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NCT04087304

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

Withdrawn NA Last updated 27 October 2022
What this trial tests

NA trial testing Risk Status Optimization in Osteoarthritis, Knee. Withdrawn.

Timeline
18 October 2018
Primary endpoint
25 October 2022
25 October 2022

Quick facts

Lead sponsorRush University Medical Center
PhaseNA
StatusWithdrawn
Study typeINTERVENTIONAL
Allocationnon randomized
Designcrossover
Maskingsingle
Primary purposescreening
Start date18 October 2018
Primary completion25 October 2022
Estimated completion25 October 2022
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Rush University Medical Center

Who can join

18 and older, any sex, with Osteoarthritis, Knee or Osteoarthritis, Hip. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

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Other recruiting trials for Osteoarthritis, Knee

Currently open trials in the same condition.

Other Rush University Medical Center trials

Trials by the same sponsor.

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04087304.

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