Overview

This trial is active, not recruiting.

Condition femoral neck fractures
Treatment total hip arthroplasty or proximal femoral nails
Sponsor Second Affiliated Hospital of Soochow University
Start date March 2016
End date February 2018
Trial size 30 participants
Trial identifier NCT02750046, SencondSoochowU

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking single blind (subject)
Primary purpose diagnostic
Arm
(Experimental)
patients with osteoporotic fractures, including femoral neck fracture and pertrochanteric fracture. Total hip arthroplasty or proximal femoral nails was needed.
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)
patients with nonosteoporotic fractures, including femoral neck fracture and pertrochanteric fracture. Total hip arthroplasty or proximal femoral nails was needed.
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 Outcomes

Measure
The area of a special vessel subtype in human bone samples
time frame: 3 months

Secondary Outcomes

Measure
The value of bone mineral density
time frame: 1 week
Correlation of of bone mineral density and area of a special vessel subtype in human bone
time frame: 2 months

Eligibility Criteria

Female participants from 60 years up to 75 years old.

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

Additional Information

Official title Collection of Bone Specimens for Testing of A Special Vessel Subtype
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.
Trial information was received from ClinicalTrials.gov and was last updated in April 2016.
Information provided to ClinicalTrials.gov by Second Affiliated Hospital of Soochow University.