- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03275805
Should Graf IIc Hips be Treated for 12 Weeks
How Should Stable Graf Type IIc Hips be Treated With Pavlik Harness?
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Developmental Dysplasia of the Hip is a thoroughly researched and manageable disease if treated correctly. While the literature agrees that Pavlik Harness treatment is the best means of treatment, there is still a lack of research regarding those patients who have stable Graf type IIc hips. Graf's classification method outlines the severity of dysplasia with a categorical method based on physical exam and ultrasound findings with a range of I-IV given in increasing order of severity. There are recommendations for how to treat more severe forms, but there is no consensus among orthopedic surgeons on how to specifically treat type IIc hips who present with stable hips.
Patients ages (0-18 weeks) of age will be recruited who present with stable Graf type IIc hips that have normal exam and abnormal ultrasound. The investigator's designated hip clinic defines normal exam as Ortolani and Barlow negative hips. Alpha angle will be used to determine normalcy on ultrasound. Abnormal ultrasound will be defined as an alpha angle <60 degrees, and less than 50% coverage and is justification in the facility for entrance into our designated hip protocol.
Upon meeting inclusion/exclusion criteria, patients diagnosed with IIc hips will be placed in the harness around 6 weeks of age. Patient consents will ensue at their 6 week follow up and will randomly divide patients into one of two arms: one control group which will receive the standard 12 week full-time protocol for Pavlik Harness treatment used at the institution, and one experimental group which will receive full-time Pavlik Harness treatment until normalization, but for no less than 6 weeks. All patients will be required to follow up at week 1, 2, 3, 4, 6, 8, 10, and 12, then at 6 months, one year, and two years from the time of harness placement. Ultrasounds will take place at week 1, 2, 3, 4, 6, 8, 10 and 12 and 6 months; radiographs will be taken at patients 6 month, one year and two year follow ups due to ossification of the femoral head. Acetabular Index (AI) at two-year radiographs will be used as the primary outcome variable.
Patients in the 6 week arm will only cease treatment if ultrasound and physical exam findings are acceptable. If patients fail to have acceptable ultrasound findings at 6 weeks, then the associated complication/failure will be noted, patients will be ineligible for study inclusion, and will continue with treatment to ensure hip reduction.
At routine follow ups, providers will note patient alpha angles on ultrasound at weeks 1,2,3,4,6, 8, 10, and 12 weeks. Since infant hips mature and may not be as visible on ultrasound around 6 months of age, acetabular indices on radiographs will be taken to measure patient hips at 6 month, 1 year, and 2 year follow ups. These images will be analyzed from within EPIC after patient visits and data information will be stored in RedCAP until the remainder of the study. Demographic and clinical characteristics will be included through descriptive statistics. Non-inferiority testing between patient's 2 year AI findings will determine if 6 weeks of treatment is no less harmful in terms of incidences of residual dysplasia to that of 12 weeks of treatment. The specified non-inferiority margin will be 4 degrees. This is the chosen clinically accepted difference in AI between groups.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Reba L Salton, BS
- Phone Number: 7207770702
- Email: reba.salton@childrenscolorado.org
Study Contact Backup
- Name: Gaia Georgopoulos, MD
- Phone Number: 7207775571
- Email: gaia.georgopoulos@childrenscolorado.org
Study Locations
-
-
Colorado
-
Aurora, Colorado, United States, 80045
- Recruiting
- Children's Hospital Colorado
-
Contact:
- Reba L Salton
- Phone Number: 720-777-0702
- Email: reba.salton@childrenscolorado.org
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
1. Patients with:
- DDH
- Graf IIc hips (alpha angle = 43-49 degrees)
- normal hip exam (stable hips)
- abnormal ultrasound
Exclusion Criteria:
- Patients with additional conditions: Neurologic or teratologic.
- Follow up that occurs at any other institution.
- Unstable hips
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: 12 weeks Pavlik Treatment Arm
This arm will receive 12 weeks of full-time Pavlik Harness treatment.
Patients will most likely begin the 12-week regiment at their first visit to our hip clinic.
|
The intervention for this arm will be standard treatment for this pathology.
|
Experimental: 6 weeks Pavlik Treatment Arm
This arm will receive treatment to normalization, but for no less than 6 weeks.
Patients will begin their treatment around the time of their first visit to our designated hip clinic.
|
The only intervention that varies from standard of care (12 weeks of treatment) will be the duration of bracing (for the treatment to normalization arm).
Patients in both arms will have identical follow up protocols and imaging to closely monitor hip morphology.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Acetabular Index at 2 years
Time Frame: 2 year follow up
|
AI is a categorical measure that can be calculated on routine radiographs (X-rays).
This measure helps clinicians get an overall view of the patient hip morphology and illustrates the effectiveness of Pavlik treatment by revealing the placement of the femoral head within the acetabulum (hip socket).
AI is expressed as a horizontal line connecting Hilgenreiner's line to another line connecting the acetabular roofs.
|
2 year follow up
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cost of Treatment
Time Frame: After conclusion of the 2 year follow up
|
Patient charges for both arms will be collected and compared (physician, imaging, facility charges)
|
After conclusion of the 2 year follow up
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Gaia Georgopoulos, MD, Children's Hospital Colorado
Publications and helpful links
General Publications
- Bialik V, Bialik GM, Blazer S, Sujov P, Wiener F, Berant M. Developmental dysplasia of the hip: a new approach to incidence. Pediatrics. 1999 Jan;103(1):93-9. doi: 10.1542/peds.103.1.93.
