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Frailty in Hip or Knee Arthroplasty Patients.

The Role of Frailty in the Rehabilitation Pathway Following Hip or Knee Arthroplasty Surgery.

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07086716
Acronym
FRAKH
Enrollment
124
Registered
2025-07-25
Start date
2025-06-03
Completion date
2027-12-31
Last updated
2025-07-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Arthroplasties Hip Replacement, Arthroplasty Knee, Frail Elderly

Keywords

Frailty, Hip, Knee, Arthroplasty, rehabilitation

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.

Detailed 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.

Interventions

None listed

Sponsors

Joel Pollet
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Oxford Hip ScoreHospitalization or Day 1 (T0), to the discharge avarege Day 20 (T1), till 3 months after surgery (T2), and 1 year after surgery(T3).It'a Patient Reported Outcome specific for patients that received Hip Arthroplasty. It investigates the field of autonomy, participation, and pain.
Oxford Knee ScoreHospitalization or Day 1 (T0), to the discharge avarege Day 20 (T1), till 3 months after surgery (T2), and 1 year after surgery(T3).It'a Patient Reported Outcome specific for patients that received Knee Arthroplasty. It investigates the field of autonomy, participation, and pain.

Secondary

MeasureTime frameDescription
Adverse eventsHospitalization or Day 1 (T0), to the discharge avarege Day 20 (T1), till 3 months after surgery (T2), and 1 year after surgery(T3).Each adverse events, related to the arthroplasty, occuring to subjects involved in the study will be monitored, in particular: Death, arthroplasty dislocation, joint infection, reoperation, wound healing disorder, periprosthetic fracture, mechanical failure, and heterotopic ossification.
modified Barthel IndexHospitalization or Day 1 (T0), to the discharge avarege Day 20 (T1).Investigates the ability of the included subjects to perform autonomously their Activities of Daily Living
Merlè D'Aubigne-Postel ScaleHospitalization or Day 1 (T0), to the discharge avarege Day 20 (T1).Rates the functioning of the knee joint, in subjects who underwent Hip arthroplasty
International Knee Society Rating SystemHospitalization or Day 1 (T0), to the discharge avarege Day 20 (T1).Rates the functioning of the knee joint, in subjects who underwent Knee arthroplasty
Numerical Pain Raitng ScaleHospitalization or Day 1 (T0), to the discharge avarege Day 20 (T1), till 3 months after surgery (T2), and 1 year after surgery(T3).Provides a value of perceived pain from 0 to 10

Other

MeasureTime frameDescription
Gait cycle lengthHospitalization or Day 1 (T0), to the discharge avarege Day 20 (T1).Step length recorded during gait analysis
Gait Deviation IndexHospitalization or Day 1 (T0), to the discharge avarege Day 20 (T1).Provides the deviation rate from physiological gait.
Gait cycle durationHospitalization or Day 1 (T0), to the discharge avarege Day 20 (T1).Step duration recorded during gait analysis
Gait Profile ScoreHospitalization or Day 1 (T0), to the discharge avarege Day 20 (T1).A gait summary measure that indicates the deviation from a physiological gait
Step subphases durationHospitalization or Day 1 (T0), to the discharge avarege Day 20 (T1).Duration of single stance, double stance and swing phase recorded through gait analysis.
Gait speedHospitalization or Day 1 (T0), to the discharge avarege Day 20 (T1).Gait speed recorded during gait analysis
CadenceHospitalization or Day 1 (T0), to the discharge avarege Day 20 (T1).Step cadence recorded during gait analysis
Gait Variable ScoreHospitalization or Day 1 (T0), to the discharge avarege Day 20 (T1).A gait summary measure that indicates the deviation from physiological motion in the main joint plains of movement.

Countries

Italy

Contacts

Primary ContactJoel Pollet, PT, MSc, PhD (s)
jpollet@dongnocchi.it3470439505

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026