Frailty in Hip or Knee Arthroplasty Patients.

NCT07086716 | Recruiting

• 1 other identifier: JP-004
• Study Type: observational
• Target: 124
• Locations: 1 country
• Sites: 1

Brief Summary

The study aims to understand the existing differences between frail and non-frail subjects who underwent a rehabilitation path after receiving hip or knee arthroplasty surgery.

Conditions

Frail Elderly; Arthroplasties Hip Replacement; Arthroplasty Knee

Keywords

Frailty; Hip; Knee; Arthroplasty; rehabilitation

Outcome Measures

Primary Outcomes (2)

• Oxford Hip Score

  It'a Patient Reported Outcome specific for patients that received Hip Arthroplasty. It investigates the field of autonomy, participation, and pain.

  Hospitalization or Day 1 (T0), to the discharge avarege Day 20 (T1), till 3 months after surgery (T2), and 1 year after surgery(T3).

• Oxford Knee Score

  It'a Patient Reported Outcome specific for patients that received Knee Arthroplasty. It investigates the field of autonomy, participation, and pain.

  Hospitalization or Day 1 (T0), to the discharge avarege Day 20 (T1), till 3 months after surgery (T2), and 1 year after surgery(T3).

Secondary Outcomes (5)

• modified Barthel Index

  Hospitalization or Day 1 (T0), to the discharge avarege Day 20 (T1).

• Numerical Pain Raitng Scale

  Hospitalization or Day 1 (T0), to the discharge avarege Day 20 (T1), till 3 months after surgery (T2), and 1 year after surgery(T3).

• Adverse events

  Hospitalization or Day 1 (T0), to the discharge avarege Day 20 (T1), till 3 months after surgery (T2), and 1 year after surgery(T3).

• International Knee Society Rating System

  Hospitalization or Day 1 (T0), to the discharge avarege Day 20 (T1).

• Merlè D'Aubigne-Postel Scale

  Hospitalization or Day 1 (T0), to the discharge avarege Day 20 (T1).

Other Outcomes (8)

• Gait speed

  Hospitalization or Day 1 (T0), to the discharge avarege Day 20 (T1).

• Cadence

  Hospitalization or Day 1 (T0), to the discharge avarege Day 20 (T1).

• Gait cycle length

  Hospitalization or Day 1 (T0), to the discharge avarege Day 20 (T1).

Study Arms (4)

Frail and Knee Arhtroplasty

Subjects with frailty before receiving knee arthroplasty

Non-Frail and Knee Arhtroplasty

Subjects without frailty before receiving knee arthroplasty

Frail and Hip Arhtroplasty

Subjects with frailty before receiving hip arthroplasty

Non-Frail and Hip Arhtroplasty

Subjects without frailty before receiving hip arthroplasty

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

We will include subjects that after an elective intervention of knee or hip arthroplasty are hospitalized in the thertiary refferal rehabilitation center where we are conducting the study.

You may qualify if:

• Received elective hip or knee arthroplasty;
• Ability to understand written and oral instructions;
• Gave consent to study participation.

You may not qualify if:

• Arthroplasty revision or not elective intervention;
• Participation in other studies;
• Hospitalized in the rehabilitation ward more then 10 days after surgery.

Sponsors & Collaborators

• Joel Pollet: lead

Study Sites (1)

Centro "E. Spalenza - Don Gnocchi

Rovato, BS, 25038, Italy

RECRUITING

MeSH Terms

Conditions

Frailty

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Joel Pollet, PT, MSc, PhD (s)

CONTACT

3470439505; jpollet@dongnocchi.it

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 8, 2025
• First Posted: July 25, 2025
• Study Start: June 3, 2025
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: July 25, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Immediatly following the publication. No end date.
• Access Criteria: Anyone who wishes to access the data

Locations

IT (1)