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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

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.


Condition or disease Intervention/treatment Phase
Femoral Neck Fractures Procedure: total hip arthroplasty or proximal femoral nails Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Diagnostic
Official Title: Collection of Bone Specimens for Testing of A Special Vessel Subtype
Study Start Date : March 2016
Estimated Primary Completion Date : February 2018
Estimated Study Completion Date : February 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: osteoporotic fractures
patients with osteoporotic fractures, including femoral neck fracture and pertrochanteric fracture. Total hip arthroplasty or proximal femoral nails was needed.
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.

Sham Comparator: nonosteoporotic fractures
patients with nonosteoporotic fractures, including femoral neck fracture and pertrochanteric fracture. Total hip arthroplasty or proximal femoral nails was needed.
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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.



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Ages Eligible for Study:   60 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02750046


Locations
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China, Jiangsu
Second Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China, 215000
Sponsors and Collaborators
Second Affiliated Hospital of Soochow University
Investigators
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Study Chair: Youjia Xu, PhD. M.D. Second Affiliated Hospital of Soochow University

Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Second Affiliated Hospital of Soochow University
ClinicalTrials.gov Identifier: NCT02750046     History of Changes
Other Study ID Numbers: SencondSoochowU
First Posted: April 25, 2016    Key Record Dates
Last Update Posted: April 25, 2016
Last Verified: April 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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