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Influence of the Spatial Distribution of Hollow Screws on the Blood Supply and Prognosis of Femoral Neck Fractures

Primary Purpose

Femoral Neck Fracture

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Triangular Nail Placement of Femoral Neck
Sponsored by
RenJi Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Femoral Neck Fracture focused on measuring Femoral Neck Fracture, Robot assisted, Blood supply of femoral head

Eligibility Criteria

60 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • A new initial intracapsular fracture of the femoral neck;
  • Garden classification I or II;
  • Accept closed reduction robot-assisted hollow nail surgery;
  • ASA score 1-2, can tolerate anesthesia;
  • Age 60-80 years old (inclusive);
  • Able to fully understand and voluntarily sign informed consent.

Exclusion Criteria:

  • Old or pathological fractures;
  • Patients with acetabular fracture;
  • Those who have general conditions or accompanying diseases that make it difficult for people to tolerate surgery, such as: coagulation dysfunction, or heart, liver, and kidney dysfunction;
  • Severe infections systemically or locally;
  • Those who refuse to sign informed consent;
  • In any case, if the researcher believes that the patient is not suitable for this treatment or there are other factors that affect the efficacy of the observation of this study.

Sites / Locations

  • Renji HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Hollow nails are arranged in a triangle

Hollow nail inverted triangle arrangement

Arm Description

Hollow nails are arranged in a triangle

Hollow nail inverted triangle arrangement

Outcomes

Primary Outcome Measures

comparison of hip joint function at 6 months
Harris score
comparison of hip joint function at 12 months
Harris score
Imaging evaluation of the vascular condition of the femoral head epiphysis before surgery
Imaging evaluation of the vascular condition of the femoral head epiphysis
Imaging evaluation of the vascular condition of the femoral head epiphysis after surgery
Imaging evaluation of the vascular condition of the femoral head epiphysis

Secondary Outcome Measures

Intraoperative indicators-surgical blood loss
surgical blood loss(ml)
Intraoperative indicators-operation time
operation time(minute)

Full Information

First Posted
November 22, 2021
Last Updated
December 14, 2021
Sponsor
RenJi Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05171140
Brief Title
Influence of the Spatial Distribution of Hollow Screws on the Blood Supply and Prognosis of Femoral Neck Fractures
Official Title
Influence of Different Spatial Distribution of Hollow Screws on Blood Supply and Prognosis of Femoral Neck Fractures in the Elderly
Study Type
Interventional

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Recruiting
Study Start Date
September 1, 2020 (Actual)
Primary Completion Date
January 31, 2023 (Anticipated)
Study Completion Date
August 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
RenJi Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Femoral neck fracture is a common type of fracture in the elderly. For those without significant displacement (Garden I, II), more hip-preserving treatment strategies are adopted. The classic parallel hollow screw internal fixation for hip-preserving treatment is based on the sliding compression theory, and a clinical debate has gradually emerged, that is, the positive triangle And the two different spatial distribution methods of hollow nails and inverted triangle, which one is better. In addition, the distribution of hollow nails in actual operations is difficult to achieve a standard triangular distribution, and the damage to the epiphyseal vessels in the femoral head caused by repeated drilling of the guide needle cannot always be ignored. The relationship between the distribution and injury of blood vessels in the femoral head and the spatial distribution of hollow screws on the prognosis of head necrosis of non-displaced femoral neck fractures in the elderly is worth studying. This topic is based on the three advantages of TianJi orthopedic robots used in the elderly femoral neck fracture hollow nail hip-saving surgery: 1.standardized triangular nail placement with strong repeatability; 2. precise nail placement to reduce the risk of screw penetration; 3. limited guide pins The number of drill holes is to rule out repeated drill holes that damage the blood vessels in the femoral head. The preoperative and postoperative vascular injury in the femoral head (enhanced MRI of the femoral head) was compared to assess the prognosis of patients, and to clarify the influence of the spatial distribution of hollow screws on the blood supply and prognosis of the femoral neck fracture in the elderly.
Detailed Description
the investigators choose 60-80-year-old Garden I or II patients with initial fractures. Hollow nails are the first choice for treatment of these patients. However, the spatial arrangement of hollow nails, local blood supply, and biomechanical properties have a greater impact on the prognosis of fractures. , There are still some controversies, which are also the current research hotspots. Our research conclusions may increase the success rate of hip preservation and will guide the treatment of these patients. This study is based on the precise placement of nails by the Dimensity orthopedic robot, and compares the vascular injury of the femoral head before and after the nail placement (femoral head enhanced MRI) to assess the prognosis of the patient. The influence of blood supply and prognosis of femoral neck fracture in the elderly.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Femoral Neck Fracture
Keywords
Femoral Neck Fracture, Robot assisted, Blood supply of femoral head

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
68 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Hollow nails are arranged in a triangle
Arm Type
Experimental
Arm Description
Hollow nails are arranged in a triangle
Arm Title
Hollow nail inverted triangle arrangement
Arm Type
Experimental
Arm Description
Hollow nail inverted triangle arrangement
Intervention Type
Procedure
Intervention Name(s)
Triangular Nail Placement of Femoral Neck
Intervention Description
Triangular Nail Placement of Femoral Neck in arm A Femoral Neck Inverted Triangle Nail Surgery in arm B
Primary Outcome Measure Information:
Title
comparison of hip joint function at 6 months
Description
Harris score
Time Frame
6 months after surgery
Title
comparison of hip joint function at 12 months
Description
Harris score
Time Frame
12 months after surgery
Title
Imaging evaluation of the vascular condition of the femoral head epiphysis before surgery
Description
Imaging evaluation of the vascular condition of the femoral head epiphysis
Time Frame
One day before surgery
Title
Imaging evaluation of the vascular condition of the femoral head epiphysis after surgery
Description
Imaging evaluation of the vascular condition of the femoral head epiphysis
Time Frame
2 months after surgery
Secondary Outcome Measure Information:
Title
Intraoperative indicators-surgical blood loss
Description
surgical blood loss(ml)
Time Frame
Intraoperative
Title
Intraoperative indicators-operation time
Description
operation time(minute)
Time Frame
Intraoperative

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: A new initial intracapsular fracture of the femoral neck; Garden classification I or II; Accept closed reduction robot-assisted hollow nail surgery; ASA score 1-2, can tolerate anesthesia; Age 60-80 years old (inclusive); Able to fully understand and voluntarily sign informed consent. Exclusion Criteria: Old or pathological fractures; Patients with acetabular fracture; Those who have general conditions or accompanying diseases that make it difficult for people to tolerate surgery, such as: coagulation dysfunction, or heart, liver, and kidney dysfunction; Severe infections systemically or locally; Those who refuse to sign informed consent; In any case, if the researcher believes that the patient is not suitable for this treatment or there are other factors that affect the efficacy of the observation of this study.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ping Huang, Master
Phone
+86 13916121692
Email
8813@renji.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ping Huang, Master
Organizational Affiliation
Shanghai Jiaotong University School of Medical Renji Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Renji Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200127
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ping Huang
Phone
+8613916121692
Email
8813@renji.com

12. IPD Sharing Statement

Plan to Share IPD
No

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Influence of the Spatial Distribution of Hollow Screws on the Blood Supply and Prognosis of Femoral Neck Fractures

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