Frail ElderlyFRAKHNCT07086716
Frailty in Hip or Knee Arthroplasty Patients.
An observational study of Frail Elderly and Arthroplasties Hip Replacement, run by Joel Pollet at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Frail Elderly, Arthroplasties Hip Replacement, Arthroplasty Knee
- How many people
- 124 participants
- Where
- 1 siteItaly
- Study dates
- 3 Jun 2025to Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: We will include subjects that after an elective intervention of knee or hip arthroplasty are hospitalized in the thertiary refferal rehabilitation center where we are conducting the study.
Who may be able to join
- Received elective hip or knee arthroplasty;
- Ability to understand written and oral instructions;
- Gave consent to study participation.
Who cannot join
- Arthroplasty revision or not elective intervention;
- Participation in other studies;
- Hospitalized in the rehabilitation ward more then 10 days after surgery.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Centro "E. Spalenza - Don Gnocchi
Rovato, BS, 25038
Joel Pollet, 0307245282 ext. +39, jpollet@dongnocchi.it
About this study
Official title: The Role of Frailty in the Rehabilitation Pathway Following Hip or Knee Arthroplasty Surgery.
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.
Read the 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.
- Keywords
- Frailty, Hip, Knee, Arthroplasty, rehabilitation
- Medical subject headings
- Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Frail and Knee Arhtroplasty | Subjects with frailty before receiving knee arthroplasty | |
| Non-Frail and Knee Arhtroplasty | Subjects without frailty before receiving knee arthroplasty | |
| Frail and Hip Arhtroplasty | Subjects with frailty before receiving hip arthroplasty | |
| Non-Frail and Hip Arhtroplasty | Subjects without frailty before receiving hip arthroplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oxford Hip Score
It'a Patient Reported Outcome specific for patients that received Hip Arthroplasty. It investigates the field of autonomy, participation, and pain.
Measured: 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
It'a Patient Reported Outcome specific for patients that received Knee Arthroplasty. It investigates the field of autonomy, participation, and pain.
Measured: 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 outcomes (5)
modified Barthel Index
Investigates the ability of the included subjects to perform autonomously their Activities of Daily Living
Measured: Hospitalization or Day 1 (T0), to the discharge avarege Day 20 (T1).
Numerical Pain Raitng Scale
Provides a value of perceived pain from 0 to 10
Measured: 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
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.
Measured: 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
Rates the functioning of the knee joint, in subjects who underwent Knee arthroplasty
Measured: Hospitalization or Day 1 (T0), to the discharge avarege Day 20 (T1).
Merlè D'Aubigne-Postel Scale
Rates the functioning of the knee joint, in subjects who underwent Hip arthroplasty
Measured: Hospitalization or Day 1 (T0), to the discharge avarege Day 20 (T1).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2025
- Study start3 Jun 2025
- Primary completionJan 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Frail ElderlyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 124 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Joel Pollet
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Joel Pollet, Fondazione Don Carlo Gnocchi ETS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07086716
- Sponsor's protocol ID
- JP-004
- Acronym
- FRAKH
- Status last verified
- Jul 2025
- First submitted
- 8 Jul 2025
- Last updated
- 25 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We will upload the anonimazied database of the study in Zenodo (https://zenodo.org/), with a specific indication to the repository in the full-publication.
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Frailty in the Rehabilitation Pathway Following Hip or Knee Arthroplasty Surgery.
- ClinicalTrials.gov ID
- NCT07086716
- Acronym / sponsor ID
- FRAKH / JP-004
- Keywords
- Frailty, Hip, Knee, Arthroplasty, rehabilitation
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 124 participants (estimated)
- Lead sponsor
- Joel PolletUniversity, hospital or other
- Study start
- 3 Jun 2025 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 25 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Frail and Knee Arhtroplasty | – | –Subjects with frailty before receiving knee arthroplasty |
| Non-Frail and Knee Arhtroplasty | – | –Subjects without frailty before receiving knee arthroplasty |
| Frail and Hip Arhtroplasty | – | –Subjects with frailty before receiving hip arthroplasty |
| Non-Frail and Hip Arhtroplasty | – | –Subjects without frailty before receiving hip arthroplasty |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- We will include subjects that after an elective intervention of knee or hip arthroplasty are hospitalized in the thertiary refferal rehabilitation center where we are conducting the study.
Key inclusion criteria (3 listed)
- Received elective hip or knee arthroplasty;
- Ability to understand written and oral instructions;
- Gave consent to study participation.
Key exclusion criteria (3 listed)
- Arthroplasty revision or not elective intervention;
- Participation in other studies;
- Hospitalized in the rehabilitation ward more then 10 days after surgery.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
5 secondary outcomes
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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2025.
- Individual participant dataSharing planned: Yes. We will upload the anonimazied database of the study in Zenodo (https://zenodo.org/), with a specific indication to the repository in the full-publication.
Related trials for Frail Elderly
Recruiting
Comparıson of the Effıcacy of Conventıonal Exercıse and Pılates ın Pre-fraıl and Fraıl Older Adults
Frailty Syndrome, Prefrail Elderly
Active, not recruitingObservational study
Association of POCD With Circulating Biomarkers in Patients Undergoing TUR of Bladder Tumor
Cognitive Decline, Urinary Bladder Cancer
Not yet recruitingObservational study
Postprandial Hypotension, Frailty and Post-Induction Hypotension in Older Patients Undergoing Noncardiac Surgery
Post-induction Hypotension (PIH), Postprandial Hypotension
Active, not recruitingPhase 2
Chemoradiotherapy Versus Chemotherapy for Elderly and Frail GBM Patients
Glioblastoma Multiforme
Not yet recruiting
Effect of Animation-Based Digital Education on Risk Knowledge and Frailty in Older Adults
Aging, Frail Elderly
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Frail Elderly and Arthroplasties Hip Replacement, run by Joel Pollet at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Joel Pollet, PT, MSc, PhD (s) (3470439505 ext. +39, jpollet@dongnocchi.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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).). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jul 2025.