NCT06891196

Brief Summary

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.

Trial Health

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Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 15, 2025

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 19, 2025

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 24, 2025

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2026

Completed
Last Updated

March 24, 2025

Status Verified

March 1, 2025

Enrollment Period

1 year

First QC Date

February 19, 2025

Last Update Submit

March 21, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Revision surgery

    Total number of patients who required revision surgery for pediatric hip conditions

    2 years

Secondary Outcomes (3)

  • Change in neck-shaft angle measurement

    Baseline, 2 years

  • Change in acetabular index

    Baseline, 2 years

  • Change in migration index

    Baseline, 2 years

Study Arms (1)

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.

Other: Long-term Follow-up Surveys

Interventions

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.

Pediatric patients with hip conditions

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients over the age of 18 seen for a concern of hip pathology at Mayo between 1975 and 2024.

You may qualify if:

  • 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.

You may not qualify if:

  • Patients presenting over age 18 for hip dysplasia
  • Patients who are unwilling to complete follow up surveys.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Hip Dislocation

Condition Hierarchy (Ancestors)

Joint DislocationsJoint DiseasesMusculoskeletal DiseasesWounds and InjuriesHip Injuries

Study Officials

  • Emmanouil Grigoriou, M.D.

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 19, 2025

First Posted

March 24, 2025

Study Start

January 15, 2025

Primary Completion

January 15, 2026

Study Completion

January 15, 2026

Last Updated

March 24, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations