Arthroplasty and Modifiable Risk Factors
Primary Purpose
Total Joint Arthroplasty, Risk Reduction, Surgical Site Infection
Status
Completed
Phase
Not Applicable
Locations
Iceland
Study Type
Interventional
Intervention
Early preoperative assessment and optimization
Sponsored by
About this trial
This is an interventional prevention trial for Total Joint Arthroplasty
Eligibility Criteria
Inclusion Criteria:
- All adult patients undergoing elective primary arthroplasty of either hip or knee at Landspitali University Hospital
Exclusion Criteria:
- Contraindications for operation detected after inclusion. Patients having an operation on another joint within the inclusion period were not re-included.
Sites / Locations
- Landspitali University Hsopital
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Control group
Early preoperative assessment and optimization
Arm Description
Usual care group - receiving traditional preoperative preparation and assessment (1 week) prior to total joint arthroplastic surgery
Interventional group - receiving early preoperative assessment and optimization (6-12 months) in wait of total joint arthroplastic surgery
Outcomes
Primary Outcome Measures
Number of Participants with Surgical site infection
Evaluated according to CDC's National Healthcare Safety Network
Number of Participants with Surgical site infection
Evaluated according to CDC's National Healthcare Safety Network
Number of Participants with Prosthetic joint infection
Evaluated according to CDC's National Healthcare Safety Network
Number of Participants with Prosthetic joint infection
Evaluated according to CDC's National Healthcare Safety Network
Secondary Outcome Measures
Preoperative anemia according to WHO's definition
Hemoglobin in blood - Preoperative anemia was defined according to WHO's definition as a haemoglobin concentration of <120 g/l and < 130 g/l in women and men, respectively, and divided into mild (110 - 120/130 g/L per gender), moderate (80-109 g/L) and severe (<80 g/L).
Control of diabetes
HbA1c level - Patients were considered to have diabetes if they had received this diagnosis preoperatively or had a HbA1c level >47 mmol/mol. Non-diabetic patients were considered to have dysglycemia if HbA1c was 42 - 47 mmol/mol and undiagnosed diabetes if HbA1c >47mmol/mol.
Indication of poor glucose control
Serum Glucose level
Nutritional status
S- albumin - Patients with <35g/L (3.5 g/dL) were considered to be at risk of malnutrition
Nutritional status
Lymphocyte count - Patients with <1,5 x 10E9/L 32 were considered to be at risk of malnutrition
Nutritional status
D-Vitamin - Patients with 25OHD concentration < 50 nmol/L were defined as having a deficiency
Smoking
Information of smoking habits were acquired through a questionnaire and divided into those that had quit smoking more than a year ago >than 6 months ago, >6 weeks ago, less than 6 weeks ago and current smokers
Physical activity
Information of amount of weekly physical activity was acquired through a questionnaire and divided into two classes, zero to two times per week and three to five times per week. Each occasion was graded from 1 to more than 60 minutes.
Other postoperative complications
Information from health records
Full Information
NCT ID
NCT05399186
First Posted
May 19, 2022
Last Updated
October 2, 2023
Sponsor
Landspitali University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05399186
Brief Title
Arthroplasty and Modifiable Risk Factors
Official Title
Incidence of Modifiable Risk Factors and Their Association With Infections in Primary Elective Arthroplastic Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
August 20, 2018 (Actual)
Primary Completion Date
December 31, 2022 (Actual)
Study Completion Date
December 31, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Landspitali University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Hip and knee total joint arthroplasty are one of the most frequently performed surgery worldwide. However, prosthetic joint infection remains a devastating complication of them, associated with severe morbidity, increased mortality and huge costs. Several underlying medical conditions that have been identified as independent risk factors for development of prosthetic joint infection.
The hypothesis of the study is that by utilizing the waiting time for operation (6 -12 months) to improve the state of known modifiable risk factors the frequency of prosthetic joint infection may be decreased. This optimization was established with co-operation between hospital and primary care.
Therefore a prospective non-randomized quality control study before and after an intervention regarding preoperative preparation for total joint arthroplasty of either hip or knee was planned.
The control arm was included one week prior to surgery at the anesthesia preoperative assessment outpatient clinic and were operated on between 27/8 2018 and 7/9 2020 and consists of 738 patients.
