GonarthrosisUKA-L2086NCT06302075
Functional Recovery After Medial Monocompartmental Knee Prosthesis: One Day Protocol Versus Fast Protocol
A study testing One Day Rehabilitation and Fast Rehabilitation in people with Gonarthrosis, run by I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio at 1 site in Italy.
Trial summary
The study is defined as prospective, randomized, interventional single-center; the general aim is to evaluate the post-operative recovery of the patient who carries out rehabilitation with the one day protocol (Group A), compared to the patient who carries out rehabilitation during the hospital stay with the fast… Read more about this study
- Who is it for?
- Ages 40 to 85 years
- Conditions the study is for
- Gonarthrosis
- What is being tested?
- One Day Rehabilitation and Fast Rehabilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteItaly
- Study dates
- 16 Nov 2021to 1 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 40 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 40<x<85 included
- Medial monocompartmental gonarthrosis grade 3-4 sec Kellgren-Lawrence
- Primary medial gonarthrosis
- Signing of the Informed Consent and consent to collaborate in all study procedures.
Who cannot join
- Cognitive decline
- Psychiatric disorders
- Neuromuscular disorders
- Age > 85 years or <40
- Lateral gonarthrosis grade 3-4 sec Kellgren-Lawrence
- Patella symptoms
Show all 9Show fewer
- Secondary medial gonarthrosis
- Minor age
- Pregnant women (self-declaration)
Trial locations and contacts
1 site in 1 country.
Elena Cittera contact
direzionescientifica iog <direzionescientifica.iog@grupposandonato.it>
Italy1 site, 1 recruiting
- Recruiting
Istituto Clinico San Siro
Milan, Italia
Elena Cittera, 0283502224, direzionescientifica.iog@grupposandonato.it
Andrea Parente, MD
About this study
Official title: Evaluation of Functional Recovery of Patients Undergoing Medial Monocompartmental Knee Prosthesis With One Day Protocol Versus Fast Protocol
The study is defined as prospective, randomized, interventional single-center; the general aim is to evaluate the post-operative recovery of the patient who carries out rehabilitation with the one day protocol (Group A), compared to the patient who carries out rehabilitation during the hospital stay with the fast protocol (group B).
Read the detailed description
The study is defined as prospective, randomized, interventional single-center; the general aim is to evaluate the post-operative recovery of the patient who carries out rehabilitation with the one day protocol (Group A), compared to the patient who carries out rehabilitation during the hospital stay with the fast protocol (group B).
The difference will be evaluated with the Knee Society Scopre (KSS) questionnaire at 1 month after the operation.
The population is made up of two groups of patients:
25 patients Group A: one day protocol; experimental group discharged home the day (24h) after the operation and carrying out rehabilitation according to the clinical standard 25 patients Group B: fast protocol; control group discharged to the rehabilitation department of the Institute 48 hours after surgery which carries out rehabilitation during the hospital stay according to the clinical standard
The subjects will undergo the following assessments:
- Pre-admission
- Knee replacement surgery
- Rehabilitation
- Questionnaires and evaluation scales at 7 and 15 days (+/- 2 days), at 1, 3, 6 months (+/- 7 days) and 12 months (+/- 1 month) after surgery. If necessary, they can be collected by telephone.
- Conditions
- Gonarthrosis
- Being tested
- One Day Rehabilitation, Fast Rehabilitation
- Keywords
- Gonarthrosis, rehabilitation
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
One Day RehabilitationOther
Patient discharged at home the day after the operation and carrying out outpatient rehabilitation according to the clinical standard
Fast RehabilitationOther
Patient discharged to the rehabilitation department of the Institute 48 hours after surgery which carries out rehabilitation during the hospital stay according to the clinical standard
| Study group | Role | What they receive |
|---|---|---|
| One Day Rehabilitation | Experimental | discharged home the day after the operation (24 hours) and carrying out outpatient rehabilitation according to the clinical standard Receives: Other: One Day Rehabilitation |
| Fast Rehabilitation | Active comparator | discharged to the rehabilitation department of the Institute 48 hours after surgery which carries out rehabilitation during the hospital stay according to the clinical standard Receives: Other: Fast Rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Knee Society Score (KSS) from 0 to 100 (whether higher scores mean a better outcome)
To evaluate the KSS at 1 month from the surgery
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2024
- Study start16 Nov 2021
- Primary completion31 Dec 2024 (estimated)
- Study completion1 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GonarthrosisStudies of the same condition, open and under way.
