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

Sponsor

Second Affiliated Hospital of Soochow University (Other)

Overall Status

Unknown status

CT.gov ID

NCT02750046

Collaborator

(none)

Enrollment

Location

Arms

23.1

Duration (Months)

1.3

Patients Per Site Per Month

Study Details

Study Description

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	N/A

Detailed Description

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.

Study Design

Study Type:

Interventional

Anticipated 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 :

Mar 1, 2016

Anticipated Primary Completion Date :

Feb 1, 2018

Anticipated Study Completion Date :

Feb 1, 2018

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

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

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

60 Years to 75 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Second Affiliated Hospital of Soochow University	Suzhou	Jiangsu	China	215000

Sponsors and Collaborators

Second Affiliated Hospital of Soochow University

Investigators

Study Chair: Youjia Xu, PhD. M.D., Second Affiliated Hospital of Soochow University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Second Affiliated Hospital of Soochow University

ClinicalTrials.gov Identifier:

NCT02750046

Other Study ID Numbers:

SencondSoochowU

First Posted:

Apr 25, 2016

Last Update Posted:

Apr 25, 2016

Last Verified:

Apr 1, 2016

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Additional relevant MeSH terms:

Femoral Neck Fractures

Study Results

No Results Posted as of Apr 25, 2016