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

Not Applicable

Not yet recruiting

• Conditions: Hip Fractures
• Interventions: Procedure: Surgical protocol guided by artificial intelligence software

• Registration Number: NCT06195033
• Lead Sponsor: Peking University Third Hospital

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-12
• Study First Submitted: 2023-12-22
• Study First Submitted QC: 2023-12-22
• Last Update Submitted: 2023-12-22
• Study Start: 2024-01
• Study First Posted: 2024-01-08
• Last Update Posted: 2024-01-08
• Primary Completion: 2024-10
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 132

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
AI-guided surgical protocol group	Surgical protocol guided by artificial intelligence software	-

Primary Outcome Measures

Name	Time	Method
Fracture healing situation 36 weeks after surgery	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.