Frailty in Hip or Knee Arthroplasty Patients.

NCT ID: NCT07086716

Last Updated: 2025-07-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

124 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-06-03

Study Completion Date

2027-12-31

Brief Summary

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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.

Detailed Description

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This study wanted to investigate the role of frailty in the rehabilitation path following hip or knee arthroplasty. Subjects will be divided according to the type of arthroplasty received (i.e., hip or knee arthroplasty). Consequently, each arthroplasty group will be divided into a frail group and a non-frail group based on the presence of frailty conditions before receiving surgery. Frailty condition will be assessed using the Primary Care Frailty Index, based on the information reported in each patient's medical record before surgery. Frailty level will be reassessed during the rehabilitation period, specifically at hospitalization in the rehabilitation ward (T0) and Discharge (T1). While other time points considered for the primary outcomes will be at 3-month follow-up (T2) and 1-year follow-up (T3), alongside the primary and secondary outcomes chosen for the study. The different outcomes considered in this study were selected to provide a wide range of information regarding body structure and function, activity level, and perceived level of satisfaction with the intervention. Moreover, the long-term follow-up will collect data on the adverse event rate, which previous studies have shown to significantly impact more frail subjects after receiving arthroplasty. However, the possible protective role of rehabilitation has never been considered. This prospective case-control study is the first to consider the crucial role of rehabilitation in the post-surgical path of subjects receiving arthroplasties. It can serve as a preliminary basis for further trials based on tailored interventions for frail subjects.

Conditions

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Frail Elderly Arthroplasties Hip Replacement Arthroplasty Knee

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Frail and Knee Arhtroplasty

Subjects with frailty before receiving knee arthroplasty

No interventions assigned to this group

Non-Frail and Knee Arhtroplasty

Subjects without frailty before receiving knee arthroplasty

No interventions assigned to this group

Frail and Hip Arhtroplasty

Subjects with frailty before receiving hip arthroplasty

No interventions assigned to this group

Non-Frail and Hip Arhtroplasty

Subjects without frailty before receiving hip arthroplasty

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

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

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Joel Pollet

OTHER

Sponsor Role lead

Responsible Party

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Joel Pollet

Principal Investigator

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Centro "E. Spalenza - Don Gnocchi

Rovato, BS, Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Joel Pollet, PT, MSc, PhD (s)

Role: CONTACT

3470439505 ext. +39

Facility Contacts

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Joel Pollet

Role: primary

0307245282 ext. +39

Other Identifiers

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JP-004

Identifier Type: -

Identifier Source: org_study_id

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