Osteoarthritis, KneeNCT04087304
Hip and Knee Scoring System to Predict Complication Rate and Candidacy for Total Hip and Knee Arthroplasty
A study testing Risk Status Optimization in people with Osteoarthritis, Knee and Osteoarthritis, Hip, run by Rush University Medical Center at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteoarthritis, Knee, Osteoarthritis, Hip
- What is being tested?
- Risk Status Optimization
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Oct 2018to 25 Oct 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Rush University Medical Center
Chicago, Illinois, 60608
About this study
Official title: Prospective Validation of a Hip and Knee Scoring System to Predict Complication Rate and Candidacy for Total Hip and Knee Arthroplasty
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
- Being tested
- Risk Status Optimization
- Medical subject headings
- Osteoarthritis, Knee, Osteoarthritis, Hip
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Risk Status OptimizationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Low Risk Group | No intervention | Not described |
| Mild Risk Group | No intervention | Not described |
| Moderate Risk Group | Active comparator | Not described Receives: Behavioral: Risk Status Optimization |
| High Risk Group | Active comparator | Not described Receives: Behavioral: Risk Status Optimization |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Optimization time period covers a total time period of 6 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2019
- Study start18 Oct 2018
- Primary completion25 Oct 2022
- Study completion25 Oct 2022
Why it stopped: Study was never started, no participants enrolled. Study was closed at Rush
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis, KneeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rush University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Brett Levine, MD, Rush University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04087304
- Sponsor's protocol ID
- 18081101-IRB01
- Status last verified
- Oct 2022
- First submitted
- 9 Sep 2019
- Last updated
- 27 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Validation of a Hip and Knee Scoring System to Predict Complication Rate and Candidacy for Total Hip and Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT04087304
- Acronym / sponsor ID
- 18081101-IRB01
- Conditions
- Osteoarthritis, Knee, Osteoarthritis, Hip
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study was never started, no participants enrolled. Study was closed at Rush
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Rush University Medical CenterUniversity, hospital or other
- Study start
- 18 Oct 2018 (actual)
- Primary completion
- 25 Oct 2022 (actual)
- Study completion
- 25 Oct 2022 (actual)
- First posted
- 12 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Low Risk Group | No intervention | – |
| Mild Risk Group | No intervention | – |
| Moderate Risk Group | Active comparator | Behavioral: Risk Status Optimization |
| High Risk Group | Active comparator | Behavioral: Risk Status Optimization |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Risk Status OptimizationAssessment 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. | Behavioural | High Risk Group, Moderate Risk Group |
Primary outcome
Optimized Risk Factors
Time frame: 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.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Risk Status Optimization in people with Osteoarthritis, Knee and Osteoarthritis, Hip, run by Rush University Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 27 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Optimized Risk Factors (time frame: Optimization time period covers a total time period of 6 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2022.