Actively Recruiting

Age: 18Years +
All Genders
ID07333560

Development and Pre-validated Multiple Variable Prediction Model Using Machine Learning for Early Functional Recovery After Joint Replacement Surgery

Led by Istituto Ortopedico Rizzoli · Updated on 2026-06-01

943

Participants Needed

2

Research Sites

N/A

Total Duration

On this page

Sponsors

I

Istituto Ortopedico Rizzoli

Lead Sponsor

A

Azienda U.S.L. - IRCCS di Reggio Emilia

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers aim to develop and test a machine learning algorithm that predicts early recovery of mobility and hospital length of stay in patients who have undergone elective hip or knee joint replacement surgery. The study includes both retrospective data from 2020 to 2023 and prospective data collected from March 2026 to December 2027. The primary question is whether the model can accurately classify patients with faster versus slower recovery of autonomous mobility shortly after surgery. The study uses clinical and perioperative data from patients who received post-operative physiotherapy. The machine learning model will be trained on retrospective data and then evaluated on prospectively collected data to assess its predictive accuracy. Several algorithms like logistic regression, random forest, and gradient boosting will be compared. The model's performance will be measured by statistical metrics including the area under the receiver operating characteristic curve (AUROC), precision, and calibration plots. Participants' recovery will be assessed by their ability to climb stairs within the first four days after surgery, as recorded in physiotherapy diaries and health records. Length of hospital stay is tracked, with discharge by day five considered regular. Data collection includes demographics, surgical details, pain levels, and other clinical factors. Predictive results are stored separately and do not affect clinical care. The study involves two phases with a total of 943 patients and will monitor model performance over approximately two years.

CONDITIONS

Brief Title

Development and Pre-validation of a Machine Learning-based Prediction Algorithm for Early Functional Recovery in Patients Undergoing Hip and Knee Replacement Surgery

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults aged 18 years or older
  • Patients who underwent elective hip or knee arthroplasty
  • Patients who started postoperative physiotherapy
Not Eligible

You will not qualify if you...

  • Patients who had surgery for oncologic disease, femoral fracture, or revision joint arthroplasty
  • Patients who did not receive postoperative physiotherapy due to complications
  • Patients with unavailable clinical data

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Monitoring

Duration - Up to 5 days post surgery

Participants who undergo routine care are observed. Measurements such as mobility recovery and hospital length of stay are collected from physiotherapy diaries and electronic health records during the immediate postoperative period.

1 to 3 visits depending on physiotherapy sessions

Long-term Monitoring

Duration - Up to 2 years

Participants are monitored prospectively to validate the predictive model using routine clinical data without affecting their treatment.

Data collected through routine clinical care with no additional visits required

Trial Site Locations

Total: 2 locations

1

SAITeR IRCCS Istituto Ortopedico Rizzoli

Bologna, Italy, 40100

Actively Recruiting

2

Azienda U.S.L. - IRCCS di Reggio Emilia

Reggio Emilia, Italy

Not Yet Recruiting

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Research Team

M

Mattia Morri

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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Published Research Related To This Trial

Joint replacement surgery in elderly patients with severe osteoarthritis of the hip or knee: decision making, postoperative recovery, and clinical outcomes.

Mary Beth Hamel, Maria Toth, Anna Legedza...

https://pubmed.ncbi.nlm.nih.gov/18625924

Receiver operating characteristic curve analysis in diagnostic accuracy studies: A guide to interpreting the area under the curve value.

Şeref Kerem Çorbacıoğlu, Gökhan Aksel

https://pubmed.ncbi.nlm.nih.gov/38024184

Artificial intelligence in disease diagnostics: a comprehensive narrative review of current advances, applications, and future challenges in healthcare.

Mohamed Baklola, Reem Reda Elmahdi, Shaimaa Ali...

https://pubmed.ncbi.nlm.nih.gov/40851938