Total Hip Arthroplasty (THA)PAINGPTNCT07012577
Observational Study on AI Accuracy in Diagnosing and Treating Failed or Painful Hip Arthroplasty
An observational study of Total Hip Arthroplasty (THA), run by Istituto Ortopedico Rizzoli at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Total Hip Arthroplasty (THA)
- What is being tested?
- GPT-4 Assessment, Arthroplasty Fellow Assessment and Specializing Resident (4th year) Assessment
- How many people
- 20 participants
- Where
- 1 siteItaly
- Study dates
- 31 May 2025to 1 Jul 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- Adults (≥18 and ≤80 years old).
- Documented painful or failed total hip arthroplasty requiring clinical/radiological evaluation (2004-2024).
- Complete pre-operative clinical history, imaging (X-ray/tomography), and surgical reports.
- Clear diagnosis of failure mode (e.g., aseptic loosening, infection, fracture, wear).
- Treatment and outcomes fully documented in the institutional database.
- "Exemplary" cases with minimal diagnostic ambiguity (per Engh/MusculoSkleletal Infection Society criteria, etc.).
Who cannot join
- total hip arthroplasty with no documented failure/pain (well-functioning implants).
- Incomplete clinical/radiological records (e.g., missing pre-operative imaging or surgical notes).
- Complex/multifactorial failures (e.g., concurrent infection + loosening + fracture).
- Radiographs/images non-interpretable (poor quality, missing views).
- Cases with conflicting diagnoses/treatments in original records.
Trial locations and contacts
1 site in 1 country.
Italy1 site
SC Ortopedia e Traumatologia e Chirurgia Protesica e dei Reimpianti di Anca e Ginocchio, IRCCS Istituto Ortopedico Rizzoli
Bologna, Italy, 40136
About this study
Official title: Observational Study on the Accuracy and Completeness of General Artificial Intelligence in the Diagnosis and Therapeutic Recommendations for Failed or Painful Total 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.
Read more
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)
- Being tested
- GPT-4 Assessment, Arthroplasty Fellow Assessment, Specializing Resident (4th year) Assessment, Junior Resident (3rd year) Assessment
- Keywords
- Artificial intelligence, total hip arthroplasty, diagnosis, treatment
- Medical subject headings
- Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Other: GPT-4 Assessment; Other: Arthroplasty Fellow Assessment; Other: Specializing Resident (4th year) Assessment; Other: Junior Resident (3rd year) Assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
Measured: Immediate (post-case evaluation)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2025
- Study start31 May 2025
- Primary completion30 Jun 2025
- Study completion1 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Total Hip Arthroplasty (THA)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istituto Ortopedico Rizzoli
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, francesco castagnini, Istituto Ortopedico Rizzoli
- Investigators
- Francesco Castagnini, MD, Principal investigator, IRCCS Istituto Ortopedico Rizzoli
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07012577
- Sponsor's protocol ID
- 203/2025/Oss/IOR
- Acronym
- PAINGPT
- Status last verified
- May 2026
- First submitted
- 31 May 2025
- Last updated
- 27 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Rater evaluations on clinical cases; no direct patient data are included; all datasets are anonymized and do not allow identification.
Publications
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.
PubMed 38967407Dagher 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.
PubMed 39246048Artioli 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.
PubMed 39741912Pagano 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.
PubMed 39850460
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study on the Accuracy and Completeness of General Artificial Intelligence in the Diagnosis and Therapeutic Recommendations for Failed or Painful Total Hip Arthroplasty
- ClinicalTrials.gov ID
- NCT07012577
- Acronym / sponsor ID
- PAINGPT / 203/2025/Oss/IOR
- Conditions
- Total Hip Arthroplasty (THA)
- Keywords
- Artificial intelligence, total hip arthroplasty, diagnosis, treatment
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Istituto Ortopedico RizzoliUniversity, hospital or other
- Study start
- 31 May 2025 (actual)
- Primary completion
- 30 Jun 2025 (actual)
- Study completion
- 1 Jul 2025 (actual)
- First posted
- 10 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Failed or Painful Total Hip Arthroplasty Patients | – | Other: GPT-4 Assessment, Other: Arthroplasty Fellow Assessment, Other: Specializing Resident (4th year) Assessment, Other: Junior Resident (3rd year) AssessmentPatients with documented failed/painful THA (aseptic loosening, infection, fracture, etc.) selected from a tertiary center database (2004-2024). |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (6 listed)
- Adults (≥18 and ≤80 years old).
- Documented painful or failed total hip arthroplasty requiring clinical/radiological evaluation (2004-2024).
- Complete pre-operative clinical history, imaging (X-ray/tomography), and surgical reports.
- Clear diagnosis of failure mode (e.g., aseptic loosening, infection, fracture, wear).
- Treatment and outcomes fully documented in the institutional database.
Key exclusion criteria (5 listed)
- total hip arthroplasty with no documented failure/pain (well-functioning implants).
- Incomplete clinical/radiological records (e.g., missing pre-operative imaging or surgical notes).
- Complex/multifactorial failures (e.g., concurrent infection + loosening + fracture).
- Radiographs/images non-interpretable (poor quality, missing views).
- Cases with conflicting diagnoses/treatments in original records.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GPT-4 AssessmentDiagnostic/Prognostic evaluation of any single case provided by AI (GPT-4). GPT-4 provides diagnosis/treatment recommendations via standardized prompts | Other | Failed or Painful Total Hip Arthroplasty Patients |
| Arthroplasty Fellow AssessmentDiagnostic/Prognostic evaluation of any single case provided by an human expert | Other | Failed or Painful Total Hip Arthroplasty Patients |
| Specializing Resident (4th year) AssessmentDiagnostic/Prognostic evaluation of any single case provided by an human expert | Other | Failed or Painful Total Hip Arthroplasty Patients |
| Junior Resident (3rd year) AssessmentDiagnostic/Prognostic evaluation of any single case provided by an human expert | Other | Failed or Painful Total Hip Arthroplasty Patients |
Primary outcome
Diagnostic correctness
Time frame: Immediate (post-case evaluation)
Proportion of fully correct diagnoses (score=2) by each rater, Scale 0 (worst outcome) - 2 (best outcome). 0: incorrect, 1: imprecise, 2: correct
Diagnostic completeness
Time frame: Immediate (post-case evaluation)
Proportion of fully complete diagnoses (score=2). Scale 0 (worst outcome) - 2 (best outcome). 0: incomplete, 1: partially complete, 2: complete
Treatment recommendation correctness
Time frame: Immediate (post-case evaluation)
Proportion of fully correct treatments (score=2) by each rater. Scale 0 (worst outcome) - 2 (best outcome). 0: incorrect, 1: imprecise, 2: correct
Treatmetn recommendation completeness
Time frame: Immediate (post-case evaluation)
Proportion of fully complete treatments (score=2). Scale 0 (worst outcome) - 2 (best outcome). 0: incomplete, 1: partially complete, 2: complete
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2026.
- Background: PubMed 38967407Knee 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.
- Background: PubMed 39246048Dagher 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.
- Background: PubMed 39741912Artioli 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.
- Background: PubMed 39850460Pagano 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.
- Individual participant dataSharing planned: Yes. Rater evaluations on clinical cases; no direct patient data are included; all datasets are anonymized and do not allow identification.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Francesco Castagnini, MD principal investigator
IRCCS Istituto Ortopedico Rizzoli
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Total Hip Arthroplasty (THA), run by Istituto Ortopedico Rizzoli at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic correctness (time frame: Immediate (post-case evaluation)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07012577, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 May 2026.