A Randomized Control Trial of Hip Dislocation Techniques for Pediatric Patients With Cerebral Palsy

Summary

This randomized controlled trial will compare proximal femoral resection-interposition arthroplasty to proximal femoral resection with subtrochanteric valgus osteotomy for the treatment of painful irreducible hip dislocation in patients with cerebral palsy. The primary outcome is quality of life and care giver burden measured by The Caregiver Priorities and Child Health Index of Life with Disabilities (CPCHILD) score at one year. Secondary outcomes will include pain (NCCPC-R, PROMIS pain intensity and PROMIS pain interference), function (mobility questions), complications and surgical parameters such as OR time and fluoroscopy time. A cost-effectiveness analysis will follow completion of the randomized controlled trial (RCT). The authors hypothesize that mean CPCHILD scores (measured at 1 year) will be significantly higher following the Subtrochanteric Valgus Osteotomy technique compared to Proximal Femoral Resection-Interposition Arthroplasty technique. Furthermore, the Proximal Femoral Resection-Interposition Arthroplasty technique will have a shorter length of hospital stay, shorter fluoroscopy and OR times and the Subtrochanteric Valgus Osteotomy will have longer sitting tolerance, less pain, smaller burden for caregivers, better health, and higher quality of life. Additionally the authors hypothesize that Subtrochanteric Valgus Osteotomy will be more expensive than Proximal Femoral Resection-Interposition Arthroplasty, due to the cost of the plate, longer operative time, longer length of stay, and blood loss, but Subtrochanteric Valgus Osteotomy will be preferred by patients due to less pain and better functional and quality of life outcomes.The results of this study are expected to improve outcomes for children with cerebral palsy with painful irreducible dislocated hips.

Conditions

• Hip Dysplasia
• Cerebral Palsy

Interventions

PROCEDURE

Proximal Femoral Resection Arthroplasty

Drains will be placed at the surgeon's discretion. Patients will be placed in skin traction on the operative side. Post-operative bracing or casting will be at the surgeon's discretion. All patients will receive standardized post-operative prophylactic radiation to minimize heterotopic ossification.

PROCEDURE

Subtrochanteric Valgus Osteotomy

Drains will be placed at the surgeon's discretion. Post-operative bracing or casting will be at the surgeon's discretion. All patients will receive standardized post-operative prophylactic radiation to minimize heterotopic ossification.

Sponsors & Collaborators

• Phoenix Children's Hospital

  collaborator OTHER

• The Hospital for Sick Children

  collaborator OTHER

• Boston Children's Hospital

  collaborator OTHER

• Children's Hospital of Michigan

  collaborator OTHER

• British Columbia Children's Hospital

  collaborator OTHER

• Nicklaus Children's Hospital f/k/a Miami Children's Hospital

  collaborator OTHER

• Hospital for Special Surgery, New York

  lead OTHER

Principal Investigators

• Emily Dodwell, MD MPH FRCSC · Hospital for Special Surgery, New York

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

7 Years

Max Age

21 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2015-10-31

Primary Completion

2020-09-30

Completion

2021-05-13

Countries

• United States
• Canada

Study Locations