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

NCT ID: NCT06195033

Last Updated: 2024-01-08

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 132 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-31
• Study Completion Date: 2024-12-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

AI-guided surgical protocol group

Group Type: EXPERIMENTAL

Surgical protocol guided by artificial intelligence software

Intervention Type: 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.

traditional surgical protocol group

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Surgical protocol guided by artificial intelligence software

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.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

1. Over 60 years old, male or female.

2. Osteoporosis intertrochanteric fracture, which met the diagnostic criteria of X-ray intertrochanteric fracture, and osteoporosis T-value <2.5.

3. Patients with 1mm resolution CT imaging data.

4. Willing to participate in the project, sign the informed consent, and be able to complete the follow-up work.

Exclusion Criteria

1. Patients with pathological fractures, old fractures, stress fractures, and periprosthesis fractures;

2. Patients lacking 1mm resolution CT imaging data;

3. Severe malnutrition, heavy smoking, alcoholism and other systemic conditions affect fracture healing;

4. Patients with severe medical diseases that cannot be operated on;

5. Patients participating in other clinical studies.

• Minimum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Peking University Third Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

PekingUTH LY IF-AI

Identifier Type: -

Identifier Source: org_study_id