Inclusion of the interventional arm happened at the orthopedic outpatient clinic from 2/1 2019 - 30/1 2021, 6 -12 months prior to surgery and an appointment with their general physician ensured within 3 weeks for further evaluation. Enlisted have been 1010 patients, operation of them started 25/3 2019 and to date 710 patients have been operated on, but due to delays caused by Covid-19 (SARS-CoV-2) surgery of them is still ongoing.
The effect of the intervention will be evaluated with by comparison of patient characteristics and frequency of surgical site and prosthetic joint infections before and after.
Detailed Description
Hip and knee total joint arthroplasty allow effective treatment of disability and pain due to joint destruction, and are one of the most frequently performed surgery worldwide. Surgical-site infections remain a serious complication of total joint arthroplasty, occurring in 1-7% of cases. The most severe form of surgical site infection, prosthetic joint infection is a devastating complication associated with severe morbidity, increased mortality and huge costs. There are several underlying medical conditions that have been identified as independent risk factors for development of prosthetic joint infection that might be improved before operation, called modifiable risk factors, namely pre-operative anemia, obesity, diabetes, poor nutritional status, smoking and physical activity.
The hypothesis of the study is that by utilizing the waiting time for operation (6 -12 months) to improve the state of known modifiable risk factors the frequency of prosthetic joint infection may be decreased. This optimization was established with co-operation between hospital and primary care.
Therefore a prospective non-randomized quality control study before and after an intervention regarding preoperative preparation for total joint arthroplasty of either hip or knee, comparing patient characteristics and outcome was planned.
Control Arm: Inclusion of 'usual care' patients started 20/8 2018 one week prior to surgery at the anesthesia preoperative assessment outpatient clinic. At that point in time there were 561 patients already on a waiting list for either hip or knee arthroplastic surgery. The next four months to 31/12 2018 66 more patients were added to the study. After 1/1 2019 (when collection to the interventional part had started) further 111 patients were added (15% of the 'usual care' group). These were patients where it had been missed to offer or had declined participation in the interventional arm of the study at the orthopedic outpatient clinic and when discovered at the preoperative clinic one week prior to surgery were offered participation in the 'usual care' arm as they had received traditional preoperative preparation. Operation of these patients started at 27/8 2018 and lasted to 7/9 2020 and consists of total of 738 individuals.
Interventional arm: Inclusion into the interventional arm of the study occurred between 2/1 2019 to 30/1 2021, 6 -12 months prior to surgery at the orthopedic outpatient clinic, ensuring an appointment with the patient general physician within 3 weeks afterwards to further analyze results of blood test and assess if further tests, treatments or consultation of other specialists would be preferred to optimize their condition. Patients at extremes of BMI also had a nutritional advice at the hospital. Enlisted have been 1010 patients, operation of them started 25/3 2019 and to date 710 patients have been operated on, but due to delays caused by COVID-19 (SARS-CoV-2) surgery of them is still ongoing.
Outcome variables: Information was gathered regarding age, gender, smoking, comorbidities, type of surgery, type of anesthesia, ASA classification, weight, physical activity, laboratory values (Hb, Glu, HbA1c, Albumin. Lymphocytes, D-vitamin), blood transfusions and length of stay. Postoperative follow up happened first 3 weeks postoperatively at primary care for suture removal and then 6 weeks at the outpatient orthopedic clinic. Notes from these visits were studied to identify surgical site complications, including surgical site infection, prosthetic joint infection, surgical site drainage, bleeding, dehiscence, and hematoma and evaluated according to CDC's National Healthcare Safety Network and PJI diagnosis. Also, a two year follow will occur by analysis of patient journal in regards of complications of the arthroplasty.
