Investigation of the Femoral Shortening Osteotomy in the Developmental Dislocation of the Hip (FSODDH) (FSODDH)

Investigation of the Value of Femoral Shortening Osteotomy During Open Treatment of Developmental Dislocation of the Hip in Waliking Age Group

Although older children and high dislocations may be more likely to require a femoral shortening osteotomy, the ultimate decision about whether or not to shorten a given femur should depend on the ease of femoral head reduction in that specific patient. Adding a femoral shortening procedure increases operating time and blood loss, adds a second incision, and necessitates future hardware removal. In addition, an unnecessary femoral shortening osteotomy could overly decrease the soft tissue tension around the joint, putting the hip at risk for redislocation. This study was designed to explore an algorithm based on strict age and radiographic criteria that identify those without the need of femoral osteotomy.

Study Overview

• Status: Unknown
• Conditions: Femur Head Necrosis; Hip Dislocation
• Intervention / Treatment: Procedure: Osteotomy; Procedure: Non-osteotomy

Detailed Description

Developmental dislocation of the hip (DDH) is a common disease in children, and its incidence in China is about 9 ‰.There are many different methods in the treatment of DDH. Although older children and high dislocations may be more likely to require a femoral shortening osteotomy, the ultimate decision about whether or not to shorten a given femur should depend on the ease of femoral head reduction in that specific patient. Adding a femoral shortening procedure increases operating time and blood loss, adds a second incision, and necessitates future hardware removal. In addition, an unnecessary femoral shortening osteotomy could overly decrease the soft tissue tension around the joint, putting the hip at risk for redislocation. This study was designed to explore an algorithm based on strict age and radiographic criteria that identify those without the need of femoral osteotomy. From the investigators'clinical experiences and the published papers, younger patients (<24 month of age) and low dislocations (Tonnis level I or II) were more likely to avoid a femoral shortening osteotomy.

• Study Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Not Applicable

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 2 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Unilateral DDH,age 18-24month.
2. Tonnis degree I or II.
3. Not receive any open treatment.

Exclusion Criteria:

1. Teratologic hip dislocations,
2. Patients with mental, neurological disorders (such as hypoxic-ischemic encephalopathy, epilepsy and dementia) or significant barriers to growth, cerebral palsy, multiple joint contractures disease, dysfunction of liver and kidney , blood disorders, immune deficiency disease and ECG abnormalities.
3. Any children with prior hip surgery were excluded from the series.
4. Parents refused further treatment.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Osteotomy; Femoral osteotomy are applied in the open treatment of Developmental Dislocation of the Hip （DDH）.	Procedure: Osteotomy; Femoral osteotomy are applied in the open treatment of Developmental Dislocation of the Hip （DDH）.
Experimental: Non-osteotomy; Femoral osteotomy are not applied in the open treatment of Developmental Dislocation of the Hip （DDH）.	Procedure: Non-osteotomy; Femoral osteotomy are not applied in the open treatment of Developmental Dislocation of the Hip （DDH）.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Femur Head Necrosis	Radiological evaluation was performed using standard anterior-posterior radiographs of the pelvis. The presence and grade of femur head necrosis was evaluated according to the method presented by Bucholz and Odgen.	2 years
Redislocation	Number of participants with treatment-related adverse events as assessed by CTCAE v4.0.	2 years
Acetabular index	Standardized radiographs have been traditionally used in the surveillance of hip dysplasia by measuring the acetabular index, which is the angle subtended between the Hilgenreiner line and a line drawn from the triradiate cartilage to the lateral edge of the acetabulum.	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duration of operation	The time during the operation measured by minute.	1 month
Blood loss	The blood lost during the operation measured by milliliter.	1 month
Cost	The cost of hospitalization.	1 month
Hospital stays	The days stayed in hospital.	1 month

Collaborators and Investigators

• Sponsor: He Jin Peng
• Collaborators: Wuhan Union Hospital, China; Hunan Children's Hospital; Guangzhou Women and Children's Medical Center; Shenzhen Children's Hospital; Wuhan Women and Children's Medical Center; Foshan Hospital of Traditional Chinese Medicine
• Investigators: Study Director: Fan J Shao, Doctor, Affiliated Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

Publications and helpful links

General Publications

• Sankar WN, Tang EY, Moseley CF. Predictors of the need for femoral shortening osteotomy during open treatment of developmental dislocation of the hip. J Pediatr Orthop. 2009 Dec;29(8):868-71. doi: 10.1097/BPO.0b013e3181c29cb2.
• Pospischill R, Weninger J, Ganger R, Altenhuber J, Grill F. Does open reduction of the developmental dislocated hip increase the risk of osteonecrosis? Clin Orthop Relat Res. 2012 Jan;470(1):250-60. doi: 10.1007/s11999-011-1929-4. Epub 2011 Jun 4.

Study record dates

Study Major Dates

• Study Start: December 1, 2015
• Primary Completion (Anticipated): December 1, 2018
• Study Completion (Anticipated): December 1, 2020

Study Registration Dates

• First Submitted: December 10, 2015
• First Submitted That Met QC Criteria: December 16, 2015
• First Posted (Estimate): December 17, 2015

Study Record Updates

• Last Update Posted (Estimate): December 17, 2015
• Last Update Submitted That Met QC Criteria: December 16, 2015
• Last Verified: December 1, 2015

More Information

Terms related to this study

• Keywords: osteotomy; Congenital; Hip Dislocation; Femur Head Necrosis
• Additional Relevant MeSH Terms: Pathologic Processes; Wounds and Injuries; Joint Diseases; Musculoskeletal Diseases; Bone Diseases; Hip Injuries; Osteonecrosis; Necrosis; Hip Dislocation; Joint Dislocations; Femur Head Necrosis
• Other Study ID Numbers: FSODDH; He Jin Peng (Registry Identifier: Tongji Hospital)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: The single-center data will be published in the form of case-control study.