An interventional study of Knee osteotomy associated with meniscal allograft transplantation and Knee osteotomy in Malalignment, Bone and Osteoarthritis, Knee, sponsored by Istituto Ortopedico Rizzoli. Recruiting at 1 site in Italy. Open to participants aged 20 Years to 60 Years. Per ClinicalTrials.gov, last updated 2025-12-04.
Sponsored by Istituto Ortopedico Rizzoli · Not applicable, Interventional, and Treatment
This is a prospective randomized double-blind controlled clinical trial with parallel arms and 1:1 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.
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). Serum/plasma and urine samples will be collected before surgical treatment and at 1-3-6-12 months follow-up.
3,302 studies on the registry are indexed under Osteoarthritis, Knee; 608 are open to participants now.
This study's planned enrollment of 52 is below the median of 70 across 2,731 interventional studies indexed under Osteoarthritis, Knee.
Browse Osteoarthritis, Knee studies →Istituto Ortopedico Rizzoli is the lead sponsor of 298 studies on the registry; 102 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
The treatment group will perform osteotomy and meniscal allograft transplantation to restore the meniscal deficiency.
Procedure: Knee osteotomy associated with meniscal allograft transplantation
The control group will consist of patients who will perform an isolated osteotomy.
Procedure: Knee osteotomy
Patients will undergo knee osteotomy associated with meniscal allograft transplantation, which will be implanted by arthroscopic technique with body fixation by all-inside and transosseous sutures to the posterior horn and if necessary to the anterior horn.
Knee osteotomy
IKDC-Subjective Score (Subjective International Knee Documentation Committee)
This is a subjective, knee-specific rating scale that is considered one of the most reliable assessment tools in the evaluation of knee pathology. The questionnaire examines 3 categories: symptoms, sports activity, and knee function
Time frame: 12 months follow-up
IKDC-Subjective Score (Subjective International Knee Documentation Committee)
This is a subjective, knee-specific rating scale that is considered one of the most reliable assessment tools in the evaluation of knee pathology. The questionnaire examines 3 categories: symptoms, sports activity, and knee function
Time frame: baseline, 1 month, 3 months and 6months follow-up
WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) score
It's a standardized and widely used questionnaire to assess the condition of patients with knee OA and includes assessment of pain, stiffness and physical function of the joints. It can be administered to the patient. It measures 5 items for pain (range 0-20), two for stiffness (range 0-8), and 17 for functional limitation (range 0-68) that mainly relate to activities of daily living (e.g., getting up from a sitting position, bending over, going up and down stairs etc.); the score is then normalized on a 0-100 scale. Higher values indicated a worse outcome.
Time frame: baseline, 1 month, 3 months, 6 months and 12 months follow-up
KOOS Score ( Knee Injury and Osteoarthritis Outcome score)
The full questionnaire consists of five subscales and they cover: pain (9 items), symptoms (7 items of which two relate to stiffness), functions and activities of daily living (17 items) physical function, sports activities and leisure (5 items) and quality of life in relation to the knee (4 items). All items in the relevant subscales have the same response mode, use a 5-point Likert scale, and each question is assigned a score from 0 to 4, where 0 indicates "no difficulty" and 4 "a severe difficulty). Score range 0-100 for each subscale
Time frame: baseline, 1 month, 3 months, 6 and 12 months follow-up
VAS-dolore (Visual Analogue Scale)
Visual analog scale consisting of a straight line segment (10 cm length), the ends of which correspond to "no pain" and "the strongest pain imaginable."
Time frame: baseline, 1 month, 3 months, 6 and 12 months follow-up
EQ-VAS
Visual analog scale consisting of a straight line segment (10 cm length), the ends of which correspond to "no pain" and "the strongest pain imaginable."
Time frame: baseline, 1 month, 3 months, 6 and 12 months follow-up
Tegner Activity Level Scale
It is a questionnaire to find out the patient's level of physical activity.
Time frame: baseline, 1 month, 3 months, 6 and 12 months follow-up
Final treatment opinion
The patient should indicate satisfaction and relative degree with treatment at the end of the clinical trial (24 months follow-up). All patients will be able to indicate their health condition by choosing from this answers; "Full recovery", "much better", "somewhat better", "no change", "a little worse", "much worse".
Time frame: 6 and 12 months follow-up
WORMS (Whole-Organ Magnetic Resonance Imaging Score)
It's a semiquantitative, multifunctional scoring method for knee assessment applicable to conventional MRI techniques.
Time frame: baseline, 12 months follow-up
Kellgren-Lawrence score
The Kellgren Lawrence scale classifies knee OA into 4 grades of subsequent greater severity, the parameters used being reduced joint space and the presence of osteophytes
Time frame: baseline, 1 month, 6 months, 12 months follow-up.
Biomechanical analysis
Collection of three-dimensional spatial motion data using a 9-camera stereophotogrammetric system combined with wireless 16-channel electromyograph and two force platforms for monitoring foot-ground reaction force. The acquired data will be used to estimate joint rotations and moments, spatiotemporal data, electromyography, and dynamometric data.
Time frame: baseline, 12 months follow-up
Biological assessments
Synovial tissue and fluid samples will be collected after intraoperative confirmation of patient inclusion criteria (complete meniscal deficit and absence of severe articular cartilage impairment). Synovial tissue will be fixed, included and analyzed by immunohistochemistry methods for synovitis analysis using a standardized synovitis analysis score (IMSYC). Synovial fluid will be divided into aliquots and stored at -80°C. Inflammatory factors will be analyzed by enzyme immunoassays. Serum/plasma and urine samples will be collected from all patients included in the study at the indicated time points.
Time frame: Baseline (pre-operative), 24 hours, 1 month, 3 months, 6 months, 12 months
Plan to share: No — We will be able to share a subset of aggregated data, wich will not allow for the identification of participants.
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Bone Malalignment
Istituto Ortopedico Rizzoli