Ignite Creation Date:
2024-05-06 @ 6:58 PM
Last Modification Date:
2024-10-26 @ 2:57 PM
Study NCT ID:
NCT05840887
Status:
RECRUITING
Last Update Posted:
2023-10-16
First Post:
2023-04-19
Brief Title:
Knee Osteotomy Associated With Allograft Meniscus Transplantation
Sponsor:
Istituto Ortopedico Rizzoli
Organization:
Istituto Ortopedico Rizzoli
Study Overview
Official Title:
Knee Osteotomy Associated With Allograft Meniscus Transplantation in Patients With Altered Mechanical Axis Meniscectomy Outcomes and Osteoarthritis Clinical Biomechanical and Biological Evaluation
Status:
RECRUITING
Status Verified Date:
2024-09
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:
This is a prospective randomized double-blind controlled clinical trial with parallel arms and 11 allocation
The main objective of the BIOMAT project is to demonstrate through an RCT whether the combined approach by knee osteotomy and MAT can provide clinical improvement over knee osteotomy alone for the treatment of patients with monocompartmental knee OA associated with meniscal insufficiency and lower extremity malalignment Secondary objectives are to demonstrate whether the addition of MAT to knee osteotomy in patients with monocompartmental OA can improve biomechanical parameters and whether this treatment has protective effects on the joint environment and cartilage degeneration
The main objective of the BIOMAT project is to demonstrate through an RCT whether the combined approach by knee osteotomy and MAT can provide clinical improvement over knee osteotomy alone for the treatment of patients with monocompartmental knee OA associated with meniscal insufficiency and lower extremity malalignment Secondary objectives are to demonstrate whether the addition of MAT to knee osteotomy in patients with monocompartmental OA can improve biomechanical parameters and whether this treatment has protective effects on the joint environment and cartilage degeneration
Detailed Description:
Patients with single-compartment arthritic pathology of the knee axial deviation and meniscal deficit for whom a surgical indication of corrective osteotomy is placed will be recruited into the study
Enrollment takes place during hospitalization and is by the physician All patients will undergo a knee osteotomy to achieve proper alignment of the lower limb and an arthroscopic procedure to macroscopically verify the status of the cartilage and menisci with associated minor procedures for surgical cleanup when necessary After intraoperative confirmation of inclusion criteria complete meniscal deficit and absence of severe articular cartilage impairment all patients will undergo synovial biopsy and synovial fluid sampling half of the patients will also undergo arthroscopic homologous meniscus transplantation
Clinical biomechanical and biological evaluations will be performed
Clinical evaluation of the patient will be done through validated questionnaires before surgery and at 1-3-6-12 months These will document subjective clinical improvement functional measurements and imaging using radiographs as per clinical practice and MRI
Pitch Analysis will be used for biomechanical assessments and will be performed before surgery and at 12-month follow-up after surgery for all patients enrolled in the two groups
basal inflammation will be assessed on synovial tissue and synovial fluid samples collected after intraoperative confirmation of patient inclusion criteria complete meniscal deficit and absence of severe articular cartilage impairment Serumplasma and urine samples will be collected before surgical treatment and at 1-3-6-12 months follow-up
Enrollment takes place during hospitalization and is by the physician All patients will undergo a knee osteotomy to achieve proper alignment of the lower limb and an arthroscopic procedure to macroscopically verify the status of the cartilage and menisci with associated minor procedures for surgical cleanup when necessary After intraoperative confirmation of inclusion criteria complete meniscal deficit and absence of severe articular cartilage impairment all patients will undergo synovial biopsy and synovial fluid sampling half of the patients will also undergo arthroscopic homologous meniscus transplantation
Clinical biomechanical and biological evaluations will be performed
Clinical evaluation of the patient will be done through validated questionnaires before surgery and at 1-3-6-12 months These will document subjective clinical improvement functional measurements and imaging using radiographs as per clinical practice and MRI
Pitch Analysis will be used for biomechanical assessments and will be performed before surgery and at 12-month follow-up after surgery for all patients enrolled in the two groups
basal inflammation will be assessed on synovial tissue and synovial fluid samples collected after intraoperative confirmation of patient inclusion criteria complete meniscal deficit and absence of severe articular cartilage impairment Serumplasma and urine samples will be collected before surgical treatment and at 1-3-6-12 months follow-up
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