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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

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 Summary:

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 seri
Sponsor: Hospital for Special Surgery, New York

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

Original Primary Outcome: Quality of Life and Caregiver Burden [ Time Frame: 1 year ]

Current Secondary Outcome:

• 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.
• 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
• Caregiver Burden [ Time Frame: Baseline, 2-6 weeks, 5-7 months, 11-13 months and 23-25 months ]
  Indirect Cost Form
• 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.
• 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)
• Range of Motion [ Time Frame: Baseline, 2-6 weeks, 5-7 months, 11-13 months and 23-25 months ]
  Measured by goniometer (degrees)
• 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
• Function [ Time Frame: Baseline, 2-6 weeks, 5-7 months, 11-13 months and 23-25 months ]
  Measured by GMFCS.
• 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.
• 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.
• Standing Tolerance [ Time Frame: Baseline, 2-6 weeks, 5-7 months, 11-13 months and 23-25 months ]
  Measured by instander (hours/ week)
• Medical Costs [ Time Frame: 4 years (end of study) ]
  analyze claims data (approx 4 years)
• Operative Outcomes [ Time Frame: intra-operative ]
  radiation, total time during surgery, skin dose, blood loss, surgeon experience, hip resection technique

Original Secondary Outcome:

• Hip Migration [ Time Frame: post-operative, 3 months, 6 months, 1 years, 2 years ]
  X-rays measuring hip migration will be standardized to AP Pelvis and Frog lateral. Patient positioning will be standardized according to normal clinical practice.
• Pain Scores [ Time Frame: Baseline, 2 weeks, 6 weeks, 3 months, 6 months, 1 year and 2 year. ]
  Measured by VAS and non-communicating children's pain checklist
• Quality of Life [ Time Frame: Baseline, 2 weeks, 6 weeks, 3 months, 6 months, 1 year, and 2 years ]
  Measured by CPQOL
• Function [ Time Frame: Baseline, 6 months, 1 year, 2 year ]
  Measured by PODCI
• Quality of Life and Caregiver Burden [ Time Frame: Baseline, 2 weeks, 6 weeks, 3 months, 6 months, 2 years ]
  Measured by CPCHILD
• Overall Health [ Time Frame: Baseline, 6 months,1 year, 2 years ]
  Measured by PROMIS.
• Function [ Time Frame: Baseline, 6 months, 1 year, 2 years ]
  Measured by PEDI scale.
• 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.
• Sitting Tolerance [ Time Frame: Baseline, 6 months, 1 years, 2 years ]
  Measured by wheelchair pressure mapping (hours /wk)
• Range of Motion [ Time Frame: Baseline, 2 weeks, 6 weeks, 3 months, 6 months, 1 year, 2 years ]
  Measured by goniometer (degrees)
• Complications [ Time Frame: 2 weeks, 6 weeks, 3 months, 6 months, 1 year, 2 years ]
  Infection, DVT, fracture, heterotropic calcification
• Function [ Time Frame: Baseline, 2 weeks, 6 weeks, 3 months, 6 months,1 year, 2 years ]
  Measured by GMFCS.
• Splint [ Time Frame: 2 weeks, 6 weeks, 3 months, 6 months, 1 year, 2 years ]
  Need for splint or cast will be documented in medical records.
• Secondary Surgery [ Time Frame: 2 weeks, 6 weeks, 3 months, 6 months, 1 year, 2 years ]
  Need for secondary surgery will be documented in medical records.
• Standing Tolerance [ Time Frame: Baseline, 6 months, 1 years, 2 years ]
  Measured by instander (hours/ week)
• Medical Costs [ Time Frame: 4 years (end of study) ]
  analyze claims data (approx 4 years)
• Operative Outcomes [ Time Frame: intra-operative ]
  radiation, total time during surgery, skin dose, blood loss, surgeon experience, hip resection technique

Information By: Hospital for Special Surgery, New York

Dates:
Date Received: July 14, 2014
Date Started: October 2015
Date Completion: June 2019
Last Updated: April 20, 2017
Last Verified: April 2017