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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Failed or Painful Total Hip Arthroplasty Patients | Patients with documented failed/painful THA (aseptic loosening, infection, fracture, etc.) selected from a tertiary center database (2004-2024). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GPT-4 Assessment | Other | Diagnostic/Prognostic evaluation of any single case provided by AI (GPT-4). GPT-4 provides diagnosis/treatment recommendations via standardized prompts |
|
| Measure | Description | Time Frame |
|---|---|---|
| Diagnostic correctness | Proportion of fully correct diagnoses (score=2) by each rater, Scale 0 (worst outcome) - 2 (best outcome). 0: incorrect, 1: imprecise, 2: correct | Immediate (post-case evaluation) |
| Diagnostic completeness | Proportion of fully complete diagnoses (score=2). Scale 0 (worst outcome) - 2 (best outcome). 0: incomplete, 1: partially complete, 2: complete | Immediate (post-case evaluation) |
| Treatment recommendation correctness | Proportion of fully correct treatments (score=2) by each rater. Scale 0 (worst outcome) - 2 (best outcome). 0: incorrect, 1: imprecise, 2: correct | Immediate (post-case evaluation) |
| Treatmetn recommendation completeness | Proportion of fully complete treatments (score=2). Scale 0 (worst outcome) - 2 (best outcome). 0: incomplete, 1: partially complete, 2: complete | Immediate (post-case evaluation) |
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Inclusion Criteria:
Exclusion Criteria:
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This study evaluated 20 anonymized cases of failed/painful total hip arthroplasty (2004-2024) from a tertiary center. Cases were selected for diagnostic clarity (e.g., aseptic loosening, periprosthetic fracture) and excluded if records were incomplete or ambiguous. Two senior surgeons verified case eligibility. Each case was assessed by GPT-4, an arthroplasty fellow, a 4th-year resident, and a 3rd-year resident for diagnostic/therapeutic accuracy.
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| Name | Affiliation | Role |
|---|---|---|
| Francesco Castagnini, MD | IRCCS Istituto Ortopedico Rizzoli | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| SC Ortopedia e Traumatologia e Chirurgia Protesica e dei Reimpianti di Anca e Ginocchio, IRCCS Istituto Ortopedico Rizzoli | Bologna | Italy | 40136 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38967407 | Background | Knee CJ, Campbell RJ, Graham DJ, Handford C, Symes M, Sivakumar BS. Examining the role of ChatGPT in the management of distal radius fractures: insights into its accuracy and consistency. ANZ J Surg. 2024 Jul-Aug;94(7-8):1391-1396. doi: 10.1111/ans.19143. Epub 2024 Jul 5. | |
| 39246048 | Background | Dagher T, Dwyer EP, Baker HP, Kalidoss S, Strelzow JA. "Dr. AI Will See You Now": How Do ChatGPT-4 Treatment Recommendations Align With Orthopaedic Clinical Practice Guidelines? Clin Orthop Relat Res. 2024 Dec 1;482(12):2098-2106. doi: 10.1097/CORR.0000000000003234. Epub 2024 Sep 6. |
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Rater evaluations on clinical cases; no direct patient data are included; all datasets are anonymized and do not allow identification.
Immediately upon publication. Access limit: indefinitely
With researchers, clinicians, or institutions upon request or directly via public repository.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 25, 2026 |
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| Arthroplasty Fellow Assessment | Other | Diagnostic/Prognostic evaluation of any single case provided by an human expert |
|
| Specializing Resident (4th year) Assessment | Other | Diagnostic/Prognostic evaluation of any single case provided by an human expert |
|
| Junior Resident (3rd year) Assessment | Other | Diagnostic/Prognostic evaluation of any single case provided by an human expert |
|
| 39741912 | Background | Artioli E, Veronesi F, Mazzotti A, Brogini S, Zielli SO, Giavaresi G, Faldini C. Assessing ChatGPT responses to common patient questions regarding total ankle arthroplasty. J Exp Orthop. 2024 Dec 31;12(1):e70138. doi: 10.1002/jeo2.70138. eCollection 2025 Jan. |
| 39850460 | Background | Pagano S, Strumolo L, Michalk K, Schiegl J, Pulido LC, Reinhard J, Maderbacher G, Renkawitz T, Schuster M. Evaluating ChatGPT, Gemini and other Large Language Models (LLMs) in orthopaedic diagnostics: A prospective clinical study. Comput Struct Biotechnol J. 2024 Dec 26;28:9-15. doi: 10.1016/j.csbj.2024.12.013. eCollection 2025. |
| May 25, 2026 |
| Prot_SAP_001.pdf |
| ID | Term |
|---|---|
| D004194 | Disease |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D012149 | Restraint, Physical |
| ID | Term |
|---|---|
| D032763 | Behavior Control |
| D013812 | Therapeutics |
| D007103 | Immobilization |
| D008919 | Investigative Techniques |
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