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

Primary Purpose

Hip Dysplasia, Cerebral Palsy

Status
Withdrawn
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Proximal Femoral Resection Arthroplasty
Subtrochanteric Valgus Osteotomy
Sponsored by
Hospital for Special Surgery, New York
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hip Dysplasia focused on measuring cerebral palsy, randomized controlled trial, hip dislocation, hip subluxation, patient centered outcomes, cost effectiveness analysis

Eligibility Criteria

7 Years - 21 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 7-21 years of age
  • Painful irreducible Hip dislocation and cerebral palsy diagnosis
  • GMFCS 4 or 5

Exclusion Criteria:

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

Sites / Locations

  • Phoenix Children's Hospital
  • Miami Children's Hospital
  • Boston Children's Hospital
  • Children's Hospital of Michigan
  • Hospital for Special Surgery
  • British Columbia Children's Hospital
  • The Hospital for Sick Children

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Proximal Femoral Resection Arthroplasty

Subtrochanteric Valgus Osteotomy

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Change in Quality of Life and Caregiver Burden
Measured by CPCHILD.

Secondary Outcome Measures

Mean Hip Migration
X-rays measuring hip migration will be standardized to anteroposterior (AP) Pelvis and Frog lateral. Patient positioning will be standardized according to normal clinical practice.
Pain Scores
NCCPC-R, PROMIS Pediatric Pain Interference, PROMIS Pediatric Pain Intensity
Caregiver Burden
Indirect Cost Form
Length of Stay
Discharge date - admission date. Transform into number of days. Length of stay can vary from days to weeks, if serious complication occurs.
Sitting Tolerance
Measured by wheelchair pressure mapping (hours /wk)
Range of Motion
Measured by goniometer (degrees)
Complications
Infection, deep vein thrombosis (DVT), fracture, heterotropic calcification
Function
Measured by GMFCS.
Splint
Need for splint or cast will be documented in medical records.
Secondary Surgery
Need for secondary surgery will be documented in medical records.
Standing Tolerance
Measured by instander (hours/ week)
Medical Costs
analyze claims data (approx 4 years)
Operative Outcomes
radiation, total time during surgery, skin dose, blood loss, surgeon experience, hip resection technique

