Mixed-Methods Evaluation of Short-, Medium-, and Long-Term Outcomes Following Hip Treatment

NCT ID: NCT06891196

Last Updated: 2025-03-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-01-15

Study Completion Date

2026-01-15

Brief Summary

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This study, titled "Mixed-Methods Evaluation of Short-, Medium-, and Long-Term Outcomes Following Hip Treatment," aims to assess the long-term effectiveness of treatments for pediatric hip conditions, including hip dysplasia, Legg-Calve-Perthes disease, SCFE, and avascular necrosis.

Detailed Description

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Conducted at Mayo Clinic, the study combines retrospective chart reviews and prospective follow-up to gather data on clinical outcomes, radiographic measures, and patient-reported outcomes (PROs) like functional status, pain, and quality of life.

The retrospective component analyzes records from 1975 to 2024, while the prospective component includes follow-up surveys using validated PRO measures (e.g., HOOS, SF-12, VAS). This study seeks to identify recurrence rates and complications associated with hip treatments, providing insights to improve future care standards for pediatric hip conditions. Data will be securely stored, with confidentiality maintained throughout.

Conditions

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Hip Dysplasia Legg-Calvâe-Perthes Disease Avascular Necrosis of Hip

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Pediatric patients with hip conditions

Medical records and radiographs of patients who were treated for hip conditions at Mayo Clinic from 1975 to 2022 will be included in a retrospective chart review. Radiographic evaluations will include measurements of the neck-shaft angle, acetabular index, migration index, and other commonly used metrics.

The prospective follow-up will include a subset of patients from the retrospective review, who will be complete long-term follow-up surveys.

Long-term Follow-up Surveys

Intervention Type OTHER

Patients will be given surveys, including validated PRO measures such as the Hip Disability and Osteoarthritis Outcomes Score (HOOS), Short-Form 12 (SF-12), Visual Analog Scale (VAS) for pain, and Marx activity scores.

Interventions

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Long-term Follow-up Surveys

Patients will be given surveys, including validated PRO measures such as the Hip Disability and Osteoarthritis Outcomes Score (HOOS), Short-Form 12 (SF-12), Visual Analog Scale (VAS) for pain, and Marx activity scores.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Patients over the age of 18 seen for a concern of hip pathology at Mayo between 1975 and 2024
* Patients over 18 who can be contacted for follow-up and are willing to participate.

Exclusion Criteria

* Patients presenting over age 18 for hip dysplasia
* Patients who are unwilling to complete follow up surveys.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

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Emmanouil Grigoriou

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Emmanouil Grigoriou, M.D.

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

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Mayo Clinic in Rochester

Rochester, Minnesota, United States

Site Status

Countries

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United States

Other Identifiers

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24-012155

Identifier Type: -

Identifier Source: org_study_id

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