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

Study Overview
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Brief Summary
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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
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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.

Official Title
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ORCHID: Osteotomy vs Resection in CP Hip for Irreducible Dislocations: A Randomized Controlled Trial Comparing McHale to Castle Techniques

Conditions
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Cerebral Palsy, Hip Dysplasia

Intervention / Treatment
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* Procedure: Proximal Femoral Resection Arthroplasty
* Procedure: Subtrochanteric Valgus Osteotomy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 7 Years
Maximum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Proximal Femoral Resection Arthroplasty<br>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<br>* 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.<br>* Other names: Castle Technique;|
| Experimental: Subtrochanteric Valgus Osteotomy<br>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<br>* 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.<br>* Other names: McHale Technique;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Baseline, post-operative, 2-6 weeks, 5-7 months, 11-13 months and 23-25 months | 
| Pain Scores | NCCPC-R, PROMIS Pediatric Pain Interference, PROMIS Pediatric Pain Intensity | Baseline, 2-6 weeks, 5-7 months, 11-13 months and 23-25 months | 
| Caregiver Burden | Indirect Cost Form | Baseline, 2-6 weeks, 5-7 months, 11-13 months and 23-25 months | 
| 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. | An expected average of 5 days | 
| Sitting Tolerance | Measured by wheelchair pressure mapping (hours /wk) | Baseline, 2-6 weeks, 5-7 months, 11-13 months and 23-25 months | 
| Range of Motion | Measured by goniometer (degrees) | Baseline, 2-6 weeks, 5-7 months, 11-13 months and 23-25 months | 
| Complications | Infection, deep vein thrombosis (DVT), fracture, heterotropic calcification | Baseline, 2-6 weeks, 5-7 months, 11-13 months and 23-25 months | 
| Function | Measured by GMFCS. | Baseline, 2-6 weeks, 5-7 months, 11-13 months and 23-25 months | 
| Splint | Need for splint or cast will be documented in medical records. | Baseline, 2-6 weeks, 5-7 months, 11-13 months and 23-25 months | 
| Secondary Surgery | Need for secondary surgery will be documented in medical records. | Baseline, 2-6 weeks, 5-7 months, 11-13 months and 23-25 months | 
| Standing Tolerance | Measured by instander (hours/ week) | Baseline, 2-6 weeks, 5-7 months, 11-13 months and 23-25 months | 
| Medical Costs | analyze claims data (approx 4 years) | 4 years (end of study) | 
| Operative Outcomes | radiation, total time during surgery, skin dose, blood loss, surgeon experience, hip resection technique | intra-operative | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cerebral palsy, randomized controlled trial, hip dislocation, hip subluxation, patient centered outcomes, cost effectiveness analysis