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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorIstituto Ortopedico Rizzoli

About this trial

The goal of this observational study is to develop and pre-validate a machine learning algorithm to predict early recovery of mobility in patients undergoing hip or knee joint replacement surgery. The primary research question is:

Can a machine learning model accurately classify patients with faster versus slower recovery of autonomous mobility in the first days after joint replacement surgery?

Patients who have undergone elective hip or knee arthroplasty and received post-operative physiotherapy will have their clinical and perioperative data collected retrospectively (2020-2023) and prospectively (March 2026-December 2027). The algorithm will be trained on retrospective data and tested prospectively to evaluate its predictive performance for early mobilization and length of hospital stay.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adults aged 18 years or older

Patients underwent elective hip or knee arthroplasty.

Patients for whom postoperative physiotherapy was initiated.

Disqualifiers

Patients who underwent surgery for oncologic disease, femoral fracture, or revision joint arthroplasty.

Patients for whom postoperative physiotherapy was not provided due to postoperative complications

clinical data are unavailable.

Trial population

For the retrospective phase, data will be extracted from existing clinical and research databases at IRCCS Istituto Ortopedico Rizzoli. Pre-existing data collected between 2020 and 2023 will be used to develop automated predictive models. For the prospective phase, patients admitted to IRCCS Istituto Ortopedico Rizzoli for elective hip or knee arthroplasty between March 2026 and December 2027 will be consecutively enrolled. Newly collected data will be used to externally validate the predictive model, which will be applied without any modification (locked model).

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Predictive Model for Early Mobility Recovery and Length of Stay

    Other intervention

    Application of a machine learning-based predictive algorithm to retrospectively and prospectively analyze clinical and perioperative data in patients undergoing hip or knee arthroplasty, without influencing clinical decision-making.

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

1

Area under the receiver operating characteristic curve (AUROC) for discrimination ability of the machine learning predictive model

The discrimination ability of the machine learning predictive model will be assessed using the area under the receiver operating characteristic curve (AUROC). AUROC summarizes the trade-off between sensitivity and specificity across all possible classification thresholds. AUROC values range from 0.5 (no discrimination) to 1.0 (perfect discrimination). Higher values indicate better model performance. Values above 0.8 will be considered indicative of good discriminatory performance.

Time frame
Through study completion, an average of 2 years

Secondary outcomes

1

Calibration of the machine learning predictive model assessed by calibration plots

Agreement between predicted probabilities and observed outcomes will be evaluated using calibration plots. Calibration will be visually assessed by plotting predicted versus observed event probabilities.

Time frame
through study completion, an average of 2 years
2

Predictive performance of the machine learning model assessed by precision and F1-score

Predictive performance will be evaluated using precision and F1-score derived from the confusion matrix by comparing predicted class labels with observed outcomes. Precision reflects the proportion of correctly predicted positive cases among all predicted positives. The F1-score represents the harmonic mean of precision and recall. Higher values indicate better predictive performance.

Time frame
Through study completion, an average of 2 years

Other outcomes

Sponsors and contacts

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Istituto Ortopedico Rizzoli

Lead sponsor

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

Collaborator