Skip to content

Construction and Validation of a Multimodal Risk Prediction Model for Orthopedic Prosthesis-Associated Infection after Primary Arthroplasty

Construction and Validation of a Multimodal Risk Prediction Model for Orthopedic Prosthesis-Associated Infection after Primary Arthroplasty

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2600131343
Enrollment
Unknown
Registered
2026-09-01
Start date
2026-09-01
Completion date
Unknown
Last updated
2026-09-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

orthopedic prosthesis-associated infection(OPAI),periprosthetic joint infection(PJI)

Interventions

Sponsors

Shanghai Sixth People’s Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Age >= 18 years old; 2. Patients who have undergone orthopedic implant-related surgeries in our hospital and have been diagnosed with orthopedic implant-related infections, including but not limited to joint replacement prosthesis infection, fracture internal fixation infection, spinal internal fixation infection, and bone defect reconstruction material infection, etc. 3. The medical records, surgical reports, imaging data, laboratory tests, pathogen examinations, anti-infection treatments, and follow-up data are relatively complete and can be used to determine the diagnosis of infection, the treatment process, and the research outcome. 4. The infection diagnosis conforms to the clinical diagnostic criteria, or there are clear evidence of pathogenesis, imaging, intraoperative findings, histopathology, or comprehensive clinical evidence to support it. 5. The case data were sourced from the retrospective inclusion period as defined in this study.

Exclusion criteria

Exclusion criteria: 1. Infections related to non-surgical implant devices, such as simple soft tissue infections and non-device-related osteomyelitis, etc. 2. The type of implant, site of infection, operation time or time of infection cannot be clarified before surgery or in medical records; 3. The key clinical data are severely lacking, making it impossible to confirm the infection diagnosis, treatment process or main outcomes. 4. Unable to use their clinical data due to privacy protection, ethical requirements or data authorization restrictions; 5. The researchers determined other circumstances that were not suitable for inclusion in the analysis based on the medical records.

Design outcomes

Primary

MeasureTime frame
Osteonecrosis of the articular surface (OPAI) or periprosthetic joint infection (PJI) occurred within one year after orthopedic implant;Area Under the Receiver Operating Characteristic Curve;

Secondary

MeasureTime frame
Acute/early-onset infection within 90 days after surgery, delayed infection occurring 3-12 months after surgery, and long-term/blood-borne late-onset infection 12 months or later after surgery;Post-operative readmission, debridement, revision surgery, length of hospital stay, hospitalization cost and mortality events;Pathogen spectrum and drug resistance pattern;

Countries

China

Contacts

Public ContactXin Ma

Shanghai Sixth People’s Hospital

maxin@sh163.net+86 21 52888007

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Sep 19, 2026