CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 20 enrolled
Drug / intervention
GPT-4 Assessment +3 moreother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT07012577
NCT07012577N/ACompleted

Observational Study on the Accuracy and Completeness of General Artificial Intelligence in the Diagnosis and Therapeutic Recommendations for Failed or Painful Total Hip Arthroplasty

Istituto Ortopedico Rizzoli·observational·Posted Jun 10, 2025·Updated May 27, 2026

In Brief

An observational study evaluating GPT-4 Assessment, Arthroplasty Fellow Assessment, and 2 other interventions for Total Hip Arthroplasty (THA). Completed, enrolled 20 participants across 1 site.

Detailed 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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesItaly
Collaborators--

Timeline

N/ACompletedFinished
2026
First PostedJun 10, 2025
Enrollment StartMay 31, 2025
Primary CompletionJun 30, 2025
Study CompletionJul 1, 2025
TodayJul 2, 2026
Enrollment to primary: 29 daysPosted 1.1 years ago

Interventions

GPT-4 Assessmentother

Diagnostic/Prognostic evaluation of any single case provided by AI (GPT-4). GPT-4 provides diagnosis/treatment recommendations via standardized prompts

Arthroplasty Fellow Assessmentother

Diagnostic/Prognostic evaluation of any single case provided by an human expert

Specializing Resident (4th year) Assessmentother

Diagnostic/Prognostic evaluation of any single case provided by an human expert

Junior Resident (3rd year) Assessmentother

Diagnostic/Prognostic evaluation of any single case provided by an human expert