Randomized Controlled Clinical Trial of Internal Fixation of Intertrochanteric Fractures of Femur Guided by Conventional Versus IF-AI Artificial Intelligence Program

NCT06195033 | Unknown

• 1 other identifier: PekingUTH LY IF-AI
• Study Type: interventional
• Target: 132
• Locations: 0 countries
• Sites: N/A

Brief Summary

Our team has developed an AI software to guide the surgical protocol for femoral intertrochanteric fractures. This is a prospective randomized controlled clinical study that will include patients with femoral intertrochanteric fractures combining medial posterior and lateral wall fractures, and will randomly divide the patients into a traditional surgical protocol group and an AI-guided surgical protocol group. The efficacy and safety indexes such as operation time, blood loss, operation cost, infection rate, hospitalization time, postoperative pain score, fracture healing time, internal fixation failure rate and mortality rate were compared between the two groups to verify the efficacy and safety of AI-guided surgical treatment plan.

Conditions

Hip Fractures

Outcome Measures

Primary Outcomes (1)

• Fracture healing situation 36 weeks after surgery

  The results of surgical treatment of the patient were shown by imaging data at 36 weeks after surgery, and the treatment was considered successful without failure of internal fixation.

  36 weeks after surgery

Study Arms (2)

AI-guided surgical protocol group

EXPERIMENTAL

Procedure: Surgical protocol guided by artificial intelligence software

traditional surgical protocol group

NO INTERVENTION

Interventions

Surgical protocol guided by artificial intelligence software PROCEDURE

At present, the indications for internal fixation of intertrochanteric fractures are not clear. We developed an artificial intelligence software to assist surgeons in determining whether to immobilize lateral and medial posterior wall fractures.

AI-guided surgical protocol group

Eligibility Criteria

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

You may qualify if:

• Over 60 years old, male or female.
• Osteoporosis intertrochanteric fracture, which met the diagnostic criteria of X-ray intertrochanteric fracture, and osteoporosis T-value \<2.5.
• Patients with 1mm resolution CT imaging data.
• Willing to participate in the project, sign the informed consent, and be able to complete the follow-up work.

You may not qualify if:

• Patients with pathological fractures, old fractures, stress fractures, and periprosthesis fractures;
• Patients lacking 1mm resolution CT imaging data;
• Severe malnutrition, heavy smoking, alcoholism and other systemic conditions affect fracture healing;
• Patients with severe medical diseases that cannot be operated on;
• Patients participating in other clinical studies.

Sponsors & Collaborators

• Peking University Third Hospital: lead

MeSH Terms

Conditions

Hip Fractures

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 22, 2023
• First Posted: January 8, 2024
• Study Start: January 1, 2024
• Primary Completion: October 1, 2024
• Study Completion: December 1, 2024
• Last Updated: January 8, 2024

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share