Identifying the patient, disease, surgical, and implant positional shift factors that predict outcomes following total shoulder arthroplasty
Identifying the patient, disease, surgical, and implant positional shift factors that predict outcomes following total shoulder arthroplasty
批准号:
10132992
负责人:
Eric T. Ricchetti
金额:
$20.21万
依托单位国家:
美国
项目类别:
财政年份:
2020
资助国家:
美国
项目状态:
已结题
起止时间:
2020-04-01 至 2023-03-31
关键词:
AddressAnalysis of CovarianceAnatomyArthritisClassificationClinicalClinical TrialsComplicationDiagnostic radiologic examinationDiseaseEvaluationFutureHealth StatusImplantInstitutionInterventionInvestigationJointsLeadLegal patentLiteratureMeasuresMedialMental HealthModelingModificationOperative Surgical ProceduresOsteolysisOutcomePainPatient Outcomes AssessmentsPatient SelectionPatientsPerioperativePositioning AttributePostoperative PeriodPredictive FactorProceduresProspective cohort studyRadiology SpecialtyReplacement ArthroplastyReportingRisk FactorsRotationShoulderTranslationsUnited StatesWorkX-Ray Computed Tomographybasecohortdesignfollow-upimproved outcomeopioid useoutcome predictionpatient subsetsprospectiveroutine imagingsubscapularis musclesurvivorship
中文摘要
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英文摘要
Project Summary—Abstract
While total shoulder arthroplasty (TSA) is the preferred surgical treatment for advanced glenohumeral arthritis,
a subset of patients does not experience improvement or sustains a complication. Mean TSA complication
rates have ranged from 10-17%, with glenoid component loosening reported as the most common long-term
complication of anatomic TSA and a common reason for revision surgery. While complications can lead to poor
clinical outcomes, multiple studies have also shown associations between baseline demographic, disease-
related and surgical factors, and clinical outcomes. Despite these prior studies, the factors associated with
poor short- and long-term clinical outcome after anatomic TSA are still not well understood, in part due to the
lack of large prospective cohort studies allowing for multivariable analysis. Our proposal’s objective is to
identify the factors associated with short- and longer-term clinical and radiographic outcomes following
anatomic TSA. Our approach will utilize two unique, prospective TSA cohorts ongoing at our institution to allow
for simultaneous investigation of short and longer-term clinical outcomes, as well as the relationship between
the two through the assessment of radiographic factors not possible with routine imaging: a larger cohort (over
1,200 projected cases) collecting baseline demographic, disease-related and surgical factors, together with 1
year clinical outcomes (Patient Cohort 1); and a smaller cohort (n=152) collecting CT imaging-based
measures, as well as minimum 5 year clinical outcomes (Patient Cohort 2). Specific Aim 1 will use Patent
Cohort 1 to identify the risk factors associated with short-term clinical outcomes at 1 year after primary
anatomic TSA. Specific Aim 2 will use Patient Cohort 2 to conduct exploratory analyses of the incremental
contribution of CT imaging-based radiologic factors to the prediction of longer-term clinical outcomes at
minimum 5 years after primary anatomic TSA, beyond that provided by the perioperative risk factors identified
in Specific Aim 1.
We expect to show that baseline mental health status, pre-operative opioid use, pre-operative Penn Shoulder
Score (PSS) or Single Assessment Numeric Evaluation (SANE) score, Walch classification, subscapularis
management, and implant position will independently associate with 1-year patient-reported outcomes (PSS,
SANE) after controlling for other demographic, disease-related, and surgical factors (Aim 1). We also anticipate
that after adjusting for the risk factors investigated in Aim 1, glenoid component shift (translation and/or
rotation) and central peg osteolysis at minimum 2 and/or 5 years post-operatively will associate with worse
patient-reported outcomes (PSS, SANE) at minimum 5 years, and that the pre-operative Walch classification
and joint line medialization and the presence of central peg osteolysis at minimum 2 years will associate with
composite glenoid component shift at minimum 5 years (Aim 2). Identifying significant risk factors that are
important to clinical outcomes following anatomic TSA would allow for the design of future prospective clinical
trial(s) to investigate modification of these factors either directly or indirectly through pre-operative intervention
or modification of surgical treatment and/or patient selection based on these factors, with the aim to improve
outcomes and survivorship following anatomic TSA.
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Identifying the patient, disease, surgical, and implant positional shift factors that predict outcomes following total shoulder arthroplasty
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批准号:10378597
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项目类别:
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资助金额:$24.13万
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财政年份:2020
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负责人:Eric T. Ricchetti
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依托单位:
海外基金