Health TrialsbyHealthPanel

Prepare II - Predictive Model Training and External Validation

ConditionHIP AND KNEE OSTEOARTHRITIS
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorI.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio

About this trial

The general aim of the project is training and testing a predictive model of inpatient rehabilitation stay after hip and knee replacement for osteoarthritis. This specific part focuses on data collection and analysis for the model validation.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients admitted for THR and TKR at IRCCS Galeazzi Orthopedic Institute in 2018 (any month) and subsequently discharged to inpatient rehabilitation in the same structure.

Aged ≥18 years.

International Classification of Disease, Ninth Revision, Clinical Modification (ICD-9CM) Diagnoses: 715.15, 16, 25, 26 (primary and secondary osteoarthritis of the hip and knee).

ICD-9CM Surgical procedures: 81.51, 81.54 (total joint replacement of the hip and knee).

Disqualifiers

Age < 18 years (if any).

Trial population

Patients admitted to inpatient rehabilitation unit after discharged from surgical ward.

Trial design

Design model

Cohort

Time perspective

Retrospective

Treatments tested in this trial

  • Functional rehabilitation

    Other intervention

    Functional rehabilitation is standardized educational and physical therapy to restore physical and activities of daily living function before discharge. Pain management, blood management and iron diet are also provided based on standard conditions (e.g. patient-reported pain, postoperative day and hemoglobin levels).

Treatment groups

400 Participants
are divided into 1 treatment group
Group A: Patients who underwent total hip and/or knee arthroplasty for primary or secondary osteoarthirtis1 intervention

Trial outcomes

Primary outcomes

1

Length of inpatient rehabilitation stay (days)

The number of days needed by the patient to be discharged in safety

Time frame
Up to 30 days

Secondary outcomes

1

Need of care at discharge

Hours of care (number) needed by the patient (estimation) to receive support on the Activities of Daily Living after hospital discharge.

Time frame
Last day of inpatient rehabilitation stay: up to 30 days
2

Place of discharge

Home, home with care givers, other inpatient unit.

Time frame
Last day of inpatient rehabilitation stay: up to 30 days.
3

Barthel Index of autonomy in Activities of Daily Living (ADL)

Score 0-100 in both scales.

Time frame
Last day of inpatient rehabilitation stay: up to 30 days.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio

Lead sponsor

Source ClinicalTrials.gov
Apply now