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NCT Number: NCT07086716

Frailty in Hip or Knee Arthroplasty Patients.

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Centro "E. Spalenza - Don Gnocchi

Rovato, BS, 25038, Italy

Location status: Recruiting

Location contact

Joel Pollet

CONTACT

[email protected]

0307245282 ext. +39

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Oxford Hip Score

    Time frame: Hospitalization 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.

  2. Oxford Knee Score

    Time frame: Hospitalization 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 outcomes

  1. modified Barthel Index

    Time frame: Hospitalization 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

  2. Numerical Pain Raitng Scale

    Time frame: Hospitalization 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

  3. Adverse events

    Time frame: Hospitalization 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.

  4. International Knee Society Rating System

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

    Rates the functioning of the knee joint, in subjects who underwent Knee arthroplasty

  5. Merlè D'Aubigne-Postel Scale

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

    Rates the functioning of the knee joint, in subjects who underwent Hip arthroplasty

Other outcomes

  1. Gait speed

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

    Gait speed recorded during gait analysis

  2. Cadence

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

    Step cadence recorded during gait analysis

  3. Gait cycle length

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

    Step length recorded during gait analysis

  4. Gait cycle duration

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

    Step duration recorded during gait analysis

  5. Step subphases duration

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

    Duration of single stance, double stance and swing phase recorded through gait analysis.

  6. Gait Profile Score

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

    A gait summary measure that indicates the deviation from a physiological gait

  7. Gait Variable Score

    Time frame: Hospitalization 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.

  8. Gait Deviation Index

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

    Provides the deviation rate from physiological gait.

Study contacts

Contact information is provided by the study sponsor or research team.

Joel Pollet, PT, MSc, PhD (s)

CONTACT

[email protected]

3470439505 ext. +39

Sponsors and collaborators

Lead sponsor

Joel Pollet

Other

Registry information

Official study title

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

Acronym: FRAKH

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jul 25, 2025
Registry last updated
Jul 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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