Frailty in Hip or Knee Arthroplasty Patients.
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorJoel Pollet
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Received elective hip or knee arthroplasty;
Ability to understand written and oral instructions;
Gave consent to study participation.
Disqualifiers
Arthroplasty revision or not elective intervention;
Participation in other studies;
Hospitalized in the rehabilitation ward more then 10 days after surgery.
Trial 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.
Trial design
Design model
Case-control
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
124 Participants
are grouped into 4 trial groupsGroup A: Frail and Knee Arhtroplasty
Group B: Non-Frail and Knee Arhtroplasty
Group C: Frail and Hip Arhtroplasty
Group D: Non-Frail and Hip Arhtroplasty
Trial outcomes
Primary outcomes
1
Oxford Hip Score
It'a Patient Reported Outcome specific for patients that received Hip Arthroplasty. It investigates the field of autonomy, participation, and pain.
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).2
Oxford Knee Score
It'a Patient Reported Outcome specific for patients that received Knee Arthroplasty. It investigates the field of autonomy, participation, and pain.
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 outcomes
1
modified Barthel Index
Investigates the ability of the included subjects to perform autonomously their Activities of Daily Living
Time frame
Hospitalization or Day 1 (T0), to the discharge avarege Day 20 (T1).2
Numerical Pain Raitng Scale
Provides a value of perceived pain from 0 to 10
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).3
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.
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).4
International Knee Society Rating System
Rates the functioning of the knee joint, in subjects who underwent Knee arthroplasty
Time frame
Hospitalization or Day 1 (T0), to the discharge avarege Day 20 (T1).Other outcomes
1
Gait speed
Gait speed recorded during gait analysis
Time frame
Hospitalization or Day 1 (T0), to the discharge avarege Day 20 (T1).2
Cadence
Step cadence recorded during gait analysis
Time frame
Hospitalization or Day 1 (T0), to the discharge avarege Day 20 (T1).3
Gait cycle length
Step length recorded during gait analysis
Time frame
Hospitalization or Day 1 (T0), to the discharge avarege Day 20 (T1).4
Gait cycle duration
Step duration recorded during gait analysis
Time frame
Hospitalization or Day 1 (T0), to the discharge avarege Day 20 (T1).Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Joel Pollet
Lead sponsor
Fondazione Don Carlo Gnocchi Onlus
Sponsor institution
Source ClinicalTrials.gov