce, this study is a descriptive hypothesis generating study to establish baseline data for future studies, and hence there is no formal power calculation for this study's primary outcome; Days alive and at home 30 days after surgery (DAH30). However, in the study by Myles and colleagues (Myles et al. BMJ Open. 2017; 7(8): e015828. Published online 2017 Aug 18. doi: 10.1136/bmjopen-2017-015828) patient cohorts of approximately 200 patients resulted in clinically relevant and acceptable 95% CI, why we aim to enrol minimum 200 patients. The data are expected to be non-parametric and will be presented as median with interquartile range (25-75 percentile).

As the investigators are unaware of any publications of South African orthopaedic patients which report the specified secondary outcomes, the data will be used to establish a baseline incidence in South African arthroplasty patients for HRQoL (preoperative, 30 days and 12 months postoperative), TUG (in-hospital day 3), mortality (12 months postoperative) and prosthetic joint infection and joint revision (12 months postoperative). These data will be used to power future interventional studies.

Continuous variables will be described using sample mean and standard deviation (SD) and categorical variables using sample median and interquartile range (IQR). Where statistical comparisons are to be made between continuous variables, the unpaired t-test or Mann Whitney U test will be used as appropriate. Categorical data will be compared using the χ2 test.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 206
• Est. completion date: January 30, 2019
• Est. primary completion date: January 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• All patients scheduled for primary elective unilateral total hip or knee arthroplasty in the 10 week study period at the 10 participating study sites in South Africa.

• Patients must accept to be contacted telephonically 30 days and 12 months after surgery.

Exclusion Criteria:

• Patients who do not have a mobile telephone.

Related Conditions & MeSH terms

• Arthritis
• Arthritis Knee
• Arthritis of Hip
• Arthritis, Rheumatoid
• Osteoarthritis
• Osteoarthritis, Hip
• Osteoarthritis, Knee

Locations

Country	Name	City	State
South Africa	Universitas Academic Hospital	Bloemfontein	Free State
South Africa	Groote Schuur Hospital	Cape Town	Western Cape
South Africa	Mitchells Plain Hospital	Cape Town	Western Cape
South Africa	Somerset Hospital	Cape Town	Western Cape
South Africa	Victoria Hospital	Cape Town	Western Cape
South Africa	Albert Luthuli Central Hospital	Durban	KwaZulu-Natal
South Africa	Paarl Hospital	Paarl	Western Cape
South Africa	Grey's Hospital	Pietermaritzburg	KwaZulu-Natal
South Africa	Steve Biko Academic Hospital	Pretoria	Gauteng

Sponsors (1)

Lead Sponsor	Collaborator
University of Cape Town

Country where clinical trial is conducted

South Africa, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	"Days alive and at home 30 days after surgery" (DAH30)	A patient centered measure which integrates length of hospital stay, readmission due to postoperative complications, discharge destination and early death after surgery . This outcome is an overall measure of the recovery profile as it captures much of the surgical experience, integrating efficacy, quality and safety thus reflecting value based care and actions. As such, DAH30 is transparent and can be used for benchmarking performance of quality of perioperative care.	30 days
Secondary	Timed Up and Go test	Timed Up and Go (TUG) is a clinical performance based measure of lower extremity function, mobility and fall risk. It measures how long it takes a patient to get up from a chair, walk 3 meters and return to sitting in the chair. The Physiotherapist will perform TUG on day 3 after surgery. If the patient is discharged earlier, the TUG test will be performed on discharge. If the TUG test can't be performed (ex. lack of personnel on week-ends) the TUG will be performed on day 5 after surgery, unless the patient is discharged earlier than day 5 - in that case the TUG will be performed on discharge.	2-5 days after surgery
Secondary	EQ-5D	Defines health based on 5 dimensions; mobility, self-care, usual activities, pain/discomfort and anxiety/depression.	30 days and 1 year after surgery
Secondary	EQ-VAS	Visual analogue scale (VAS) generates a self-rated Health Related Quality of Life score.	30 days and 1 year after surgery
Secondary	Satisfaction with surgery	To assess overall patient satisfaction with the surgery we will ask the question: "To better understand how satisfied you are with the operation, we would like to know if you would have this operation again, if it were required on the other joint"? (yes/no).	30 days and 1 year after surgery
Secondary	1-year incidence of mortality	Incidence of mortality 1 year after surgery	1 year follow up
Secondary	Prosthetic joint infection rate	Incidence of prosthetic joint infection 1 year after surgery	1 year follow up
Secondary	Joint revision	Incidence of joint revision 1 year after surgery	1 year follow up