Tear; Knee, Cartilage, Articular
Conditions
Keywords
chondral lesions, knee
Brief summary
The purpose of this study is to assess safety and efficacy of autologous chondrocyte implantation delivered arthroscopically into chondral lesions of the knee using clinical, biochemical, and MRI outcomes.
Detailed description
Injuries to the articular cartilage of the knee are common. They produce pain and deteriotation of patients' quality of life. The management of focal chondral lesions continues to be problematic for the treating orthopaedic surgeon. Although many treatment options are currently available, none fulfill the criteria for an ideal repair solution: a hyaline repair tissue that completely fills the defect and integrates well with the surrounding normal cartilage. Autologous chondrocyte implantation is a relatively new cell-based treatment method for full-thickness cartilage injuries that in recent years has increased in popularity, with different studies showing promising results. Typically, this implantation is performed in an open-surgery fashion. In our study the implantation of in-house autologous chondrocyte culture is done arthroscopically, situation that may offer advantages in surgery associated morbidity and patient recovery.
Interventions
DEVICEArthroscopic matrix encapsulated chondrocyte implantation
Each implant of collagen scaffold contains approximately 6,000,000 autologous chondrocytes. This constructs of 10 mm diameter are implanted arthroscopically at the defect.
Sponsors
National Council of Science and Technology, Mexico
Instituto Nacional de Rehabilitacion
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
* Patients with symptomatic chondral lesions of the knee
Exclusion criteria
* Inflammatory arthritis * Septic arthritis * Total meniscectomy * Previous microfracture at chondral lesions * Paget * Ochronosis * Acromegalia
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline to different periods in T2 Mapping for cartilage lesions after treatment. | 3, 6, 9, 12, 18, 24 36 months | Special magnetic resonance imaging technique for measurement of collagen and water content, it is expressed in milliseconds. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change of baseline to different periods in Clinical evaluation | 0, 10, 30 days, 3, 6, 9, 12, 24, 36 months | Clinical assessment with validated knee scores, and adverse effects register are taken. |
Countries
Mexico
Outcome results
None listed