Knee Osteotomy Associated With Allograft Meniscus Transplantation

December 3, 2025 updated by: Istituto Ortopedico Rizzoli

Knee Osteotomy Associated With Allograft Meniscus Transplantation in Patients With Altered Mechanical Axis, Meniscectomy Outcomes, and Osteoarthritis: Clinical, Biomechanical, and Biological Evaluation

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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). Serum/plasma and urine samples will be collected before surgical treatment and at 1-3-6-12 months follow-up.

Study Type

Interventional

Enrollment (Estimated)

52

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Italy
      • Bologna, Italy, 40136
        • Recruiting
        • Istituto Ortopedico Rizzoli
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Gina Lisignoli, PhD
        • Sub-Investigator:
          • Claudio Belvedere, Eng

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Male or female patients aged between 20 and 60 years;
  2. Single-compartment tibiofemoral osteoarthritis (Kellgren-Lawrence grade ≤ 3);
  3. Surgical indication of corrective osteotomy (axial deviation of lower extremities > 5°);
  4. Meniscal deficit of the compartment affected by the overload due to malalignment;
  5. Ability and consent of patients to actively participate in the rehabilitation protocol and clinical and radiological follow-up (RX and MRI)
  6. Signature of informed consent

Exclusion Criteria:

  1. Patients who are incapacitated or have neurological disorders that may invalidate the research protocol;
  2. Diagnosis of neoplastic diseases;
  3. 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;
  4. Patients with uncontrolled diabetes mellitus;
  5. Patients with uncontrolled thyroid metabolic disorders;
  6. Patients abusing alcoholic beverages, drugs or medications;
  7. Body Mass Index > 40;
  8. Pregnancy or lactation status or intention to become pregnant during the period of study participation;
  9. Patients undergoing knee surgery in the previous 12 months.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Knee Ostetomy combined with meniscal allograft transplantation
The treatment group will perform osteotomy and meniscal allograft transplantation to restore the meniscal deficiency.
Procedure: Knee osteotomy associated with meniscal allograft transplantation
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.
Active Comparator: Knee Osteotomy
The control group will consist of patients who will perform an isolated osteotomy.
Procedure: Knee osteotomy
Knee osteotomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
IKDC-Subjective Score (Subjective International Knee Documentation Committee)
Time Frame: 12 months follow-up
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
12 months follow-up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
IKDC-Subjective Score (Subjective International Knee Documentation Committee)
Time Frame: baseline, 1 month, 3 months and 6months follow-up
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
baseline, 1 month, 3 months and 6months follow-up
WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) score
Time Frame: baseline, 1 month, 3 months, 6 months and 12 months follow-up
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.
baseline, 1 month, 3 months, 6 months and 12 months follow-up
KOOS Score ( Knee Injury and Osteoarthritis Outcome score)
Time Frame: baseline, 1 month, 3 months, 6 and 12 months follow-up
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
baseline, 1 month, 3 months, 6 and 12 months follow-up
VAS-dolore (Visual Analogue Scale)
Time Frame: baseline, 1 month, 3 months, 6 and 12 months follow-up
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."
baseline, 1 month, 3 months, 6 and 12 months follow-up
EQ-VAS
Time Frame: baseline, 1 month, 3 months, 6 and 12 months follow-up
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."
baseline, 1 month, 3 months, 6 and 12 months follow-up
Tegner Activity Level Scale
Time Frame: baseline, 1 month, 3 months, 6 and 12 months follow-up
It is a questionnaire to find out the patient's level of physical activity.
baseline, 1 month, 3 months, 6 and 12 months follow-up
Final treatment opinion
Time Frame: 6 and 12 months follow-up
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".
6 and 12 months follow-up
WORMS (Whole-Organ Magnetic Resonance Imaging Score)
Time Frame: baseline, 12 months follow-up
It's a semiquantitative, multifunctional scoring method for knee assessment applicable to conventional MRI techniques.
baseline, 12 months follow-up
Kellgren-Lawrence score
Time Frame: baseline, 1 month, 6 months, 12 months follow-up.
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
baseline, 1 month, 6 months, 12 months follow-up.
Biomechanical analysis
Time Frame: baseline, 12 months follow-up
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.
baseline, 12 months follow-up
Biological assessments
Time Frame: Baseline (pre-operative), 24 hours, 1 month, 3 months, 6 months, 12 months
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.
Baseline (pre-operative), 24 hours, 1 month, 3 months, 6 months, 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istituto Ortopedico Rizzoli

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 30, 2023

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

June 1, 2026

Study Registration Dates

First Submitted

April 19, 2023

First Submitted That Met QC Criteria

May 2, 2023

First Posted (Actual)

May 3, 2023

Study Record Updates

Last Update Posted (Estimated)

December 4, 2025

Last Update Submitted That Met QC Criteria

December 3, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BIOMAT

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

We will be able to share a subset of aggregated data, wich will not allow for the identification of participants.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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