Hip DysplasiaNCT02259140
A Randomized Control Trial of Hip Dislocation Techniques for Pediatric Patients With Cerebral Palsy
A study testing Proximal Femoral Resection Arthroplasty and Subtrochanteric Valgus Osteotomy in people with Hip Dysplasia and Cerebral Palsy, run by Hospital for Special Surgery, New York at 7 sites in 2 countries.
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. Read more about this study
- Who is it for?
- Ages 7 to 21 years
- Conditions the study is for
- Hip Dysplasia, Cerebral Palsy
- What is being tested?
- Proximal Femoral Resection Arthroplasty and Subtrochanteric Valgus Osteotomy
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 7 sitesin 2 countries
- Study dates
- Oct 2015to 13 May 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 7-21 years of age
- Painful irreducible Hip dislocation and cerebral palsy diagnosis
- GMFCS 4 or 5
Who cannot join
- GMFCS 1-3
- Decline to participate
- Outcome scales not validated in patient language.
- Candidate for total hip replacement
Trial locations and contacts
7 sites in 2 countries.
7 sites in 2 countries
United States5 sites
Boston Children's Hospital
Boston, Massachusetts, 02115
Children's Hospital of Michigan
Detroit, Michigan, 48201
Miami Children's Hospital
Miami, Florida, 33155
Hospital for Special Surgery
New York, New York, 10021
Phoenix Children's Hospital
Phoenix, Arizona, 85016
Canada2 sites
The Hospital for Sick Children
Toronto, Ontario, M5G1X8
British Columbia Children's Hospital
Vancouver, British Columbia, V6H 3V4
About this study
Official title: ORCHID: Osteotomy vs Resection in CP Hip for Irreducible Dislocations: A Randomized Controlled Trial Comparing McHale to Castle Techniques
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.
Read the 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.
- Conditions
- Hip Dysplasia, Cerebral Palsy
- Being tested
- Proximal Femoral Resection Arthroplasty, Subtrochanteric Valgus Osteotomy
- Keywords
- cerebral palsy, randomized controlled trial, hip dislocation, hip subluxation, patient centered outcomes, cost effectiveness analysis
- Medical subject headings
- Hip Dislocation, Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Proximal Femoral Resection ArthroplastyProcedure or surgery
Also called Castle Technique
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 OsteotomyProcedure or surgery
Also called McHale Technique
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.
| Study group | Role | What they receive |
|---|---|---|
| Proximal Femoral Resection Arthroplasty | Active comparator | 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. Receives: Procedure: Proximal Femoral Resection Arthroplasty |
| Subtrochanteric Valgus Osteotomy | Experimental | 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. Receives: Procedure: Subtrochanteric Valgus Osteotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Quality of Life and Caregiver Burden
Measured by CPCHILD.
Measured: Baseline, 2-6 weeks, 5-7 months, 11-13 months and 23-25 months
Secondary outcomes (13)
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.
Measured: 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
Measured: Baseline, 2-6 weeks, 5-7 months, 11-13 months and 23-25 months
Caregiver Burden
Indirect Cost Form
Measured: 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.
Measured: An expected average of 5 days
Sitting Tolerance
Measured by wheelchair pressure mapping (hours /wk)
Measured: Baseline, 2-6 weeks, 5-7 months, 11-13 months and 23-25 months
Range of Motion
Measured by goniometer (degrees)
Measured: Baseline, 2-6 weeks, 5-7 months, 11-13 months and 23-25 months
Complications
Infection, deep vein thrombosis (DVT), fracture, heterotropic calcification
Measured: Baseline, 2-6 weeks, 5-7 months, 11-13 months and 23-25 months
Function
Measured by GMFCS.
Measured: 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.
Measured: 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.
Measured: Baseline, 2-6 weeks, 5-7 months, 11-13 months and 23-25 months
Standing Tolerance
Measured by instander (hours/ week)
Measured: Baseline, 2-6 weeks, 5-7 months, 11-13 months and 23-25 months
Medical Costs
analyze claims data (approx 4 years)
Measured: 4 years (end of study)
Operative Outcomes
radiation, total time during surgery, skin dose, blood loss, surgeon experience, hip resection technique
Measured: intra-operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2014 (estimated)
- Study startOct 2015
- Primary completionSep 2020 (estimated)
- Study completion13 May 2021
Why it 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.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Hip DysplasiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital for Special Surgery, New York
- Sponsor type
- University, hospital or other
- 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
- Responsible party
- Sponsor
- Investigators
- Emily Dodwell, MD MPH FRCSC, Principal investigator, Hospital for Special Surgery, New York
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02259140
- Sponsor's protocol ID
- 2014-199
- Status last verified
- May 2021
- First submitted
- 14 Jul 2014
- Last updated
- 17 May 2021
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 19492557Wright 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.
