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

NCT05171140 | Unknown DMC

• 1 other identifier: 2020YJZX0112
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

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.

Conditions

Femoral Neck Fracture

Keywords

Femoral Neck Fracture; Robot assisted; Blood supply of femoral head

Outcome Measures

Primary Outcomes (4)

• comparison of hip joint function at 6 months

  Harris score

  6 months after surgery

• comparison of hip joint function at 12 months

  Harris score

  12 months after surgery

• 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

• 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 Outcomes (2)

• Intraoperative indicators-surgical blood loss

  Intraoperative

• Intraoperative indicators-operation time

  Intraoperative

Study Arms (2)

Hollow nails are arranged in a triangle

EXPERIMENTAL

Hollow nails are arranged in a triangle

Procedure: Triangular Nail Placement of Femoral Neck

Hollow nail inverted triangle arrangement

EXPERIMENTAL

Hollow nail inverted triangle arrangement

Procedure: Triangular Nail Placement of Femoral Neck

Interventions

Triangular Nail Placement of Femoral Neck PROCEDURE

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

Hollow nail inverted triangle arrangement; Hollow nails are arranged in a triangle

Eligibility Criteria

• Age: 60 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• RenJi Hospital: lead

Study Sites (1)

Renji Hospital

Shanghai, Shanghai Municipality, 200127, China

RECRUITING

MeSH Terms

Conditions

Femoral Neck Fractures

Condition Hierarchy (Ancestors)

Hip Fractures; Femoral Fractures; Fractures, Bone; Wounds and Injuries; Hip Injuries; Leg Injuries

Study Officials

• Ping Huang, Master

  Shanghai Jiaotong University School of Medical Renji Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ping Huang, Master

CONTACT

+86 13916121692; 8813@renji.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 22, 2021
• First Posted: December 28, 2021
• Study Start: September 1, 2020
• Primary Completion: January 31, 2023
• Study Completion: August 31, 2023
• Last Updated: December 28, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)