Statistical methods. Patient demographics will be described as median (interquartile range) for continuous variables, and number (percentage) for categorical variables. Mean and standard deviation (SD) will be reported for normally distributed data. A univariate association between the presence of modifiable risk factors and the presence of postoperative surgical site infection will be assessed using chi-squared test for categorical variables and t-test for continuous variables. As this is a descriptive study and incidence of modifiable risk factors not known in the cohort no assessment of power was performed prior to analysis. To study if there is a difference between the groups a t-test or non-parametric Wilcoxon rank sum test or Hotelling's t will be used for continuous parameters, and chi-squared test or Fisher's exact test to compare categorical parameters. Poisson regression or negative binominal regression of zero inflated regression will be used to study if a difference in the frequency of complications has occurred after the intervention. These methods might be subjected to change if unexpected factors arise during analysis of data.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Total Joint Arthroplasty, Risk Reduction, Surgical Site Infection, Prosthetic-joint Infection, Postoperative Complications
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Model Description
A prospective non-randomized quality control study before and after an intervention regarding preoperative preparation for total joint arthroplasty
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
1484 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Usual care group - receiving traditional preoperative preparation and assessment (1 week) prior to total joint arthroplastic surgery
Arm Title
Early preoperative assessment and optimization
Arm Type
Experimental
Arm Description
Interventional group - receiving early preoperative assessment and optimization (6-12 months) in wait of total joint arthroplastic surgery
Intervention Type
Other
Intervention Name(s)
Early preoperative assessment and optimization
Intervention Description
The interventional group received early preoperative assessment and optimization (6-12 months) prior to total joint arthroplastic surgery in cooperation between hospital and primary care
Primary Outcome Measure Information:
Title
Number of Participants with Surgical site infection
Description
Evaluated according to CDC's National Healthcare Safety Network
Time Frame
6 weeks postoperatively
Title
Number of Participants with Surgical site infection
Description
Evaluated according to CDC's National Healthcare Safety Network
Time Frame
2 years postoperatively
Title
Number of Participants with Prosthetic joint infection
Description
Evaluated according to CDC's National Healthcare Safety Network
Time Frame
6 weeks postoperatively
Title
Number of Participants with Prosthetic joint infection
Description
Evaluated according to CDC's National Healthcare Safety Network
Time Frame
2 years postoperatively
Secondary Outcome Measure Information:
Title
Preoperative anemia according to WHO's definition
Description
Hemoglobin in blood - Preoperative anemia was defined according to WHO's definition as a haemoglobin concentration of <120 g/l and < 130 g/l in women and men, respectively, and divided into mild (110 - 120/130 g/L per gender), moderate (80-109 g/L) and severe (<80 g/L).
Time Frame
At inclusion, 1 week prior to and one day after surgery
Title
Control of diabetes
Description
HbA1c level - Patients were considered to have diabetes if they had received this diagnosis preoperatively or had a HbA1c level >47 mmol/mol. Non-diabetic patients were considered to have dysglycemia if HbA1c was 42 - 47 mmol/mol and undiagnosed diabetes if HbA1c >47mmol/mol.
Time Frame
At inclusion, 1 week prior to and one day after surgery
Title
Indication of poor glucose control
Description
Serum Glucose level
Time Frame
At inclusion, 1 week prior to and one day after surgery
Title
Nutritional status
Description
S- albumin - Patients with <35g/L (3.5 g/dL) were considered to be at risk of malnutrition
Time Frame
At inclusion, 1 week prior to and one day after surgery
Title
Nutritional status
Description
Lymphocyte count - Patients with <1,5 x 10E9/L 32 were considered to be at risk of malnutrition
Time Frame
At inclusion, 1 week prior to and one day after surgery
Title
Nutritional status
Description
D-Vitamin - Patients with 25OHD concentration < 50 nmol/L were defined as having a deficiency
Time Frame
At inclusion, 1 week prior to and one day after surgery
Title
Smoking
Description
Information of smoking habits were acquired through a questionnaire and divided into those that had quit smoking more than a year ago >than 6 months ago, >6 weeks ago, less than 6 weeks ago and current smokers
Time Frame
At inclusion, 1 week prior to surgery
Title
Physical activity
Description
Information of amount of weekly physical activity was acquired through a questionnaire and divided into two classes, zero to two times per week and three to five times per week. Each occasion was graded from 1 to more than 60 minutes.
Time Frame
At inclusion, 1 week prior to surgery
Title
Other postoperative complications
Description
Information from health records
Time Frame
up to two years postoperatively
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
All adult patients undergoing elective primary arthroplasty of either hip or knee at Landspitali University Hospital
Exclusion Criteria:
Contraindications for operation detected after inclusion. Patients having an operation on another joint within the inclusion period were not re-included.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sigurbergur Karason, Professor
Organizational Affiliation
Landspitali University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Landspitali University Hsopital
City
Reykjavik
State/Province
Hringbraut
ZIP/Postal Code
108
Country
Iceland
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Upon reasonable request
IPD Sharing Time Frame
After publication and 10 years afterwards
IPD Sharing Access Criteria
Upon reasonable request
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Arthroplasty and Modifiable Risk Factors
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