Titanium Elastic Nailing Versus Hip Spica Cast in Treatment of Femoral Fractures in Children

This study has been completed.
Sponsor:
Information provided by:
Isfahan University of Medical Sciences
ClinicalTrials.gov Identifier:
NCT01190696
First received: August 27, 2010
Last updated: NA
Last verified: February 2009
History: No changes posted
  Purpose

The purpose of this study is to determine which method is better for treatment of femoral fracture in children in outcomes.


Condition Intervention Phase
Femoral Shaft Fracture
Procedure: titanium elastic nailing
Device: Hip spica casting
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Study of Surgical Method Versus Casting for Treatment of Femoral Fracture in Children

Resource links provided by NLM:


Further study details as provided by Isfahan University of Medical Sciences:

Primary Outcome Measures:
  • Length of hospital stay [ Time Frame: at 1 months post-operatively ] [ Designated as safety issue: Yes ]
    identification of Length of hospital stay (days)for patients who treated with titanium elastic nailing or casting


Secondary Outcome Measures:
  • the time to walking with aids [ Time Frame: at 1 months post-operatively ] [ Designated as safety issue: Yes ]
    identification of the time to walking with aids in patients who treated with titanium elastic nailing or casting

  • parent's satisfaction [ Time Frame: at 1 months post-operatively ] [ Designated as safety issue: Yes ]
    identification of parent's satisfaction with questionnair in patients who treated with titanium elastic nailing or casting

  • the time absent from school [ Time Frame: at 1 months post-operatively ] [ Designated as safety issue: Yes ]
    identification of the time absent from school in patients who treated with titanium elasting nailing or casting


Enrollment: 46
Study Start Date: February 2009
Study Completion Date: January 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
hip spica casting
Patients in the spica cast group treated with skeletal traction and spica cast applied for them
Device: Hip spica casting
we applied cast for three weeks in patients with femoral shaft fracture
Other Name: TEN
titanium elasting nailing
For patients in the Titanium Elasting Nailing group, the nail applied retrogradely in femoral shaft fracture
Procedure: titanium elastic nailing
we inserted titanium nail in femoral fractures retrogradely
Other Name: TEN

Detailed Description:

There is no consensus on treatment of closed femoral shaft fractures in children 6-12years old. We aimed to compare hip spica cast with titanium elastic nailing (TEN) in the treatment of femoral shaft fractures in children.

  Eligibility

Ages Eligible for Study:   6 Years to 12 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • patients 6-12 years old with femoral shaft fracture without exclusion criteria

Exclusion Criteria:

  • Segmental, Winquist type III and IV comminuted fractures, previously diagnosed neuromuscular disease (e.g., cerebral palsy), metabolic bone disorders (e.g. osteomalacia), or pathological fractures.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01190696

Locations
Iran, Islamic Republic of
Al-zahra university hospital
Isfahan, Iran, Islamic Republic of
Sponsors and Collaborators
Isfahan University of Medical Sciences
Investigators
Study Chair: hamidreza shemshaki, MD MD,research comittee
  More Information

Additional Information:
No publications provided

Responsible Party: Dr. Alireza Yousefy/Associate Professor of Medical Education, Isfahan University of Medical Sciences
ClinicalTrials.gov Identifier: NCT01190696     History of Changes
Other Study ID Numbers: ASD-1213-5
Study First Received: August 27, 2010
Last Updated: August 27, 2010
Health Authority: Iran: Ministry of Health

Keywords provided by Isfahan University of Medical Sciences:
Spica Cast
TEN
Femoral Shaft Fracture
Children

Additional relevant MeSH terms:
Fractures, Bone
Femoral Fractures
Wounds and Injuries
Leg Injuries

ClinicalTrials.gov processed this record on October 02, 2014