Observational Study on AI Accuracy in Diagnosing and Treating Failed or Painful Hip Arthroplasty
NCT07012577 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 20
Last updated 2025-06-18
Summary
Primary Goal:
This study aims to evaluate the diagnostic and therapeutic accuracy of GPT-4 (an advanced AI language model) compared to three orthopedic surgeons with varying experience levels in cases of failed or painful total hip arthroplasty.
Key Research Questions:
Diagnostic Accuracy:
Does GPT-4 provide correct, partially correct, or incorrect diagnoses compared to human orthopaedic surgeons?
Diagnostic Completeness:
Are GPT-4's diagnostic suggestions complete, partially complete, or incomplete compared to those of orthopedic surgeons?
Treatment Accuracy:
Does GPT-4 recommend correct, partially correct, or incorrect treatments for failed hip arthroplasty?
Treatment Completeness:
Are GPT-4's treatment recommendations fully comprehensive, partially complete, or incomplete compared to those of orthopaedic surgeon?
Study Design:
Participants:
20 anonymized patient cases (ages 18-80) with failed or painful hip arthroplasties, treated at IRCCS Istituto Ortopedico Rizzoli (Bologna, Italy) between 2004-2024.
Cases were selected based on clear diagnostic and treatment records (no ambiguous or incomplete data).
Comparison Groups:
GPT-4 (via ChatGPT interface)
Three orthopedic doctors (with different experience levels: resident, specialist, senior surgeon)
Method:
Each case (clinical summary + X-ray image) is presented to GPT-4 and the three doctors.
They must provide a diagnosis and treatment recommendations.
Two independent evaluators (principal investigator + department head) blindly assess responses for correctness and completeness using a 3-point scale (0=wrong/incomplete, 2=correct/complete).
Statistical analysis compares GPT-4 vs. human performance.
Expected Outcomes:
Determine if AI can match or outperform doctors in diagnosing and treating hip arthroplasty failures.
Assess whether GPT-4 could serve as a supplementary tool in orthopedic decision-making.
Ethical \& Privacy Considerations:
No real-time patient data is used-only anonymized past cases.
No personal/sensitive data is shared with OpenAI (GPT-4 is used via a standard web interface).
Study complies with GDPR, HIPAA, and ethical AI guidelines.
Timeline:
Study duration: \~8 months (from ethics approval to final analysis).
Results will be published regardless of outcome.
Why This Study Matters:
First study evaluating GPT-4's role in complex orthopedic diagnostics.
Could influence future AI-assisted clinical decision-making in joint replacement surgeries.
Conditions
- Total Hip Arthroplasty (THA)
Interventions
- OTHER
-
GPT-4 Assessment
Diagnostic/Prognostic evaluation of any single case provided by AI (GPT-4). GPT-4 provides diagnosis/treatment recommendations via standardized prompts
- OTHER
-
Arthroplasty Fellow Assessment
Diagnostic/Prognostic evaluation of any single case provided by an human expert
- OTHER
-
Specializing Resident (4th year) Assessment
Diagnostic/Prognostic evaluation of any single case provided by an human expert
- OTHER
-
Junior Resident (3rd year) Assessment
Diagnostic/Prognostic evaluation of any single case provided by an human expert
Sponsors & Collaborators
-
Istituto Ortopedico Rizzoli
lead OTHER
Principal Investigators
-
Francesco Castagnini, MD · IRCCS Istituto Ortopedico Rizzoli
Eligibility
- Min Age
- 18 Years
- Max Age
- 80 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-05-31
- Primary Completion
- 2025-06-30
- Completion
- 2025-07-01
Countries
- Italy
Study Locations
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