Long-term Outcomes of Complex Conversion Total Hip Arthroplasty

Recruiting

• Conditions: Arthroplasty Complications

• Registration Number: NCT06533020
• Lead Sponsor: University of North Carolina, Chapel Hill

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-07-24
• Study First Submitted QC: 2024-07-29
• Study First Posted: 2024-08-01
• Status Verified: 2024-10
• Study Start: 2024-10-06
• Last Update Submitted: 2024-10-15
• Last Update Posted: 2024-10-17
• Primary Completion: 2027-07-31
• Study Completion: 2027-07-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 210

Inclusion Criteria

• Having undergone a conversion total hip arthroplasty (THA) more than five years ago or a complex THA more than ten years ago done by a UNC Health-affiliated physician
• Willingness to receive follow-up care from a UNC Health-affiliated physician or provide outcome data regarding this surgical intervention
• Able to speak and read English
• Able to consent to participation

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Exclusion Criteria

• Less than 18 years of age
• Incarcerated status

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
PROMIS SF v1.1-Pain Interference 8a	once during the 36-month total study duration, preferably during initial recruitment, but open to collection at any time during the study timeframe	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).
Radiographic Findings	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	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.
PROMIS SF v2.0 - Physical Function 20a	once during the 36-month total study duration, preferably during initial recruitment, but open to collection at any time during the study timeframe	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).
HOOS	once during the 36-month total study duration, preferably during initial recruitment, but open to collection at any time during the study timeframe	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.

Secondary Outcome Measures

Name	Time	Method
Number of participants with comorbidities	Up to 36-months total study duration	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.
Number of participants with complications	Up to 36 months total study duration	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.

Trial Locations

Locations (1)

University of North Carolina at Chapel Hill; 🇺🇸 Chapel Hill, North Carolina, United States