Hip and Knee Scoring System to Predict Complication Rate and Candidacy for Total Hip and Knee Arthroplasty
Primary Purpose
Osteoarthritis, Knee, Osteoarthritis, Hip
Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Risk Status Optimization
Sponsored by
About this trial
This is an interventional screening trial for Osteoarthritis, Knee
Eligibility Criteria
Inclusion Criteria:
- Patients must be male or female of any race.
- Patients much be age greater than 18 years old.
- Patients undergoing a primary total hip arthroplasty (THA) or total knee arthroplasty (TKA) by participating surgeons at this institution.
Exclusion Criteria:
- Patients with history of native joint infection or active periprosthetic infection according to Musculoskeletal Infection Society (MSIS) Criteria.
- Patients requiring removal of hardware during their primary total hip arthroplasty (THA) or total knee arthroplasty (TKA).
- Patients requiring use of revision THA or TKA components (stems, augments).
- Patients with history of neuromuscular disorder impairing ability to participate in standard postoperative rehabilitation protocol
Sites / Locations
- Rush University Medical Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
No Intervention
No Intervention
Active Comparator
Active Comparator
Arm Label
Low Risk Group
Mild Risk Group
Moderate Risk Group
High Risk Group
Arm Description
Outcomes
Primary Outcome Measures
Optimized Risk Factors
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT04087304
First Posted
September 9, 2019
Last Updated
October 25, 2022
Sponsor
Rush University Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT04087304
Brief Title
Hip and Knee Scoring System to Predict Complication Rate and Candidacy for Total Hip and Knee Arthroplasty
Official Title
Prospective Validation of a Hip and Knee Scoring System to Predict Complication Rate and Candidacy for Total Hip and Knee Arthroplasty
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Withdrawn
Why Stopped
Study was never started, no participants enrolled. Study was closed at Rush
Study Start Date
October 18, 2018 (Actual)
Primary Completion Date
October 25, 2022 (Actual)
Study Completion Date
October 25, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rush University Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Knee, Osteoarthritis, Hip
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Outcomes Assessor
Allocation
Non-Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Low Risk Group
Arm Type
No Intervention
Arm Title
Mild Risk Group
Arm Type
No Intervention
Arm Title
Moderate Risk Group
Arm Type
Active Comparator
Arm Title
High Risk Group
Arm Type
Active Comparator
Intervention Type
Behavioral
Intervention Name(s)
Risk Status Optimization
Intervention Description
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.
Primary Outcome Measure Information:
Title
Optimized Risk Factors
Description
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.
Time Frame
Optimization time period covers a total time period of 6 months.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients must be male or female of any race.
Patients much be age greater than 18 years old.
Patients undergoing a primary total hip arthroplasty (THA) or total knee arthroplasty (TKA) by participating surgeons at this institution.
Exclusion Criteria:
Patients with history of native joint infection or active periprosthetic infection according to Musculoskeletal Infection Society (MSIS) Criteria.
Patients requiring removal of hardware during their primary total hip arthroplasty (THA) or total knee arthroplasty (TKA).
Patients requiring use of revision THA or TKA components (stems, augments).
Patients with history of neuromuscular disorder impairing ability to participate in standard postoperative rehabilitation protocol
Facility Information:
Facility Name
Rush University Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60608
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Hip and Knee Scoring System to Predict Complication Rate and Candidacy for Total Hip and Knee Arthroplasty
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