Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT06533020

Long-term Outcomes of Complex Conversion Total Hip Arthroplasty

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Arthroplasty Complications

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. PROMIS SF v1.1-Pain Interference 8a

    Time frame: 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).

  2. PROMIS SF v2.0 - Physical Function 20a

    Time frame: 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).

  3. HOOS

    Time frame: 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.

  4. Radiographic Findings

    Time frame: 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.

Secondary outcomes

  1. Number of participants with comorbidities

    Time frame: 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.

  2. Number of participants with complications

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of North Carolina, Chapel Hill

Other

Registry information

Acronym: LOCC

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Aug 1, 2024
Registry last updated
Dec 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.