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

Not Applicable

Withdrawn

• Conditions: Osteoarthritis, Knee; Osteoarthritis, Hip
• Interventions: Behavioral: Risk Status Optimization

• Registration Number: NCT04087304
• Lead Sponsor: Rush University Medical Center

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-10-18
• Study First Submitted: 2019-09-09
• Study First Submitted QC: 2019-09-10
• Study First Posted: 2019-09-12
• Status Verified: 2022-10
• Primary Completion: 2022-10-25
• Study Completion: 2022-10-25
• Last Update Submitted: 2022-10-25
• Last Update Posted: 2022-10-27

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. Patients must be male or female of any race.
2. Patients much be age greater than 18 years old.
3. Patients undergoing a primary total hip arthroplasty (THA) or total knee arthroplasty (TKA) by participating surgeons at this institution.

Exclusion Criteria

1. Patients with history of native joint infection or active periprosthetic infection according to Musculoskeletal Infection Society (MSIS) Criteria.
2. Patients requiring removal of hardware during their primary total hip arthroplasty (THA) or total knee arthroplasty (TKA).
3. Patients requiring use of revision THA or TKA components (stems, augments).
4. Patients with history of neuromuscular disorder impairing ability to participate in standard postoperative rehabilitation protocol

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
High Risk Group	Risk Status Optimization	-
Moderate Risk Group	Risk Status Optimization	-

Primary Outcome Measures

Name	Time	Method
Optimized Risk Factors	Optimization time period covers a total time period of 6 months.	A Scoring System Questionnaire with risk factors associated with increased risk of complications in patients undergoing total hip and knee arthroplasty will be collected; Risk factors collected include obesity, drug allergies, presence of osteophytes, soft tissue to patella thickness, flexion contracture, diabetes, chronic opioid use, co-morbidities, prior knee surgeries, etiology of arthritis, smoking status, and reported disability. Each are measured on a scale of -5 to 10, with 10 being the best outcome. All the risk factors are added together and that comprises the total score.

Trial Locations

Locations (1)

Rush University Medical Center; 🇺🇸 Chicago, Illinois, United States