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

Study Overview
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Brief Summary
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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
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OBJECTIVES: Establish type H vessel in bone specimen in patients with hip fracture. Explore the correlation of BMD and type H vessel. OUTLINE: Collect human bone specimens from patients with Osteoporotic and Nonosteoporotic Fracture. Provide a repository for storage of tissue and make these specimens available for approved projects by laboratory-based investigators. Observe the type H vessel in bone slice by immunofluorescence staining. Collect clinical data on these patients including bone mineral density. Investigate the relationship between BMD and type H vessel.

Official Title
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Collection of Bone Specimens for Testing of A Special Vessel Subtype

Conditions
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Femoral Neck Fractures

Intervention / Treatment
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* Procedure: total hip arthroplasty or proximal femoral nails


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Ages Eligible for Study: 65-75 Years Genders Eligible for Study: Woman Accepts Healthy Volunteers: NO Study Population: Female patients with hip fracture. - Exclusion Criteria: Malignancy or benign ovarian cysts Known chronic or systemic diseases Hormone therapy in the previous 3 months Bone metabolism and drug therapy

Ages Eligible for Study
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Minimum Age: 60 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: osteoporotic fractures<br>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<br>* Bone samples from Hip fracture were collected when total hip arthroplasty or proximal femoral nails was performed.<br>|
| Sham Comparator: nonosteoporotic fractures<br>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<br>* Bone samples from Hip fracture were collected when total hip arthroplasty or proximal femoral nails was performed.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The area of a special vessel subtype in human bone samples | 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. | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The value of bone mineral density | Bone mineral density was measured by double energy X-ray absorptiometer (DXA) in a week before surgery. | 1 week | 
| Correlation of of bone mineral density and area of a special vessel subtype in human bone | Calculate correlation coefficient of BMD and type H vessel in human bone samples in 2 months. | 2 months |