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

P

Peking University

Status

Not yet enrolling

Conditions

Hip Fractures

Treatments

Procedure: Surgical protocol guided by artificial intelligence software

Study type

Interventional

Funder types

Other

Identifiers

NCT06195033
PekingUTH LY IF-AI

Details and patient eligibility

About

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.

Enrollment

132 estimated patients

Sex

All

Ages

60+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

132 participants in 2 patient groups

AI-guided surgical protocol group
Experimental group
Treatment:
Procedure: Surgical protocol guided by artificial intelligence software
traditional surgical protocol group
No Intervention group

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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