- Dunn PM, Evans RE, Thearle MJ, Griffiths HE, Witherow PJ. Congenital dislocation of the hip: early and late diagnosis and management compared. Arch Dis Child. 1985 May;60(5):407-14. doi: 10.1136/adc.60.5.407.
- Harding MG, Harcke HT, Bowen JR, Guille JT, Glutting J. Management of dislocated hips with Pavlik harness treatment and ultrasound monitoring. J Pediatr Orthop. 1997 Mar-Apr;17(2):189-98. doi: 10.1097/00004694-199703000-00010.
- Herring JA. Conservative treatment of congenital dislocation of the hip in the newborn and infant. Clin Orthop Relat Res. 1992 Aug;(281):41-7.
- Lorente Molto FJ, Gregori AM, Casas LM, Perales VM. Three-year prospective study of developmental dysplasia of the hip at birth: should all dislocated or dislocatable hips be treated? J Pediatr Orthop. 2002 Sep-Oct;22(5):613-21.
- Mubarak S, Garfin S, Vance R, McKinnon B, Sutherland D. Pitfalls in the use of the Pavlik harness for treatment of congenital dysplasia, subluxation, and dislocation of the hip. J Bone Joint Surg Am. 1981 Oct;63(8):1239-48.
- Novais EN, Sanders J, Kestel LA, Carry PM, Meyers ML. Graf Type-IV Hips Have a Higher Risk of Residual Acetabular Dysplasia at 1 Year of Age Following Successful Pavlik Harness Treatment for Developmental Hip Dysplasia. J Pediatr Orthop. 2018 Nov/Dec;38(10):498-502. doi: 10.1097/BPO.0000000000000875.
- Paton RW, Hopgood PJ, Eccles K. Instability of the neonatal hip: the role of early or late splintage. Int Orthop. 2004 Oct;28(5):270-3. doi: 10.1007/s00264-004-0576-8. Epub 2004 Aug 12.
- Rosendahl K, Dezateux C, Fosse KR, Aase H, Aukland SM, Reigstad H, Alsaker T, Moster D, Lie RT, Markestad T. Immediate treatment versus sonographic surveillance for mild hip dysplasia in newborns. Pediatrics. 2010 Jan;125(1):e9-16. doi: 10.1542/peds.2009-0357. Epub 2009 Dec 21.
- Sewell MD, Rosendahl K, Eastwood DM. Developmental dysplasia of the hip. BMJ. 2009 Nov 24;339:b4454. doi: 10.1136/bmj.b4454. No abstract available.
- Takahashi I. Functional treatment of congenital dislocation of the hip using Pavlik harness (Riemenbugel). Nihon Seikeigeka Gakkai Zasshi. 1985 Nov;59(11):973-84.
- Westacott DJ, Mackay ND, Waton A, Webb MS, Henman P, Cooke SJ. Staged weaning versus immediate cessation of Pavlik harness treatment for developmental dysplasia of the hip. J Pediatr Orthop B. 2014 Mar;23(2):103-6. doi: 10.1097/BPB.0000000000000025.
- Wood MK, Conboy V, Benson MK. Does early treatment by abduction splintage improve the development of dysplastic but stable neonatal hips? J Pediatr Orthop. 2000 May-Jun;20(3):302-5.
- Atalar H, Sayli U, Yavuz OY, Uras I, Dogruel H. Indicators of successful use of the Pavlik harness in infants with developmental dysplasia of the hip. Int Orthop. 2007 Apr;31(2):145-50. doi: 10.1007/s00264-006-0097-8. Epub 2006 Apr 7.
- Viere RG, Birch JG, Herring JA, Roach JW, Johnston CE. Use of the Pavlik harness in congenital dislocation of the hip. An analysis of failures of treatment. J Bone Joint Surg Am. 1990 Feb;72(2):238-44.
- Lerman JA, Emans JB, Millis MB, Share J, Zurakowski D, Kasser JR. Early failure of Pavlik harness treatment for developmental hip dysplasia: clinical and ultrasound predictors. J Pediatr Orthop. 2001 May-Jun;21(3):348-53.
- Graf R. Classification of hip joint dysplasia by means of sonography. Arch Orthop Trauma Surg (1978). 1984;102(4):248-55. doi: 10.1007/BF00436138.
- Shorter D, Hong T, Osborn DA. Cochrane Review: Screening programmes for developmental dysplasia of the hip in newborn infants. Evid Based Child Health. 2013 Jan;8(1):11-54. doi: 10.1002/ebch.1891.
- Woolacott NF, Puhan MA, Steurer J, Kleijnen J. Ultrasonography in screening for developmental dysplasia of the hip in newborns: systematic review. BMJ. 2005 Jun 18;330(7505):1413. doi: 10.1136/bmj.38450.646088.E0. Epub 2005 Jun 1.
- Bracken J, Tran T, Ditchfield M. Developmental dysplasia of the hip: controversies and current concepts. J Paediatr Child Health. 2012 Nov;48(11):963-72; quiz 972-3. doi: 10.1111/j.1440-1754.2012.02601.x.
- Shipman SA, Helfand M, Moyer VA, Yawn BP. Screening for developmental dysplasia of the hip: a systematic literature review for the US Preventive Services Task Force. Pediatrics. 2006 Mar;117(3):e557-76. doi: 10.1542/peds.2005-1597.
- Patel H; Canadian Task Force on Preventive Health Care. Preventive health care, 2001 update: screening and management of developmental dysplasia of the hip in newborns. CMAJ. 2001 Jun 12;164(12):1669-77.
- Godley DR. Assessment, diagnosis, and treatment of developmental dysplasia of the hip. JAAPA. 2013 Mar;26(3):54-8. doi: 10.1097/01720610-201303000-00011. No abstract available.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20-3104
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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