Long-term Outcomes of Complex Conversion Total Hip Arthroplasty
NCT Number: NCT06533020
Acronym: LOCC
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Arthroplasty Complications
Sponsor: University of North Carolina, Chapel Hill
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 210
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-07
Completion Date: 2027-07-31
Locations: University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, 27599, United States

Summary:
The purpose of the research study is to examine the long-term outcomes of complex and conversion total hip arthroplasty procedures. By means of both retrospective (chart review) and prospective (in-person clinic visits) radiographs and validated patient-reported outcome scores including the Hip Disability and Osteoarthritis Outcome Score (HOOS) and the Patient-Reported Outcomes Measurement Information System (PROMIS), the research team aims to collect, analyze, and summarize the outcome data. The outcomes of the follow-up appointment will be analyzed in comparison to previous findings over various intervals to assess changes over time, if data is available.

Primary Outcome Measures: PROMIS SF v1.1-Pain Interference 8a, The Patient-Reported Outcomes Measurement Information System (PROMIS) SF v1.1-Pain Interference 8a measures the amount of pain interference in daily life. Possible scores range from "not at all" (1) to "very much" (5), with higher scores indicating a worse outcome (more pain interference)., once during the 36-month total study duration, preferably during initial recruitment, but open to collection at any time during the study timeframe|PROMIS SF v2.0 - Physical Function 20a, The Patient-Reported Outcomes Measurement Information System (PROMIS) SF v2.0 - Physical Function 20a measures the level of individual physical function in daily life. Possible scores range from "without any difficulty" (1) to "unable to do" (5) and "not at all" (1) to "cannot do" (5), with higher scores indicating a worse outcome (less physical function ability)., once during the 36-month total study duration, preferably during initial recruitment, but open to collection at any time during the study timeframe|HOOS, The Hip Disability and Osteoarthritis Outcome Score (HOOS) measures an individual's feelings about their hip and how well they are able to do usual activities, based on symptoms, stiffness, pain, daily living function, sports and recreational activities function, and quality of life. Possible scores range from "never" (1) to "always" (5) and "none" (1) to "extreme" (5), with higher scores indicating a worse outcome., once during the 36-month total study duration, preferably during initial recruitment, but open to collection at any time during the study timeframe|Radiographic Findings, Standard radiographs of implanted hip to assess device efficacy and other potential anomalies. Collected during in-person clinic visits or from chart review if the patients have had hip radiographs at UNC in the past two years., once during the 36-month total study duration, preferably during screening for initial recruitment, but open to collection at any time during the study timeframe
Secondary Outcome Measures: Number of participants with comorbidities, Individual health statuses (as diagnosed and present in the electronic medical record (EMR) throughout patient lifespan) thought to complicate the surgical procedure and recovery. Retrospectively collected during chart review including 20 statuses such as Diabetes Mellitus, Autoimmune Disorders, Current Immunosuppression, Current Dialysis/End Stage Renal Disease (ESRD), Chronic Kidney Disease (I-III), Heart Failure, Coronary Artery Disease, etc., Up to 36-months total study duration|Number of participants with complications, Individual health events (as present in the EMR throughout patient lifespan) and risk factors complicating the surgical procedure and recovery. Retrospectively collected during chart review including several events such as Iatrogenic fracture, Bleeding (Blood Transfusion), Surgical Site Infection, THA Periprosthetic Fracture, Wound Complication, etc, and risk factors such as Hip surgery prior to THA, age \> 70, Drug/alcohol use, etc., Up to 36 months total study duration