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Study of A Special Vessel Subtype in Bone Samples From Patients With Osteoporotic and Nonosteoporotic Fracture

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ClinicalTrials.gov Identifier: NCT02750046
Recruitment Status : Unknown
Verified April 2016 by Second Affiliated Hospital of Soochow University.
Recruitment status was:  Active, not recruiting
First Posted : April 25, 2016
Last Update Posted : April 25, 2016
Sponsor:
Information provided by (Responsible Party):
Second Affiliated Hospital of Soochow University

Tracking Information
First Submitted Date  ICMJE March 24, 2016
First Posted Date  ICMJE April 25, 2016
Last Update Posted Date April 25, 2016
Study Start Date  ICMJE March 2016
Estimated Primary Completion Date February 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 20, 2016)
The area of a special vessel subtype in human bone samples [ Time Frame: 3 months ]
Bone samples were fixed in 4% PFA, decalcified, dehydrated, embedded and immunofluorescent staining for 3 months. Calculate the proportion of the special vessel of total vessel.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: April 20, 2016)
  • The value of bone mineral density [ Time Frame: 1 week ]
    Bone mineral density was measured by double energy X-ray absorptiometer (DXA) in a week before surgery.
  • Correlation of of bone mineral density and area of a special vessel subtype in human bone [ Time Frame: 2 months ]
    Calculate correlation coefficient of BMD and type H vessel in human bone samples in 2 months.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of A Special Vessel Subtype in Bone Samples From Patients With Osteoporotic and Nonosteoporotic Fracture
Official Title  ICMJE Collection of Bone Specimens for Testing of A Special Vessel Subtype
Brief Summary

RATIONALE: Collecting and storing bone samples from patients with osteoporotic and nonosteoporotic fracture to study a special vessel subtype in the laboratory may help surgeon learn more about the relationship between bone mineral density (BMD) and a special vessel subtype (type H vessel).

PURPOSE: This research study is looking at changes of a special vessel subtype in bone samples from patients with osteoporotic and nonosteoporotic fracture.

Detailed Description

OBJECTIVES:

  1. Establish type H vessel in bone specimen in patients with hip fracture.
  2. Explore the correlation of BMD and type H vessel.

OUTLINE:

  1. Collect human bone specimens from patients with Osteoporotic and Nonosteoporotic Fracture.
  2. Provide a repository for storage of tissue and make these specimens available for approved projects by laboratory-based investigators.
  3. Observe the type H vessel in bone slice by immunofluorescence staining.
  4. Collect clinical data on these patients including bone mineral density.
  5. Investigate the relationship between BMD and type H vessel.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Diagnostic
Condition  ICMJE Femoral Neck Fractures
Intervention  ICMJE Procedure: total hip arthroplasty or proximal femoral nails
Bone samples from Hip fracture were collected when total hip arthroplasty or proximal femoral nails was performed.
Study Arms  ICMJE
  • Experimental: osteoporotic fractures
    patients with osteoporotic fractures, including femoral neck fracture and pertrochanteric fracture. Total hip arthroplasty or proximal femoral nails was needed.
    Intervention: Procedure: total hip arthroplasty or proximal femoral nails
  • Sham Comparator: nonosteoporotic fractures
    patients with nonosteoporotic fractures, including femoral neck fracture and pertrochanteric fracture. Total hip arthroplasty or proximal femoral nails was needed.
    Intervention: Procedure: total hip arthroplasty or proximal femoral nails
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: April 20, 2016)
30
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE February 2018
Estimated Primary Completion Date February 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Ages Eligible for Study: 65-75 Years
  2. Genders Eligible for Study: Woman
  3. Accepts Healthy Volunteers: NO
  4. Study Population: Female patients with hip fracture. -

Exclusion Criteria:

  1. Malignancy or benign ovarian cysts
  2. Known chronic or systemic diseases
  3. Hormone therapy in the previous 3 months
  4. Bone metabolism and drug therapy
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 60 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02750046
Other Study ID Numbers  ICMJE SencondSoochowU
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Second Affiliated Hospital of Soochow University
Study Sponsor  ICMJE Second Affiliated Hospital of Soochow University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Youjia Xu, PhD. M.D. Second Affiliated Hospital of Soochow University
PRS Account Second Affiliated Hospital of Soochow University
Verification Date April 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP