Should Graf IIc Hips be Treated for 12 Weeks

NCT03275805 | Terminated

• 1 other identifier: 20-3104
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

DDH; Pavlik Harness; dysplasia

Outcome Measures

Primary Outcomes (1)

• Acetabular Index at 2 years

  AI is a categorical measure that can be calculated on routine radiographs (X-rays). This measure helps clinicians get an overall view of the patient hip morphology and illustrates the effectiveness of Pavlik treatment by revealing the placement of the femoral head within the acetabulum (hip socket). AI is expressed as a horizontal line connecting Hilgenreiner's line to another line connecting the acetabular roofs.

  2 year follow up

Other Outcomes (1)

• Cost of Treatment

  After conclusion of the 2 year follow up

Study Arms (2)

12 weeks Pavlik Treatment Arm

ACTIVE COMPARATOR

This arm will receive 12 weeks of full-time Pavlik Harness treatment. Patients will most likely begin the 12-week regiment at their first visit to our hip clinic.

Other: 12 week standard of care

6 weeks Pavlik Treatment Arm

EXPERIMENTAL

This arm will receive treatment to normalization, but for no less than 6 weeks. Patients will begin their treatment around the time of their first visit to our designated hip clinic.

Other: Duration of Pavlik Harness treatment

Interventions

Duration of Pavlik Harness treatment OTHER

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.

6 weeks Pavlik Treatment Arm

12 week standard of care OTHER

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

12 weeks Pavlik Treatment Arm

Eligibility Criteria

• Age: 0 Weeks - 18 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• \. Patients with:
• DDH
• Graf IIc hips (alpha angle = 43-49 degrees)
• normal hip exam (stable hips)
• abnormal ultrasound

You may not qualify if:

• Patients with additional conditions: Neurologic or teratologic.
• Follow up that occurs at any other institution.
• Unstable hips

Sponsors & Collaborators

• University of Colorado, Denver: lead

Study Sites (1)

Children's Hospital Colorado

Aurora, Colorado, 80045, United States

Location

Related Publications (23)

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MeSH Terms

Conditions

Hip Dislocation

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Joint Dislocations; Joint Diseases; Musculoskeletal Diseases; Wounds and Injuries; Hip Injuries

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Gaia Georgopoulos, MD

  Children's Hospital Colorado

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 21, 2016
• First Posted: September 8, 2017
• Study Start: June 11, 2021
• Primary Completion: August 21, 2024
• Study Completion: July 1, 2025
• Last Updated: July 15, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)