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

NCT02633904 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2015-12-17

No results posted yet for this study

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

Interventions

PROCEDURE

Osteotomy

Femoral osteotomy are 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).

Sponsors & Collaborators

  • Hunan Children's Hospital

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

    collaborator OTHER
  • Guangzhou Women and Children's Medical Center

    collaborator OTHER
  • Wuhan Women and Children's Medical Center

    collaborator OTHER
  • Shenzhen Children's Hospital

    collaborator OTHER_GOV
  • Foshan Hospital of Traditional Chinese Medicine

    collaborator OTHER
  • He Jin Peng

    lead OTHER

Principal Investigators

  • Fan J Shao, Doctor · Affiliated Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Months
Max Age
24 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-12-31
Primary Completion
2018-12-31
Completion
2020-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02633904 on ClinicalTrials.gov