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

Femur Head Necrosis Clinical Trial

— FSODDH  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02633904
• Other study ID #: FSODDH
• Secondary ID: He Jin Peng
• Status: Not yet recruiting
• Phase: N/A
• First received: December 10, 2015
• Last updated: December 16, 2015
• Start date: December 2015
• Est. completion date: December 2020

Study information

• Verified date: December 2015
• Source: Tongji Hospital
• Contact: Peng J He, Doctor
• Phone: +86-15071032254
• Email: 619921411[@]qq.com
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: December 2020
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Months to 24 Months

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dislocations
• Femur Head Necrosis
• Hip Dislocation
• Necrosis

Intervention

Procedure:
• Osteotomy
Femoral osteotomy are applied in the open treatment of Developmental Dislocation of the Hip (DDH).
• Non-osteotomy
Femoral osteotomy are not applied in the open treatment of Developmental Dislocation of the Hip (DDH).

Locations

Country	Name	City	State
n/a

Sponsors (7)

Lead Sponsor	Collaborator
He Jin Peng	Foshan Hospital of Traditional Chinese Medicine, Guangzhou Women and Children's Medical Center, Hunan Children's Hospital, Shenzhen Children's Hospital, Wuhan Union Hospital, China, Wuhan Women and Children's Medical Center

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Primary	Redislocation	Number of participants with treatment-related adverse events as assessed by CTCAE v4.0.	2 years	Yes
Primary	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	Yes
Secondary	Duration of operation	The time during the operation measured by minute.	1 month	Yes
Secondary	Blood loss	The blood lost during the operation measured by milliliter.	1 month	Yes
Secondary	Cost	The cost of hospitalization.	1 month	Yes
Secondary	Hospital stays	The days stayed in hospital.	1 month	Yes