Knee Osteotomy Associated With Allograft Meniscus Transplantation
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age20-60
SponsorIstituto Ortopedico Rizzoli
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Male or female patients aged between 20 and 60 years;
Single-compartment tibiofemoral osteoarthritis (Kellgren-Lawrence grade ≤ 3);
Surgical indication of corrective osteotomy (axial deviation of lower extremities > 5°);
Meniscal deficit of the compartment affected by the overload due to malalignment;
Disqualifiers
Patients who are incapacitated or have neurological disorders that may invalidate the research protocol;
Diagnosis of neoplastic diseases;
Diagnosis of rheumatoid arthritis, Reiter's syndrome, psoriatic arthritis, gout, ankylosing spondylitis or arthritis resulting from another inflammatory disease; human immunodeficiency virus (HIV) infection, viral hepatitis; chondrocalcinosis;
Patients with uncontrolled diabetes mellitus;
Trial design
Design model
Parallel
Treatments tested in this trial
Knee osteotomy associated with meniscal allograft transplantation
Procedure/SurgeryPatients 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
Procedure/SurgeryKnee osteotomy
Treatment groups
52 Participants
are divided into 2 treatment groupsGroup A: Knee Ostetomy combined with meniscal allograft transplantationExperimental treatment 1 intervention
Group B: Knee OsteotomyActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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-upSecondary outcomes
1
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-up2
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-up3
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-up4
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-upSponsors and contacts
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Source ClinicalTrials.gov