BridgeMD
New treatment option for Malalignment, Bone
Official title Knee Osteotomy Associated With Allograft Meniscus Transplantation
ClinicalTrials.gov ID: NCT05840887
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 20 to 60
You may be able to join if
- 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)
You likely can't join if
- 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...
- Patients with uncontrolled diabetes mellitus;
- Patients with uncontrolled thyroid metabolic disorders;
- Patients abusing alcoholic beverages, drugs or medications;
See the full eligibility criteria
- 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
- 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...
- Patients with uncontrolled diabetes mellitus;
- Patients with uncontrolled thyroid metabolic disorders;
- Patients abusing alcoholic beverages, drugs or medications;
- Body Mass Index \> 40;
- Pregnancy or lactation status or intention to become pregnant during the period of study participation;
- Patients undergoing knee surgery in the previous 12 months.
The study team makes the final eligibility decision.
Where it's taking place
- Bologna, Italy
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 20 years to 60 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bologna, Italy. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.