PubMed 23752147Leet 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.
PubMed 15614063Boldingh 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.
PubMed 24025529Settecerri 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.
PubMed 11097253
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ORCHID: Osteotomy vs Resection in CP Hip for Irreducible Dislocations: A Randomized Controlled Trial Comparing McHale to Castle Techniques
- ClinicalTrials.gov ID
- NCT02259140
- Acronym / sponsor ID
- 2014-199
- Conditions
- Hip Dysplasia, Cerebral Palsy
- Keywords
- cerebral palsy, randomized controlled trial, hip dislocation, hip subluxation, patient centered outcomes, cost effectiveness analysis
- Study type
- Interventional
- Recruitment status
- WithdrawnReason 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.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Hospital for Special Surgery, New YorkUniversity, hospital or other
- 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
- Study start
- Oct 2015
- Primary completion
- Sep 2020 (estimated)
- Study completion
- 13 May 2021 (actual)
- First posted
- 8 Oct 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Proximal Femoral Resection Arthroplasty | Active comparator | Procedure: Proximal Femoral Resection ArthroplastyA 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. |
| Subtrochanteric Valgus Osteotomy | Experimental | Procedure: Subtrochanteric Valgus OsteotomyA 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. |
Who may qualify
- Ages
- 7 to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 7-21 years of age
- Painful irreducible Hip dislocation and cerebral palsy diagnosis
- GMFCS 4 or 5
Key exclusion criteria (4 listed)
- GMFCS 1-3
- Decline to participate
- Outcome scales not validated in patient language.
- Candidate for total hip replacement
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Proximal Femoral Resection ArthroplastyAlso: Castle TechniqueDrains 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. | Procedure or surgery | Proximal Femoral Resection Arthroplasty |
| Subtrochanteric Valgus OsteotomyAlso: McHale TechniqueDrains 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. | Procedure or surgery | Subtrochanteric Valgus Osteotomy |
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
Measured by CPCHILD.
13 secondary outcomes
Mean Hip Migration
Time frame: Baseline, post-operative, 2-6 weeks, 5-7 months, 11-13 months and 23-25 months
Pain Scores
Time frame: Baseline, 2-6 weeks, 5-7 months, 11-13 months and 23-25 months
Caregiver Burden
Time frame: Baseline, 2-6 weeks, 5-7 months, 11-13 months and 23-25 months
Length of Stay
Time frame: An expected average of 5 days
Sitting Tolerance
Time frame: Baseline, 2-6 weeks, 5-7 months, 11-13 months and 23-25 months
Range of Motion
Time frame: Baseline, 2-6 weeks, 5-7 months, 11-13 months and 23-25 months
Complications
Time frame: Baseline, 2-6 weeks, 5-7 months, 11-13 months and 23-25 months
Function
Time frame: Baseline, 2-6 weeks, 5-7 months, 11-13 months and 23-25 months
Splint
Time frame: Baseline, 2-6 weeks, 5-7 months, 11-13 months and 23-25 months
Secondary Surgery
Time frame: Baseline, 2-6 weeks, 5-7 months, 11-13 months and 23-25 months
Standing Tolerance
Time frame: Baseline, 2-6 weeks, 5-7 months, 11-13 months and 23-25 months
Medical Costs
Time frame: 4 years (end of study)
Operative Outcomes
Time frame: intra-operative
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2021.
- Background: PubMed 19492557Van 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.
- Background: PubMed 23752147Wright 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.
- Background: PubMed 15614063Leet 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.
- Background: PubMed 24025529Boldingh 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.
- Background: PubMed 11097253Settecerri 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Emily Dodwell, MD MPH FRCSC principal investigator
Hospital for Special Surgery, New York
7 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Proximal Femoral Resection Arthroplasty and Subtrochanteric Valgus Osteotomy in people with Hip Dysplasia and Cerebral Palsy, run by Hospital for Special Surgery, New York at 7 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 17 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Quality of Life and Caregiver Burden (time frame: Baseline, 2-6 weeks, 5-7 months, 11-13 months and 23-25 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02259140, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 May 2021.