- More trials run by I.R.C.C.S Ospedale Galeazzi-Sant'AmbrogioThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06302075
- Sponsor's protocol ID
- UKA-L2086
- Acronym
- UKA-L2086
- Status last verified
- Mar 2024
- First submitted
- 4 Mar 2024
- Last updated
- 12 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Functional Recovery of Patients Undergoing Medial Monocompartmental Knee Prosthesis With One Day Protocol Versus Fast Protocol
- ClinicalTrials.gov ID
- NCT06302075
- Acronym / sponsor ID
- UKA-L2086 / UKA-L2086
- Conditions
- Gonarthrosis
- Keywords
- Gonarthrosis, rehabilitation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- I.R.C.C.S Ospedale Galeazzi-Sant'AmbrogioUniversity, hospital or other
- Study start
- 16 Nov 2021 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 8 Mar 2024 (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 is defined as prospective, randomized, interventional single-center; the general aim is to evaluate the post-operative recovery of the patient who carries out rehabilitation with the one day protocol (Group A), compared to the patient who carries out rehabilitation during the hospital stay with the fast protocol (group B).
Detailed description
The study is defined as prospective, randomized, interventional single-center; the general aim is to evaluate the post-operative recovery of the patient who carries out rehabilitation with the one day protocol (Group A), compared to the patient who carries out rehabilitation during the hospital stay with the fast protocol (group B).
The difference will be evaluated with the Knee Society Scopre (KSS) questionnaire at 1 month after the operation.
The population is made up of two groups of patients:
25 patients Group A: one day protocol; experimental group discharged home the day (24h) after the operation and carrying out rehabilitation according to the clinical standard 25 patients Group B: fast protocol; control group discharged to the rehabilitation department of the Institute 48 hours after surgery which carries out rehabilitation during the hospital stay according to the clinical standard
The subjects will undergo the following assessments:
- Pre-admission
- Knee replacement surgery
- Rehabilitation
- Questionnaires and evaluation scales at 7 and 15 days (+/- 2 days), at 1, 3, 6 months (+/- 7 days) and 12 months (+/- 1 month) after surgery. If necessary, they can be collected by telephone.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| One Day Rehabilitation | Experimental | Other: One Day Rehabilitationdischarged home the day after the operation (24 hours) and carrying out outpatient rehabilitation according to the clinical standard |
| Fast Rehabilitation | Active comparator | Other: Fast Rehabilitationdischarged to the rehabilitation department of the Institute 48 hours after surgery which carries out rehabilitation during the hospital stay according to the clinical standard |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 40<x<85 included
- Medial monocompartmental gonarthrosis grade 3-4 sec Kellgren-Lawrence
- Primary medial gonarthrosis
- Signing of the Informed Consent and consent to collaborate in all study procedures.
Key exclusion criteria (9 listed)
- Cognitive decline
- Psychiatric disorders
- Neuromuscular disorders
- Age > 85 years or <40
- Lateral gonarthrosis grade 3-4 sec Kellgren-Lawrence
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| One Day RehabilitationPatient discharged at home the day after the operation and carrying out outpatient rehabilitation according to the clinical standard | Other | One Day Rehabilitation |
| Fast RehabilitationPatient discharged to the rehabilitation department of the Institute 48 hours after surgery which carries out rehabilitation during the hospital stay according to the clinical standard | Other | Fast Rehabilitation |
Primary outcome
Knee Society Score (KSS) from 0 to 100 (whether higher scores mean a better outcome)
Time frame: 1 month
To evaluate the KSS at 1 month from the surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2024.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
Elena Cittera contact
direzionescientifica iog <direzionescientifica.iog@grupposandonato.it>
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing One Day Rehabilitation and Fast Rehabilitation in people with Gonarthrosis, run by I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio 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 4 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 12 Mar 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Elena Cittera (+39 0283502224, direzionescientifica iog <direzionescientifica.iog@grupposandonato.it>), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Knee Society Score (KSS) from 0 to 100 (whether higher scores mean a better outcome) (time frame: 1 month). 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 12 Mar 2024.