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Hip and Knee Scoring System to Predict Complication Rate and Candidacy for Total Hip and Knee Arthroplasty

NCT04087304 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2022-10-27

No results posted yet for this study

Summary

This study is a prospective validation study of a new hip and knee replacement-specific questionnaire that can be used to predict postoperative complications. The purpose of this study is to confirm the validity of a new hip and knee scoring system to be used as a clinical tool to predict potential complication rates in patients undergoing total hip or knee replacement surgery. This scoring system aims to stratify patients into specific risk categories based a standardized calculated score. Patients will be evaluated on health risk factors and severity of disease on radiographic imaging prior to surgery, associated to higher complication rates following surgery. The hopeful anticipated result of this study is a prospective validation of the scoring system with both statistical and clinical significance in predicting postoperative complication rates in patients with moderate to high health risk,

This stratification system may prove meaningful by allowing these patients, especially those classified as High-Risk, to be incorporated into more appropriate healthcare bundle payment systems that account for their higher financial demands. Furthermore, the stratification may allow for preoperative counseling and a shift towards non-operative management, or surgeon-patient conversations regarding the need to modify a portion of their objective risks prior to surgical intervention. Predictive risk models such as the one presented in the current study will be essential tools as the number of total hip arthroplasty procedures performed each year continue to increase and both the numbers of procedures and associated complications impose a significant cost on the U.S. healthcare system.

Conditions

  • Osteoarthritis, Knee
  • Osteoarthritis, Hip

Interventions

BEHAVIORAL

Risk Status Optimization

Assessment of risk factors putting surgical candidates of total hip and knee arthroplasty at higher risk of complication, and promoting risk factor optimization, thereby decreasing associated risk.

Sponsors & Collaborators

  • Rush University Medical Center

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
SCREENING
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-10-18
Primary Completion
2022-10-25
Completion
2022-10-25

Countries

  • United States

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 NCT04087304 on ClinicalTrials.gov