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

Cerebral Palsy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02259140
• Other study ID #: 2014-199
• Status: Withdrawn
• Phase: N/A
• Start date: October 2015
• Est. completion date: May 13, 2021

Study information

• Verified date: May 2021
• Source: Hospital for Special Surgery, New York
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: May 13, 2021
• Est. primary completion date: September 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 7 Years to 21 Years

Eligibility

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

Related Conditions & MeSH terms

• Cerebral Palsy
• Hip Dislocation
• Hip Dislocation, Congenital
• Hip Dysplasia

Intervention

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.
• 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.

Locations

Country	Name	City	State
Canada	The Hospital for Sick Children	Toronto	Ontario
Canada	British Columbia Children's Hospital	Vancouver	British Columbia
United States	Boston Children's Hospital	Boston	Massachusetts
United States	Children's Hospital of Michigan	Detroit	Michigan
United States	Miami Children's Hospital	Miami	Florida
United States	Hospital for Special Surgery	New York	New York
United States	Phoenix Children's Hospital	Phoenix	Arizona

Sponsors (7)

Lead Sponsor	Collaborator
Hospital for Special Surgery, New York	Boston Children's Hospital, British Columbia Children's Hospital, Children's Hospital of Michigan, Nicklaus Children's Hospital f/k/a Miami Children's Hospital, Phoenix Children's Hospital, The Hospital for Sick Children

Countries where clinical trial is conducted

United States,  Canada, 

References & Publications (5)

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. Review. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Caregiver Burden	Indirect Cost Form	Baseline, 2-6 weeks, 5-7 months, 11-13 months and 23-25 months
Secondary	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
Secondary	Sitting Tolerance	Measured by wheelchair pressure mapping (hours /wk)	Baseline, 2-6 weeks, 5-7 months, 11-13 months and 23-25 months
Secondary	Range of Motion	Measured by goniometer (degrees)	Baseline, 2-6 weeks, 5-7 months, 11-13 months and 23-25 months
Secondary	Complications	Infection, deep vein thrombosis (DVT), fracture, heterotropic calcification	Baseline, 2-6 weeks, 5-7 months, 11-13 months and 23-25 months
Secondary	Function	Measured by GMFCS.	Baseline, 2-6 weeks, 5-7 months, 11-13 months and 23-25 months
Secondary	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	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
Secondary	Standing Tolerance	Measured by instander (hours/ week)	Baseline, 2-6 weeks, 5-7 months, 11-13 months and 23-25 months
Secondary	Medical Costs	analyze claims data (approx 4 years)	4 years (end of study)
Secondary	Operative Outcomes	radiation, total time during surgery, skin dose, blood loss, surgeon experience, hip resection technique	intra-operative