- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06891196
Mixed-Methods Evaluation of Short-, Medium-, and Long-Term Outcomes Following Hip Treatment
Study Overview
Status
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Locations
-
-
Minnesota
-
Rochester, Minnesota, United States, 55905
- Mayo Clinic in Rochester
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
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. |
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Revision surgery
Time Frame: 2 years
|
Total number of patients who required revision surgery for pediatric hip conditions
|
2 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in neck-shaft angle measurement
Time Frame: Baseline, 2 years
|
Radiographic measurement of the neck-shaft angle
|
Baseline, 2 years
|
|
Change in acetabular index
Time Frame: Baseline, 2 years
|
Radiographic measurement of the acetabular index
|
Baseline, 2 years
|
|
Change in migration index
Time Frame: Baseline, 2 years
|
Radiographic measurement of the migration index
|
Baseline, 2 years
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Emmanouil Grigoriou, M.D., Mayo Clinic
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 24-012155
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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