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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02259140
Recruitment Status : Recruiting
First Posted : October 8, 2014
Last Update Posted : October 28, 2019
Sponsor:
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
Information provided by (Responsible Party):
Hospital for Special Surgery, New York

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.

Condition or disease Intervention/treatment Phase
Hip Dysplasia Cerebral Palsy Procedure: Proximal Femoral Resection Arthroplasty Procedure: Subtrochanteric Valgus Osteotomy Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 74 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: ORCHID: Osteotomy vs Resection in CP Hip for Irreducible Dislocations: A Randomized Controlled Trial Comparing McHale to Castle Techniques
Study Start Date : October 2015
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : June 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Proximal Femoral Resection Arthroplasty
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
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.
Other Name: Castle Technique

Experimental: Subtrochanteric Valgus Osteotomy
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
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.
Other Name: McHale Technique




Primary Outcome Measures :
  1. Change in Quality of Life and Caregiver Burden [ Time Frame: Baseline, 2-6 weeks, 5-7 months, 11-13 months and 23-25 months ]
    Measured by CPCHILD.


Secondary Outcome Measures :
  1. Mean Hip Migration [ Time Frame: Baseline, post-operative, 2-6 weeks, 5-7 months, 11-13 months and 23-25 months ]
    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.

  2. Pain Scores [ Time Frame: Baseline, 2-6 weeks, 5-7 months, 11-13 months and 23-25 months ]
    NCCPC-R, PROMIS Pediatric Pain Interference, PROMIS Pediatric Pain Intensity

  3. Caregiver Burden [ Time Frame: Baseline, 2-6 weeks, 5-7 months, 11-13 months and 23-25 months ]
    Indirect Cost Form

  4. Length of Stay [ Time Frame: An expected average of 5 days ]
    Discharge date - admission date. Transform into number of days. Length of stay can vary from days to weeks, if serious complication occurs.

  5. Sitting Tolerance [ Time Frame: Baseline, 2-6 weeks, 5-7 months, 11-13 months and 23-25 months ]
    Measured by wheelchair pressure mapping (hours /wk)

  6. Range of Motion [ Time Frame: Baseline, 2-6 weeks, 5-7 months, 11-13 months and 23-25 months ]
    Measured by goniometer (degrees)

  7. Complications [ Time Frame: Baseline, 2-6 weeks, 5-7 months, 11-13 months and 23-25 months ]
    Infection, deep vein thrombosis (DVT), fracture, heterotropic calcification

  8. Function [ Time Frame: Baseline, 2-6 weeks, 5-7 months, 11-13 months and 23-25 months ]
    Measured by GMFCS.

  9. Splint [ Time Frame: Baseline, 2-6 weeks, 5-7 months, 11-13 months and 23-25 months ]
    Need for splint or cast will be documented in medical records.

  10. Secondary Surgery [ Time Frame: Baseline, 2-6 weeks, 5-7 months, 11-13 months and 23-25 months ]
    Need for secondary surgery will be documented in medical records.

  11. Standing Tolerance [ Time Frame: Baseline, 2-6 weeks, 5-7 months, 11-13 months and 23-25 months ]
    Measured by instander (hours/ week)

  12. Medical Costs [ Time Frame: 4 years (end of study) ]
    analyze claims data (approx 4 years)

  13. Operative Outcomes [ Time Frame: intra-operative ]
    radiation, total time during surgery, skin dose, blood loss, surgeon experience, hip resection technique



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   7 Years to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02259140


Contacts
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Contact: Emily Dodwell, MD MPH FRCSC 212-606-1451 dodwelle@hss.edu
Contact: Roger Widmann, MD 212-606-1325 widmannr@hss.edu

Locations
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United States, Arizona
Phoenix Children's Hospital Not yet recruiting
Phoenix, Arizona, United States, 85016
Contact: Wade Shrader, MD    602-933-1000    mailto:mwshrader@phoenixchildrens.com   
Principal Investigator: Wade Shrader, MD         
United States, Florida
Miami Children's Hospital Not yet recruiting
Miami, Florida, United States, 33155
Contact: Kevin Horowitz, MD    305-662-8366      
Principal Investigator: Kevin Horowitz, MD         
United States, Massachusetts
Boston Children's Hospital Not yet recruiting
Boston, Massachusetts, United States, 02115
Contact: Benjamin Shore, MD    617-355-6021    (Benjamin.Shore@childrens.harvard.edu)   
Principal Investigator: Benjamin Shore, MD         
Sub-Investigator: Brian Snyder, MD, PhD         
United States, Michigan
Children's Hospital of Michigan Not yet recruiting
Detroit, Michigan, United States, 48201
Contact: Ira Zaltz, MD    248-280-8550    zaltzira@gmail.com   
Principal Investigator: Ira Zaltz, MD         
United States, New York
Hospital for Special Surgery Recruiting
New York, New York, United States, 10021
Contact: Emily Dodwell, MD MPH FRCSC    212-606-1451    dodwelle@hss.edu   
Principal Investigator: Emily Dodwell, MD MPH FRCSC         
Sub-Investigator: Roger Widmann, MD         
Sub-Investigator: Lisa Drefus, DPT         
Sub-Investigator: John Blanco, MD         
Sub-Investigator: Tara Mathews, PhD         
Sub-Investigator: Stephen Lyman, PhD         
Sub-Investigator: Lisa Ipp, MD         
Sub-Investigator: Shevaun Doyle, MD         
Sub-Investigator: David Scher, MD         
Canada, British Columbia
British Columbia Children's Hospital Not yet recruiting
Vancouver, British Columbia, Canada, V6H 3V4
Contact: Kishore Mulpuri, MBBS MS MHSc    604-875-3187    kmulpuri@cw.bc.ca   
Principal Investigator: Kishore Mulpuri, MBBS MHSc MS         
Canada, Ontario
The Hospital for Sick Children Not yet recruiting
Toronto, Ontario, Canada, M5G1X8
Contact: Unni Narayanan, MBBS MSc    416-813-6432    unni.narayanan@sickkids.ca   
Principal Investigator: Unni Narayanan, MBBS MSc         
Sponsors and Collaborators
Hospital for Special Surgery, New York
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
Investigators
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Principal Investigator: Emily Dodwell, MD MPH FRCSC Hospital for Special Surgery, New York
Publications:
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Responsible Party: Hospital for Special Surgery, New York
ClinicalTrials.gov Identifier: NCT02259140    
Other Study ID Numbers: 2014-199
First Posted: October 8, 2014    Key Record Dates
Last Update Posted: October 28, 2019
Last Verified: October 2019
Keywords provided by Hospital for Special Surgery, New York:
cerebral palsy
randomized controlled trial
hip dislocation
hip subluxation
patient centered outcomes
cost effectiveness analysis
Additional relevant MeSH terms:
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Joint Dislocations
Hip Dislocation
Hip Dislocation, Congenital
Cerebral Palsy
Nervous System Diseases
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases
Joint Diseases
Musculoskeletal Diseases
Wounds and Injuries
Hip Injuries
Musculoskeletal Abnormalities
Congenital Abnormalities