Ignite Creation Date:
2024-05-06 @ 8:14 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06305858
Status:
RECRUITING
Last Update Posted:
2024-03-12
First Post:
2024-03-05
Brief Title:
Partial Versus Total Knee Replacement in Bicompartmental Gonarthrosis Medial and Patellofemoral Prospective Functional Assessment Study
Sponsor:
IRCCS Ospedale Galeazzi-SantAmbrogio
Organization:
IRCCS Ospedale Galeazzi-SantAmbrogio
Study Overview
Official Title:
Partial Versus Total Knee Replacement in Bicompartmental Gonarthrosis Medial and Patellofemoral Prospective Functional Assessment Study
Status:
RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The study is in accordance with current legislation definable as a prospective single-center interventional randomized study
The aim of the study is to evaluate the post-operative recovery of the group A patient undergoing the partial knee replacement surgical procedure compared to the group B patient undergoing the total knee replacement surgical procedure through clinicalfunctional scores
The primary outcome is evaluate the difference in score of the KSS questionnaire at 1 month after surgery completed by the patient of group A compared to the patient of group B
The population consists of 48 adult patients with gonarthrosis divided into two groups
24 patients Group A experimental group partial denture surgical procedure
24 patients Group B control group total denture surgical procedure with patellar resurfacing
The aim of the study is to evaluate the post-operative recovery of the group A patient undergoing the partial knee replacement surgical procedure compared to the group B patient undergoing the total knee replacement surgical procedure through clinicalfunctional scores
The primary outcome is evaluate the difference in score of the KSS questionnaire at 1 month after surgery completed by the patient of group A compared to the patient of group B
The population consists of 48 adult patients with gonarthrosis divided into two groups
24 patients Group A experimental group partial denture surgical procedure
24 patients Group B control group total denture surgical procedure with patellar resurfacing
Detailed Description:
The medial unicompartmental prosthesis procedure associated with patellofemoral is reserved for active patients suffering from bicompartmental gonarthrosis in which total knee replacement is to be avoided The advantage for the patient compared to total prosthesis surgery consists in the less invasive nature of the surgical gesture in the total preservation of the cruciate ligaments and the external compartment and therefore of the native joint biomechanics with the possibility of remote revision with total prosthesis from first implant
Patients keep their knee which is coated and not replaced with advantages in terms of joint feedback and functionality in daily activities and sports practices This study aims to compare two groups of patients suffering from bicompartmental gonarthrosis medial and patellofemoral gonarthrosis Group A undergoing a bicompartmental prosthesis surgical procedure Group B undergoing a total denture surgical procedure with patellar resurfacing The two groups will be evaluated with clinical and functional scores aimed at evaluating the outcome in the two surgical procedures
The number and type of exams are as follows
Randomization to Group A or Group B ad hoc
Knee replacement surgery as usual
Compilation of KSS questionnaire at 1 2 6 12 months of follow-up with clinical and functional scores as a matter of practice
Questionnaires and scales WOMAC Tegner VAS and patient satisfaction at 2 6 12 months post intervention as a matter of practice
Recording of any adverse events at 1 2 6 12 months after surgery as a matter of practice
Patients keep their knee which is coated and not replaced with advantages in terms of joint feedback and functionality in daily activities and sports practices This study aims to compare two groups of patients suffering from bicompartmental gonarthrosis medial and patellofemoral gonarthrosis Group A undergoing a bicompartmental prosthesis surgical procedure Group B undergoing a total denture surgical procedure with patellar resurfacing The two groups will be evaluated with clinical and functional scores aimed at evaluating the outcome in the two surgical procedures
The number and type of exams are as follows
Randomization to Group A or Group B ad hoc
Knee replacement surgery as usual
Compilation of KSS questionnaire at 1 2 6 12 months of follow-up with clinical and functional scores as a matter of practice
Questionnaires and scales WOMAC Tegner VAS and patient satisfaction at 2 6 12 months post intervention as a matter of practice
Recording of any adverse events at 1 2 6 12 months after surgery as a matter of practice
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None