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

Femoral Neck Fracture Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05171140
• Other study ID #: 2020YJZX0112
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2020
• Est. completion date: August 31, 2023

Study information

• Verified date: November 2021
• Source: RenJi Hospital
• Contact: Ping Huang, Master
• Phone: +86 13916121692
• Email: 8813[@]renji.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 68
• Est. completion date: August 31, 2023
• Est. primary completion date: January 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Femoral Neck Fracture
• Femoral Neck Fractures
• Fractures, Bone

Intervention

Procedure:
• Triangular Nail Placement of Femoral Neck
Triangular Nail Placement of Femoral Neck in arm A Femoral Neck Inverted Triangle Nail Surgery in arm B

Locations

Country	Name	City	State
China	Renji Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
RenJi Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	comparison of hip joint function at 6 months	Harris score	6 months after surgery
Primary	comparison of hip joint function at 12 months	Harris score	12 months after surgery
Primary	Imaging evaluation of the vascular condition of the femoral head epiphysis before surgery	Imaging evaluation of the vascular condition of the femoral head epiphysis	One day before surgery
Primary	Imaging evaluation of the vascular condition of the femoral head epiphysis after surgery	Imaging evaluation of the vascular condition of the femoral head epiphysis	2 months after surgery
Secondary	Intraoperative indicators-surgical blood loss	surgical blood loss(ml)	Intraoperative
Secondary	Intraoperative indicators-operation time	operation time(minute)	Intraoperative