NCT02259140

Brief 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.

Trial Health

33
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Oct 2015

Longer than P75 for not_applicable

Geographic Reach
2 countries

7 active sites

Status
withdrawn

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 14, 2014

Completed
3 months until next milestone

First Posted

Study publicly available on registry

October 8, 2014

Completed
12 months until next milestone

Study Start

First participant enrolled

October 1, 2015

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2020

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 13, 2021

Completed
Last Updated

May 17, 2021

Status Verified

May 1, 2021

Enrollment Period

4.9 years

First QC Date

July 14, 2014

Last Update Submit

May 13, 2021

Conditions

Hip DysplasiaCerebral Palsy

Keywords

cerebral palsyrandomized controlled trialhip dislocationhip subluxationpatient centered outcomescost effectiveness analysis

Outcome Measures

Primary Outcomes (1)

  • Change in Quality of Life and Caregiver Burden

    Measured by CPCHILD.

    Baseline, 2-6 weeks, 5-7 months, 11-13 months and 23-25 months

Secondary Outcomes (13)

  • Mean Hip Migration

    Baseline, post-operative, 2-6 weeks, 5-7 months, 11-13 months and 23-25 months

  • Pain Scores

    Baseline, 2-6 weeks, 5-7 months, 11-13 months and 23-25 months

  • Caregiver Burden

    Baseline, 2-6 weeks, 5-7 months, 11-13 months and 23-25 months

  • Length of Stay

    An expected average of 5 days

  • Sitting Tolerance

    Baseline, 2-6 weeks, 5-7 months, 11-13 months and 23-25 months

  • +8 more secondary outcomes

Study Arms (2)

Proximal Femoral Resection Arthroplasty

ACTIVE COMPARATOR

A 10-12 cm direct lateral incision will be made distally from the greater trochanter. The abductors of the hip are detached with sharp dissection. A capsulotomy is performed. The femur is exposed in a supra-periosteal manner (2 cm distal to the lesser trochanter) at the level of the ischium; transverse osteotomy will then be performed. The joint capsule will be sutured to itself. The iliopsoas tendon and the abductor tendons are attached to the capsule. The quadriceps will be brought around the proximal femoral stump and sutured to medial tissues.

Procedure: Proximal Femoral Resection Arthroplasty

Subtrochanteric Valgus Osteotomy

EXPERIMENTAL

A 10-12 cm direct lateral incision will be made distally from the greater trochanter. The medial half of the abductors may be incised off the greater trochanter for repair. The femoral head is resected at the base of the neck. The ligamentum teres is incised off the head and preserved. A lateral closing wedge osteotomy is performed below the lesser trochanter. 3.5 or 4.5 5 hole locking/non-locking surgeon-contoured plate ( 45⁰) will be used to stabilize the osteotomy. Femoral torsion will be corrected. The psoas tendon will attach the ligamentum teres to the lesser trochanter. The anterior and posterior capsule is sutured together creating interposition tissue. If the ligamentum teres was sutured to the lesser trochanter, the capsule will not close, but will be covered by the psoas tendon.

Procedure: Subtrochanteric Valgus Osteotomy

Interventions

Proximal Femoral Resection ArthroplastyPROCEDURE

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.

Also known as: Castle Technique
Proximal Femoral Resection Arthroplasty
Subtrochanteric Valgus OsteotomyPROCEDURE

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.

Also known as: McHale Technique
Subtrochanteric Valgus Osteotomy

Eligibility Criteria

Age7 Years - 21 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • years of age
  • Painful irreducible Hip dislocation and cerebral palsy diagnosis
  • GMFCS 4 or 5

You may not qualify if:

  • GMFCS 1-3
  • Decline to participate
  • Outcome scales not validated in patient language.
  • Candidate for total hip replacement

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Phoenix Children's Hospital

Phoenix, Arizona, 85016, United States

Location

Miami Children's Hospital

Miami, Florida, 33155, United States

Location

Boston Children's Hospital

Boston, Massachusetts, 02115, United States

Location

Children's Hospital of Michigan

Detroit, Michigan, 48201, United States

Location

Hospital for Special Surgery

New York, New York, 10021, United States

Location

British Columbia Children's Hospital

Vancouver, British Columbia, V6H 3V4, Canada

Location

The Hospital for Sick Children

Toronto, Ontario, M5G1X8, Canada

Location

Related Publications (5)

  • Van Riet A, Moens P. The McHale procedure in the treatment of the painful chronically dislocated hip in adolescents and adults with cerebral palsy. Acta Orthop Belg. 2009 Apr;75(2):181-8.

    PMID: 19492557BACKGROUND

  • Wright PB, Ruder J, Birnbaum MA, Phillips JH, Herrera-Soto JA, Knapp DR. Outcomes after salvage procedures for the painful dislocated hip in cerebral palsy. J Pediatr Orthop. 2013 Jul-Aug;33(5):505-10. doi: 10.1097/BPO.0b013e3182924677.

    PMID: 23752147BACKGROUND

  • Leet AI, Chhor K, Launay F, Kier-York J, Sponseller PD. Femoral head resection for painful hip subluxation in cerebral palsy: Is valgus osteotomy in conjunction with femoral head resection preferable to proximal femoral head resection and traction? J Pediatr Orthop. 2005 Jan-Feb;25(1):70-3. doi: 10.1097/00004694-200501000-00016.

    PMID: 15614063BACKGROUND

  • Boldingh EJ, Bouwhuis CB, van der Heijden-Maessen HC, Bos CF, Lankhorst GJ. Palliative hip surgery in severe cerebral palsy: a systematic review. J Pediatr Orthop B. 2014 Jan;23(1):86-92. doi: 10.1097/BPB.0b013e3283651a5d.

    PMID: 24025529BACKGROUND

  • Settecerri JJ, Karol LA. Effectiveness of femoral varus osteotomy in patients with cerebral palsy. J Pediatr Orthop. 2000 Nov-Dec;20(6):776-80. doi: 10.1097/00004694-200011000-00015.

    PMID: 11097253BACKGROUND

MeSH Terms

Conditions

Hip DislocationCerebral Palsy

Condition Hierarchy (Ancestors)

Joint DislocationsJoint DiseasesMusculoskeletal DiseasesWounds and InjuriesHip InjuriesBrain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Emily Dodwell, MD MPH FRCSC

    Hospital for Special Surgery, New York

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 14, 2014

First Posted

October 8, 2014

Study Start

October 1, 2015

Primary Completion

September 1, 2020

Study Completion

May 13, 2021

Last Updated

May 17, 2021

Record last verified: 2021-05

Locations

US(5)CA(2)