Clinical trial NCT03540667: Study of Hip and Knee Arthroplasty in South Africa
Official title: Prospective Observational Study of Current Perioperative Care for Hip and Knee Arthroplasty in South Africa, and Associated Outcomes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Osteoarthritis, Knee
Osteoarthritis, Hip
Arthritis, Rheumatoid
Arthritis Knee
Arthritis of Hip
Keywords: Total hip arthroplasty
Total knee arthroplasty
Total joint arthroplasty
Low middle income country
Enhanced recovery pathway
Lead sponsor: University of Cape Town
Sponsor class: OTHER
First posted: 2018-05-30
Enrollment: 206
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients scheduled for primary elective unilateral total hip or knee arthroplasty.

Brief 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).

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: "Days alive and at home 30 days after surgery" (DAH30)
timeFrame: 30 days
Secondary outcomes:
measure: Timed Up and Go test
timeFrame: 2-5 days after surgery
measure: EQ-5D
timeFrame: 30 days and 1 year after surgery
measure: EQ-VAS
timeFrame: 30 days and 1 year after surgery
measure: Satisfaction with surgery
timeFrame: 30 days and 1 year after surgery
measure: 1-year incidence of mortality
timeFrame: 1 year follow up
measure: Prosthetic joint infection rate
timeFrame: 1 year follow up
measure: Joint revision
timeFrame: 1 year follow up
Other outcomes:
Locations:
city: Bloemfontein
country: South Africa
facility: Universitas Academic Hospital
state: Free State
city: Pretoria
country: South Africa
facility: Steve Biko Academic Hospital
state: Gauteng
city: Durban
country: South Africa
facility: Albert Luthuli Central Hospital
state: KwaZulu-Natal
city: Pietermaritzburg
country: South Africa
facility: Grey's Hospital
state: KwaZulu-Natal
city: Cape Town
country: South Africa
facility: Mitchells Plain Hospital
state: Western Cape
city: Cape Town
country: South Africa
facility: Somerset Hospital
state: Western Cape
city: Cape Town
country: South Africa
facility: Victoria Hospital
state: Western Cape
city: Cape Town
country: South Africa
facility: Groote Schuur Hospital
state: Western Cape
city: Paarl
country: South Africa
facility: Paarl Hospital
state: Western Cape
Study officials:
affiliation: University of Cape Town
name: Ulla Plenge, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Plenge U, Parker R, Davids S, Davies GL, Fullerton Z, Gray L, Groenewald P, Isaacs R, Kauta N, Louw FM, Mazibuko A, North DM, Nortje M, Nunes GM, Pebane N, Rajah C, Roos J, Ryan P, September WV, Shanahan H, Siebritz RE, Smit RW, Sombili S, Torborg A, van der Merwe JF, van der Westhuizen N, Biccard B. Quality of recovery after total hip and knee arthroplasty in South Africa: a national prospective observational cohort study. BMC Musculoskelet Disord. 2020 Nov 5;21(1):721. doi: 10.1186/s12891-020-03752-x.