Frailty in Hip or Knee Arthroplasty Patients. (FRAKH)

Joel Pollet

Status: Enrolling

Conditions: Arthroplasties Hip Replacement; Arthroplasty Knee; Frail Elderly

Study type: Observational

Funder types: Other

Identifiers

NCT07086716

JP-004

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 124 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

124 participants in 4 patient groups

Frail and Knee Arhtroplasty

Description:

Subjects with frailty before receiving knee arthroplasty

Non-Frail and Knee Arhtroplasty

Description:

Subjects without frailty before receiving knee arthroplasty

Frail and Hip Arhtroplasty

Description:

Subjects with frailty before receiving hip arthroplasty

Non-Frail and Hip Arhtroplasty

Description:

Subjects without frailty before receiving hip arthroplasty