Observational Study on AI Accuracy in Diagnosing and Treating Failed or Painful Hip Arthroplasty

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.

NCT Number	NCT07012577
Lead Sponsor	Istituto Ortopedico Rizzoli
Conditions	Total Hip Arthroplasty (THA)
Enrollment	20 participants
Start Date	2025-05-31
Primary Completion	2025-06-30 (estimated)
Study Completion	2025-07-01 (estimated)
Updated on ClinicalTrials.gov	2026-05-27