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

Not Applicable

• Conditions: Femoral Neck Fractures
• Interventions: Procedure: total hip arthroplasty or proximal femoral nails

• Registration Number: NCT02750046
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2016-03
• Study First Submitted: 2016-03-24
• Status Verified: 2016-04
• Study First Submitted QC: 2016-04-20
• Last Update Submitted: 2016-04-20
• Study First Posted: 2016-04-25
• Last Update Posted: 2016-04-25
• Primary Completion: 2018-02
• Study Completion: 2018-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
nonosteoporotic fractures	total hip arthroplasty or proximal femoral nails	patients with nonosteoporotic fractures, including femoral neck fracture and pertrochanteric fracture. Total hip arthroplasty or proximal femoral nails was needed.
osteoporotic fractures	total hip arthroplasty or proximal femoral nails	patients with osteoporotic fractures, including femoral neck fracture and pertrochanteric fracture. Total hip arthroplasty or proximal femoral nails was needed.

Primary Outcome Measures

Name	Time	Method
The area of a special vessel subtype in human bone samples	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

Name	Time	Method
The value of bone mineral density	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	2 months	Calculate correlation coefficient of BMD and type H vessel in human bone samples in 2 months.

Trial Locations

Locations (1)

Second Affiliated Hospital of Soochow University; 🇨🇳 Suzhou, Jiangsu, China