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Should Graf IIc Hips be Treated for 12 Weeks

NCT03275805 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2025-07-15

No results posted yet for this study

Summary

Children who are diagnosed with Developmental Hip Dysplasia (DDH) are often categorized depending on the severity of their hip malformation. Regardless of the severity, the accepted form of treatment is the Pavlik Harness. Unfortunately, there is no specific recommended treatment regarding length of Pavlik Harness treatment for patients with DDH who have who have been categorized with stable Graf type IIc hips. The investigators will aim to answer this question with a randomized controlled trial of patients with these specific findings by dividing selected patients into 2 arms. Each arm consists of varying lengths of Pavlik harness treatment (treatment to normalization, no less than 6 weeks or 12 weeks full-time). Patient's two year follow up radiographs will determine the best means of treatment.

Conditions

  • Developmental Dysplasia of Hip

Interventions

OTHER

Duration of Pavlik Harness treatment

The only intervention that varies from standard of care (12 weeks of treatment) will be the duration of bracing (for the treatment to normalization arm). Patients in both arms will have identical follow up protocols and imaging to closely monitor hip morphology.

OTHER

12 week standard of care

The intervention for this arm will be standard treatment for this pathology.

Sponsors & Collaborators

  • University of Colorado, Denver

    lead OTHER

Principal Investigators

  • Gaia Georgopoulos, MD · Children's Hospital Colorado

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
0 Weeks
Max Age
18 Weeks
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-06-11
Primary Completion
2024-08-21
Completion
2025-07-01

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03275805 on ClinicalTrials.gov