Long-term Outcomes of Complex Conversion Total Hip Arthroplasty (LOCC)

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Arthroplasty Complications

• Study Type: Observational
• Enrollment (Estimated): 210

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599
      • University of North Carolina at Chapel Hill

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

UNC Orthopaedics

Description

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

Exclusion Criteria:

• Less than 18 years of age
• Incarcerated status

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Complex Total Hip Arthroplasty; Participants who have undergone complex total hip arthroplasty within the last 10 years
Conversion Total Hip Arthroplasty; Participants who have undergone conversion total hip arthroplasty within the last 5 years

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University of North Carolina, Chapel Hill
• Investigators: Principal Investigator: Alecia Rajesh, University of North Carolina, Chapel Hill; Principal Investigator: Ishani Deliwala, University of North Carolina, Chapel Hill

Study record dates

Study Major Dates

• Study Start (Actual): October 6, 2024
• Primary Completion (Estimated): July 31, 2027
• Study Completion (Estimated): July 31, 2027

Study Registration Dates

• First Submitted: July 24, 2024
• First Submitted That Met QC Criteria: July 29, 2024
• First Posted (Actual): August 1, 2024

Study Record Updates

• Last Update Posted (Estimated): December 9, 2025
• Last Update Submitted That Met QC Criteria: December 5, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: 24-1026

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.
• IPD Sharing Time Frame: Beginning 9 and continuing 36 months following publication
• IPD Sharing Access Criteria: Investigator has approved IRB, IEC REB and an executed data use/sharing agreement with UNC.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No