Functional Recovery After Medial Monocompartmental Knee Prosthesis: One Day Protocol Versus Fast Protocol
UKA-L2086
Evaluation of Functional Recovery of Patients Undergoing Medial Monocompartmental Knee Prosthesis With One Day Protocol Versus Fast Protocol
1 other identifier
interventional
50
1 country
1
Brief 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 protocol (group B).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Nov 2021
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 16, 2021
CompletedFirst Submitted
Initial submission to the registry
March 4, 2024
CompletedFirst Posted
Study publicly available on registry
March 8, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2025
CompletedMarch 12, 2024
March 1, 2024
3.1 years
March 4, 2024
March 8, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
1 month
Study Arms (2)
One Day Rehabilitation
EXPERIMENTALdischarged home the day after the operation (24 hours) and carrying out outpatient rehabilitation according to the clinical standard
Fast Rehabilitation
ACTIVE COMPARATORdischarged to the rehabilitation department of the Institute 48 hours after surgery which carries out rehabilitation during the hospital stay according to the clinical standard
Interventions
Patient discharged at home the day after the operation and carrying out outpatient rehabilitation according to the clinical standard
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
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Cognitive decline
- Psychiatric disorders
- Neuromuscular disorders
- Age \> 85 years or \<40
- Lateral gonarthrosis grade 3-4 sec Kellgren-Lawrence
- Patella symptoms
- Secondary medial gonarthrosis
- Minor age
- Pregnant women (self-declaration)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Istituto Clinico San Siro
Milan, Italia, Italy
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 4, 2024
First Posted
March 8, 2024
Study Start
November 16, 2021
Primary Completion
December 31, 2024
Study Completion
December 1, 2025
Last Updated
March 12, 2024
Record last verified: 2024-03