Full Information

First Posted
July 14, 2014
Last Updated
May 13, 2021
Sponsor
Hospital for Special Surgery, New York
Collaborators
Phoenix Children's Hospital, The Hospital for Sick Children, Boston Children's Hospital, Children's Hospital of Michigan, British Columbia Children's Hospital, Nicklaus Children's Hospital f/k/a Miami Children's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02259140
Brief Title
A Randomized Control Trial of Hip Dislocation Techniques for Pediatric Patients With Cerebral Palsy
Official Title
ORCHID: Osteotomy vs Resection in CP Hip for Irreducible Dislocations: A Randomized Controlled Trial Comparing McHale to Castle Techniques
Study Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Withdrawn
Why Stopped
No patients have been enrolled since 2015. There has been difficulty recruiting patients for randomization. We have initiated a prospective cohort study evaluating salvage hip procedures for patients with cerebral palsy.
Study Start Date
October 2015 (undefined)
Primary Completion Date
September 2020 (Anticipated)
Study Completion Date
May 13, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospital for Special Surgery, New York
Collaborators
Phoenix Children's Hospital, The Hospital for Sick Children, Boston Children's Hospital, Children's Hospital of Michigan, British Columbia Children's Hospital, Nicklaus Children's Hospital f/k/a Miami Children's Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
The treatment of children with cerebral palsy (CP) with painful dislocated hips is a clinical challenge for the pediatric orthopedic surgeon. Although current regimens are based primarily on hip surveillance and early treatment of subluxation to avoid progression to dislocation, hip dislocations are still identified in the CP population. In younger children, in whom the hip is still of relatively normal morphology with intact cartilage and potential for remodeling (often identified by open tri-radiate cartilage) open hip reduction, varus rotational osteotomy and pelvic osteotomy may be a reasonable option. In older children, those with a deformed or damaged femoral head, those with closed triradiate cartilage, or in those with an irreducible hip, salvage options must be considered. Multiple techniques exist for treatment of irreducible painful hips in CP, including proximal femoral resection-interposition arthroplasty, resection at the femoral neck with subtrochanteric valgus osteotomy, hip replacement or hip arthrodesis (fusing the femur to the socket in a static position). This wide variation in practices is consistent with clinical uncertainty regarding the optimal treatment method for this problem. The most frequently performed intervention for a painful irreducible hip in the setting of CP is a form of resection arthroplasty, either alone (proximal femoral resection-interposition arthroplasty) or in conjunction with valgus support osteotomy. Technique selection is based on the functional level of the patient, patient symptoms, and surgeon preference.{{257 Van Riet,A. 2009; 253 Wright,P.B. 2013}} Although outcomes of resection at the femoral neck with subtrochanteric valgus osteotomy and proximal femoral resection-interposition arthroplasty techniques exist, published reports are retrospective non-randomized small series, which may be at risk for selection bias, and do not adequately capture all of the outcomes of interest, depending on what data has been routinely collected and documented in the medical chart.{{253 Wright,P.B. 2013; 259 Leet,A.I. 2005}},{{252 Boldingh,E.J. 2013}} Furthermore, results from these studies may be influenced by confounding factors, such as differences in patient age and other inequalities between groups at the time of surgery.{{252 Boldingh,E.J. 2013; 253 Wright,P.B. 2013; 277 Settecerri,J.J. 2000}} To the investigators knowledge, no prospective randomized comparison of hip resection techniques has been published accurately assessing child and parent quality of life, hip migration, or taking into account sitting and standing tolerance, pain, or hospital length of stay. Operative measures such as surgical time, blood loss and radiation exposure from intra-operative fluoroscopy have not previously been compared in a prospective manner. This study was designed as a multicenter randomized trial to answer an important clinical question about a rare condition, and to do so with a clearly defined objective and validated set of outcomes. This simple trial can be executed on a relatively small budget with simple outcome measures, and recruitment of a small number of patients at each of a few centers well equipped for research. By involving multiple surgeons and patients from various geographies, we improve the generalizability of this study. Our institution and collaborating institutions have been successful in completing randomized clinical trials in the past. This study will answer a clinical question that is important and current, providing orthopedic surgeons with an evidence-based answer: the optimal technique in treating painful irreducible hip dislocation in patients with cerebral palsy. The proposed research study aims to fill these gaps.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hip Dysplasia, Cerebral Palsy
Keywords
cerebral palsy, randomized controlled trial, hip dislocation, hip subluxation, patient centered outcomes, cost effectiveness analysis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Proximal Femoral Resection Arthroplasty
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Subtrochanteric Valgus Osteotomy
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Proximal Femoral Resection Arthroplasty
Other Intervention Name(s)
Castle Technique
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Subtrochanteric Valgus Osteotomy
Other Intervention Name(s)
McHale Technique
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Quality of Life and Caregiver Burden
Description
Measured by CPCHILD.
Time Frame
Baseline, 2-6 weeks, 5-7 months, 11-13 months and 23-25 months
Secondary Outcome Measure Information:
Title
Mean Hip Migration
Description
X-rays measuring hip migration will be standardized to anteroposterior (AP) Pelvis and Frog lateral. Patient positioning will be standardized according to normal clinical practice.
Time Frame
Baseline, post-operative, 2-6 weeks, 5-7 months, 11-13 months and 23-25 months
Title
Pain Scores
Description
NCCPC-R, PROMIS Pediatric Pain Interference, PROMIS Pediatric Pain Intensity
Time Frame
Baseline, 2-6 weeks, 5-7 months, 11-13 months and 23-25 months
Title
Caregiver Burden
Description
Indirect Cost Form
Time Frame
Baseline, 2-6 weeks, 5-7 months, 11-13 months and 23-25 months
Title
Length of Stay
Description
Discharge date - admission date. Transform into number of days. Length of stay can vary from days to weeks, if serious complication occurs.
Time Frame
An expected average of 5 days
Title
Sitting Tolerance
Description
Measured by wheelchair pressure mapping (hours /wk)
Time Frame
Baseline, 2-6 weeks, 5-7 months, 11-13 months and 23-25 months
Title
Range of Motion
Description
Measured by goniometer (degrees)
Time Frame
Baseline, 2-6 weeks, 5-7 months, 11-13 months and 23-25 months
Title
Complications
Description
Infection, deep vein thrombosis (DVT), fracture, heterotropic calcification
Time Frame
Baseline, 2-6 weeks, 5-7 months, 11-13 months and 23-25 months
Title
Function
Description
Measured by GMFCS.
Time Frame
Baseline, 2-6 weeks, 5-7 months, 11-13 months and 23-25 months
Title
Splint
Description
Need for splint or cast will be documented in medical records.
Time Frame
Baseline, 2-6 weeks, 5-7 months, 11-13 months and 23-25 months
Title
Secondary Surgery
Description
Need for secondary surgery will be documented in medical records.
Time Frame
Baseline, 2-6 weeks, 5-7 months, 11-13 months and 23-25 months
Title
Standing Tolerance
Description
Measured by instander (hours/ week)
Time Frame
Baseline, 2-6 weeks, 5-7 months, 11-13 months and 23-25 months
Title
Medical Costs
Description
analyze claims data (approx 4 years)
Time Frame
4 years (end of study)
Title
Operative Outcomes
Description
radiation, total time during surgery, skin dose, blood loss, surgeon experience, hip resection technique
Time Frame
intra-operative

10. Eligibility

Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 7-21 years of age Painful irreducible Hip dislocation and cerebral palsy diagnosis GMFCS 4 or 5 Exclusion Criteria: GMFCS 1-3 Decline to participate Outcome scales not validated in patient language. Candidate for total hip replacement
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Emily Dodwell, MD MPH FRCSC
Organizational Affiliation
Hospital for Special Surgery, New York
Official's Role
Principal Investigator
Facility Information:
Facility Name
Phoenix Children's Hospital
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85016
Country
United States
Facility Name
Miami Children's Hospital
City
Miami
State/Province
Florida
ZIP/Postal Code
33155
Country
United States
Facility Name
Boston Children's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Children's Hospital of Michigan
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
Hospital for Special Surgery
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
British Columbia Children's Hospital
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6H 3V4
Country
Canada
Facility Name
The Hospital for Sick Children
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G1X8
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
19492557
Citation
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.
Results Reference
background
PubMed Identifier
23752147
Citation
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.
Results Reference
background
PubMed Identifier
15614063
Citation
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.
Results Reference
background
PubMed Identifier
24025529
Citation
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.
Results Reference
background
PubMed Identifier
11097253
Citation
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.
Results Reference
background

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

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