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Arthroplasty and Modifiable Risk Factors

NCT05399186 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1484

Last updated 2023-10-04

No results posted yet for this study

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

Interventions

OTHER

Early preoperative assessment and optimization

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

Sponsors & Collaborators

  • Landspitali University Hospital

    lead OTHER

Principal Investigators

  • Sigurbergur Karason, Professor · Landspitali University Hospital

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-08-20
Primary Completion
2022-12-31
Completion
2022-12-31

Countries

  • Iceland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05399186 on ClinicalTrials.gov