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A Machine Learning Model Based on Preoperative Fecal 16S rRNA Sequencing and Raman Spectroscopy Multi-Omics Features for Predicting Chronic Pain After Total Knee Arthroplasty

A Prospective Cohort Study of a Machine Learning Model Based on Preoperative Fecal 16S rRNA Sequencing and Raman Spectroscopy Multi-Omics Features for Predicting Chronic Postsurgical Pain After Total Knee Arthroplasty

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2600123915
Enrollment
Unknown
Registered
2026-04-30
Start date
2026-05-05
Completion date
Unknown
Last updated
2026-05-04

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

Conditions

Chronic pain after total knee arthroplasty

Interventions

Observational cohort group:None

Sponsors

Handan Central Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Diagnosed with knee osteoarthritis and scheduled for primary unilateral total knee arthroplasty; 2. Age >= 18 years; 3. Able to provide preoperative fecal samples; 4. Able to complete postoperative follow-up; 5. Complete clinical data available

Exclusion criteria

Exclusion criteria: 1. Use of antibiotics, probiotics, prebiotics, or other drugs affecting gut microbiota within 4 weeks; 2. Presence of inflammatory bowel disease, severe infection, malignancy, autoimmune disease, or severe hepatic/renal dysfunction; 3. Previous revision or major lower limb surgery on the affected side; 4. Severe psychiatric or cognitive impairment preventing accurate pain assessment; 5. Postoperative mechanical complications such as infection, prosthesis loosening, instability, or fracture; 6. Inadequate sample quality or failed 16S/Raman testing; 7. Loss to follow-up.

Design outcomes

Primary

MeasureTime frame
Occurrence of chronic pain after total knee arthroplasty;

Secondary

MeasureTime frame
Knee function scores (KSS or WOMAC);Preoperative gut microbiota features (16S rRNA sequencing);Preoperative Raman spectroscopy features;

Countries

China

Contacts

Public ContactShihuan Chen

Handan Central Hospital

1373680424@qq.com+86 176 3103 7717

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: May 7, 2026