Evaluation of Musculoskeletal Aging and Related Disorders Via Advanced Clinical Imaging

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorPeking University People's Hospital

About this trial

Study Overview This clinical research focuses on the development and validation of a multimodal artificial intelligence (AI) platform designed for the automated diagnosis and precise staging of two major musculoskeletal conditions: Osteoporosis (OP) and Osteoarthritis (OA). By integrating diverse clinical imaging data, the study aims to provide a more objective and standardized approach to assessing bone and joint degeneration.

Technological Core: Intelligent Staging

Traditional diagnosis often relies on manual interpretation, which can lead to inter-observer variability. This study employs deep learning and multimodal imaging to:

For Osteoporosis: Automatically quantify bone mineral density and micro-architectural changes to determine the stage of bone loss and evaluate fracture risk.

For Osteoarthritis: Identify subtle radiological markers such as joint space narrowing and osteophyte formation to categorize the severity of joint degeneration according to international staging standards (e.g., Kellgren-Lawrence scale).

Why This Matters Early Intervention: By identifying early-stage changes in bone density and joint integrity, clinicians can implement preventive treatments before significant disability occurs.

Standardized Care: The intelligent diagnostic model provides a "digital second opinion," ensuring consistent staging across different healthcare settings.

Efficiency: The automated workflow reduces the workload of radiologists while maintaining high diagnostic accuracy.

Ethical Compliance The study is conducted at Peking University People's Hospital under the supervision of the Institutional Review Board (Approval No. 2026PHB097-001). It strictly adheres to international ethical standards, including the Declaration of Helsinki and Good Clinical Practice (GCP) guidelines, to ensure patient data privacy and safety.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Age: Adults aged at least 18 years.

Gender: No gender restrictions; both male and female participants are eligible.

Imaging Data: Participants must have completed relevant clinical imaging scans of skeletal sites, including but not limited to X-ray, CT (plain scan), or MRI (plain scan).

Anatomical Integrity: The skeletal structure of the target area must be free from congenital or acquired deformities.

Disqualifiers

Pathological History: Patients with a history of prior pathological fractures.

Malignancy: Patients seeking treatment or diagnosed with bone tumors or other systemic malignancies.

Medication History: Patients with a history of long-term steroid use, which may significantly affect bone density and joint structure.

Recent Treatment: Patients who have undergone radiotherapy or chemotherapy within the past six months.

Trial population

Study Population DescriptionThe study population consists of adult patients seeking medical consultation or treatment at the Department of Orthopaedic Trauma, Peking University People's Hospital. This population represents a diverse clinical spectrum of musculoskeletal aging, ranging from healthy skeletal status to various stages of Osteoporosis (OP) and Osteoarthritis (OA).The research employs a bidirectional cohort structure:Retrospective Cohort: Includes approximately 1,500 patients treated between November 2005 and November 2025, primarily used for model training and internal algorithm validation.Prospective Cohort: Includes at least 500 patients recruited starting from December 2025, used for independent external validation of the model's diagnostic accuracy and staging robustness in a real-world clinical setting.Participants are characterized by their availability of multimodal data, including radiological images (X-ray, CT, MRI) and clinical laboratory indicators (e.g., bone tur

Trial design

Design model

Cohort

Time perspective

Cross-sectional

Treatments tested in this trial

  • No Interventions

    Other intervention

    No Interventions

Treatment groups

2,000 Participants
are divided into 6 treatment groups

6

Treatment groups

See each treatment group below.

Group A: Peking University People's Hospital cohort 11 intervention
Group B: Peking University People's Hospital cohort 21 intervention
Group C: Sun yat-sen memorial hospital 11 intervention
Group D: Sun yat-sen memorial hospital 21 intervention
Group E: Peking University People's Hospital cohort 31 intervention
Group F: Sun yat-sen memorial hospital 31 intervention

Trial outcomes

Primary outcomes

1

Bone age status

Bone mineral density and osteoarthitis

Time frame
From enrollment to the initial treatment at 2 years

Secondary outcomes

Other outcomes

Sponsors and contacts

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