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

NCT02633904 | Unknown DMC

• 2 other identifiers: FSODDHHe Jin Peng
• Study Type: interventional
• Target: 200
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Hip Dislocation; Femur Head Necrosis

Keywords

Hip Dislocation; Congenital; osteotomy; Femur Head Necrosis

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (4)

• Duration of operation

  1 month

• Blood loss

  1 month

• Cost

  1 month

• Hospital stays

  1 month

Study Arms (2)

Osteotomy

ACTIVE COMPARATOR

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

Procedure: Osteotomy

Non-osteotomy

EXPERIMENTAL

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

Procedure: Non-osteotomy

Interventions

Osteotomy PROCEDURE

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

Osteotomy

Non-osteotomy PROCEDURE

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

Non-osteotomy

Eligibility Criteria

• Age: 18 Months - 24 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• Teratologic hip dislocations,
• 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.
• Any children with prior hip surgery were excluded from the series.
• Parents refused further treatment.

Sponsors & Collaborators

• He Jin Peng: lead
• Hunan Children's Hospital: collaborator
• Union Hospital, Tongji Medical College, Huazhong University of Science and Technology: collaborator
• Guangzhou Women and Children's Medical Center: collaborator
• Wuhan Women and Children's Medical Center: collaborator
• Shenzhen Children's Hospital: collaborator
• Foshan Hospital of Traditional Chinese Medicine: collaborator

Related Publications (2)

• 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.

  PMID: 19934701 RESULT

• 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.

  PMID: 21643924 RESULT

MeSH Terms

Conditions

Hip Dislocation; Femur Head Necrosis

Interventions

Osteotomy

Condition Hierarchy (Ancestors)

Joint Dislocations; Joint Diseases; Musculoskeletal Diseases; Wounds and Injuries; Hip Injuries; Osteonecrosis; Bone Diseases; Necrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Orthopedic Procedures; Surgical Procedures, Operative

Study Officials

• Fan J Shao, Doctor

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

  STUDY DIRECTOR

Central Study Contacts

Peng J He, Doctor

CONTACT

+86-15071032254; 619921411@qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Resident doctor

Study Record Dates

• First Submitted: December 10, 2015
• First Posted: December 17, 2015
• Study Start: December 1, 2015
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2020
• Last Updated: December 17, 2015

Record last verified: 2015-12

Data Sharing

• IPD Sharing: Will share