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OpenTrials
Completed

NCT Number: NCT07012577

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

SC Ortopedia e Traumatologia e Chirurgia Protesica e dei Reimpianti di Anca e Ginocchio, IRCCS Istituto Ortopedico Rizzoli

Bologna, Italy, 40136

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.).

Exclusion criteria

  • 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.

Treatment and study plan

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

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

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

Sponsors and collaborators

Lead sponsor

Istituto Ortopedico Rizzoli

Other

Registry information

Official study 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

Acronym: PAINGPT

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jun 10, 2025
Registry last updated
May 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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