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

NCT ID: NCT02633904

Last Updated: 2015-12-17

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-12-31
• Study Completion Date: 2020-12-31

Brief 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.

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.

Conditions

Hip Dislocation; Femur Head Necrosis

Keywords

Hip Dislocation; Congenital; osteotomy; Femur Head Necrosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Osteotomy

Femoral osteotomy are applied in the open treatment of Developmental Dislocation of the Hip （DDH）.

Group Type: ACTIVE_COMPARATOR

Osteotomy

Intervention Type: PROCEDURE

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）.

Group Type: EXPERIMENTAL

Non-osteotomy

Intervention Type: PROCEDURE

Femoral osteotomy are not applied in the open treatment of Developmental Dislocation of the Hip （DDH）.

Interventions

Osteotomy

Femoral osteotomy are applied in the open treatment of Developmental Dislocation of the Hip （DDH）.

Intervention Type: PROCEDURE

Non-osteotomy

Femoral osteotomy are not applied in the open treatment of Developmental Dislocation of the Hip （DDH）.

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Months
• Maximum Eligible Age: 24 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hunan Children's Hospital

OTHER_GOV

Sponsor Role: collaborator

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

OTHER

Sponsor Role: collaborator

Guangzhou Women and Children's Medical Center

OTHER

Sponsor Role: collaborator

Wuhan Women and Children's Medical Center

OTHER

Sponsor Role: collaborator

Shenzhen Children's Hospital

OTHER_GOV

Sponsor Role: collaborator

Foshan Hospital of Traditional Chinese Medicine

OTHER

Sponsor Role: collaborator

He Jin Peng

OTHER

Sponsor Role: lead

Responsible Party

He Jin Peng

Resident doctor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Fan J Shao, Doctor

Role: STUDY_DIRECTOR

Affiliated Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

Central Contacts

Peng J He, Doctor

Role: CONTACT

Phone: +86-15071032254

Email: 619921411@qq.com

References

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.

Reference Type: RESULT

PMID: 19934701 (View on PubMed)

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.

Reference Type: RESULT

PMID: 21643924 (View on PubMed)

Other Identifiers

He Jin Peng

Identifier Type: REGISTRY

Identifier Source: secondary_id

FSODDH

Identifier Type: -

Identifier Source: org_study_id