Under construction – not a live service
Sign in
Taking peopleNo phase

Knee surgery with or without a meniscus transplant for knee osteoarthritis and misaligned legs

Compares knee osteotomy with and without meniscus transplant in people with knee osteoarthritis.

Key facts

Who runs it
Istituto Ortopedico Rizzoli
Where
Italy1 site in 1 countryChoose a country to see its sites
Trial code
Registry title
Knee Osteotomy Associated With Allograft Meniscus Transplantation
Status
Recruiting
People taking part
52 people, planned
Started
30 Aug 2023
Planned end
Jun 2026
Type of study
Interventional, 2 groupsOne group gets an existing treatment, for comparison.
Treatments tested
  • Knee osteotomy associated with meniscal allograft transplantation
  • Knee osteotomy
Record updated
4 December 2025

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with knee osteoarthritis in one part of the knee, a damaged or missing meniscus, and a misaligned leg. It compares knee osteotomy alone with osteotomy plus a donor meniscus.

Age
20 to 60 years
Sex
Men and women
Disease stage
Osteoarthritis in one compartment of the knee, Kellgren-Lawrence grade ≤ 3. Leg axis deviation > 5° needing corrective osteotomy. Meniscus deficit on the overloaded side.
Earlier treatment
No knee surgery in the previous 12 months.

Main reasons for not taking part

  • Cancer, rheumatoid arthritis, gout, other inflammatory arthritis, HIV infection, viral hepatitis or chondrocalcinosis
  • Uncontrolled diabetes or uncontrolled thyroid disorders
  • Body Mass Index > 40
  • Pregnancy, breastfeeding or plans to become pregnant during the study
  • Alcohol, drug or medication abuse, or neurological disorders that affect the study

The registry criteria, word for word

Show all 15 criteriaShow less

Who can take part

  • 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
  • Ability and consent of patients to actively participate in the rehabilitation protocol and clinical and radiological follow-up (RX and MRI)
  • Signature of informed consent

Who cannot take part

  • Patients abusing alcoholic beverages, drugs or medications
  • Patients undergoing knee surgery in the previous 12 months
  • 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
  • Patients with uncontrolled thyroid metabolic disorders
  • Body Mass Index > 40
  • Pregnancy or lactation status or intention to become pregnant during the period of study participation

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 20 and 60 years old?

This trial has no sites in United States.

It has sites in one country. Choose a country to see its sites.

About the trial

What the trial wants to find out

This is a prospective randomized double-blind controlled clinical trial with parallel arms and 1:1 allocation.

Read full original descriptionShow less

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 2 groups in the trial

  • Knee Ostetomy combined with meniscal allograft transplantationTreatment being tested

    The treatment group will perform osteotomy and meniscal allograft transplantation to restore the meniscal deficiency.

    Treatment: Knee osteotomy associated with meniscal allograft transplantation

  • Knee OsteotomyExisting treatment, for comparison

    The control group will consist of patients who will perform an isolated osteotomy.

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Knee Osteotomy Associated With Allograft Meniscus Transplantation in Patients With Altered Mechanical Axis, Meniscectomy Outcomes, and Osteoarthritis: Clinical, Biomechanical, and Biological Evaluation
Plain-language title
Knee surgery with or without a meniscus transplant for knee osteoarthritis and misaligned legsGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 14 November 2026.
Fit questions
Built from NCT05840887, who can take part
Record updated
4 December 2025