Frailty in Hip or Knee Arthroplasty Patients.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Frail Elderly, Arthroplasties Hip Replacement, Arthroplasty Knee. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
The Role of Frailty in the Rehabilitation Pathway Following Hip or Knee Arthroplasty Surgery.
Overview
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.
Primary outcome measures
- 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).]
- 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).]
Secondary outcome measures (5)
- modified Barthel Index [Time frame: Hospitalization or Day 1 (T0), to the discharge avarege Day 20 (T1).]
- 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).]
- 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).]
- International Knee Society Rating System [Time frame: Hospitalization or Day 1 (T0), to the discharge avarege Day 20 (T1).]
- Merlè D'Aubigne-Postel Scale [Time frame: Hospitalization or Day 1 (T0), to the discharge avarege Day 20 (T1).]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-control
Study locations
Italy · 1 center
- Centro "E. Spalenza - Don Gnocchi — Rovato
Identifiers
NCT: NCT07086716 · JP-004