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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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06195033
Enrollment
132
Registered
2024-01-08
Start date
2024-01-31
Completion date
2024-12-31
Last updated
2024-01-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hip Fractures

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.

Interventions

PROCEDURESurgical 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.

Sponsors

Peking University Third Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Fracture healing situation 36 weeks after surgery36 weeks after surgeryThe 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.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026