Arthroplasty and Modifiable Risk Factors

NCT05399186 | Completed

• 1 other identifier: 20220508
• Study Type: interventional
• Target: 1,484
• Locations: 1 country
• Sites: 1

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.

Conditions

Total Joint Arthroplasty; Risk Reduction; Surgical Site Infection; Prosthetic-joint Infection; Postoperative Complications

Outcome Measures

Primary Outcomes (4)

• Number of Participants with Surgical site infection

  Evaluated according to CDC's National Healthcare Safety Network

  6 weeks postoperatively

• Number of Participants with Surgical site infection

  Evaluated according to CDC's National Healthcare Safety Network

  2 years postoperatively

• Number of Participants with Prosthetic joint infection

  Evaluated according to CDC's National Healthcare Safety Network

  6 weeks postoperatively

• Number of Participants with Prosthetic joint infection

  Evaluated according to CDC's National Healthcare Safety Network

  2 years postoperatively

Secondary Outcomes (9)

• Preoperative anemia according to WHO's definition

  At inclusion, 1 week prior to and one day after surgery

• Control of diabetes

  At inclusion, 1 week prior to and one day after surgery

• Indication of poor glucose control

  At inclusion, 1 week prior to and one day after surgery

• Nutritional status

  At inclusion, 1 week prior to and one day after surgery

• Nutritional status

  At inclusion, 1 week prior to and one day after surgery

Study Arms (2)

Control group

NO INTERVENTION

Usual care group - receiving traditional preoperative preparation and assessment (1 week) prior to total joint arthroplastic surgery

Early preoperative assessment and optimization

EXPERIMENTAL

Interventional group - receiving early preoperative assessment and optimization (6-12 months) in wait of total joint arthroplastic surgery

Other: Early preoperative assessment and optimization

Interventions

Early preoperative assessment and optimization OTHER

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

Early preoperative assessment and optimization

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All adult patients undergoing elective primary arthroplasty of either hip or knee at Landspitali University Hospital

Sponsors & Collaborators

• Landspitali University Hospital: lead

Study Sites (1)

Landspitali University Hsopital

Reykjavik, Hringbraut, 108, Iceland

Location

MeSH Terms

Conditions

Risk Reduction Behavior; Surgical Wound Infection; Postoperative Complications

Condition Hierarchy (Ancestors)

Behavior; Wound Infection; Infections; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Sigurbergur Karason, Professor

  Landspitali University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: A prospective non-randomized quality control study before and after an intervention regarding preoperative preparation for total joint arthroplasty

Study Record Dates

• First Submitted: May 19, 2022
• First Posted: June 1, 2022
• Study Start: August 20, 2018
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: October 4, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: After publication and 10 years afterwards
• Access Criteria: Upon reasonable request

Locations

IC (1)