Long-term Outcomes of Complex Conversion Total Hip Arthroplasty

NCT06533020 | Active Not Recruiting

• 1 other identifier: 24-1026
• Study Type: observational
• Target: 210
• Locations: 1 country
• Sites: 1

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.

Conditions

Arthroplasty Complications

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (2)

• Number of participants with comorbidities

  Up to 36-months total study duration

• Number of participants with complications

  Up to 36 months total study duration

Study Arms (2)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

UNC Orthopaedics

You may qualify if:

• 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

You may not qualify if:

• Less than 18 years of age
• Incarcerated status

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead

Study Sites (1)

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

Study Officials

• Alecia Rajesh

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

• Ishani Deliwala

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 24, 2024
• First Posted: August 1, 2024
• Study Start: October 6, 2024
• Primary Completion (Estimated): July 31, 2027
• Study Completion (Estimated): July 31, 2027
• Last Updated: December 9, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Beginning 9 and continuing 36 months following publication
• Access Criteria: Investigator has approved IRB, IEC REB and an executed data use/sharing agreement with UNC.

Locations

US (1)