Clinical Trial: "One-step" Bone Marrow Mononuclear Cell Transplantation in Talar Osteochondral Lesions

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: "One-step" Bone Marrow Mononuclear Cell Transplantation in Talar Osteochondral Lesions

Brief Summary:

BACKGROUND Osteochondral lesions are defects of the cartilaginous surface and underlying subchondral bone of the talar dome.

The use of concentrated bone marrow derived cells has been gaining successful results with arthroscopic implantation, since it is possible to transplant not only mesenchymal stem cells but also accessory cells that support angiogenesis and vasculogenesis by producing several growth factors.

OBJECTIVES Objective of this project is to identify the critical points of the regenerative treatment of osteochondral lesions of the ankle, in order to develop a standard and predictable procedure able to overcome the drawbacks of the previous techniques.

METHODS Our program is to evaluate and follow 140 new patients with focal osteochondral lesion of the talus. The surgical procedure will be executed as following: the day before the surgery the platelet gel will be produced. The day of the surgery bone marrow will be aspirate from the posterior iliac crest and concentrated directly in the operating room by centrifugation, in order to obtain 6 mL of concentrate containing nucleated cells.

Then a standard ankle arthroscopy will be performed. The scaffold will be loaded with 2 ml of bone marrow concentrate and cut into an appropriate shape.

After the scaffold implantation platelet gel will be sprayed on the top of implant, in order to provide extra growth factors and to improve the stability of the implant.

All patients will be examined clinically preoperatively, at 3, 6, 12, 24 and 36 months and at maximum follow-up. Different score scales will be used to objectivate the clinical results (AOFAS, SF-36, VAS). X-rays an

Detailed Summary:

Study design The study will be an observational prospective study. 46 patients previously operated in our center by Autologous Chondrocyte Implantation (ACI) will be used as control.

Patients 140 patients with osteochondral lesions of the talar dome will be recruited for this study. All the procedures will be performed according with specific European and Italian guidelines.

The patients will be operated as inpatients in the II Clinic of Orthopaedics and Traumatology. This is an highly specialized ward for the treatment of foot and ankle diseases. During the first day of hospitalization the patients will undergo a complete blood test and standard X-rays examination, along with specialized anesthesiologist, hematological and orthopaedic examinations.

Key inclusion and exclusion criteria Patients must satisfy the following inclusion criteria: osteochondral lesions of the talar dome ICRS grade III or IV lesion, size of the lesion >1.5 cm2, age <50 years.

Key exclusion criteria will take into account the presence of arthritis, kissing lesions, ankle malalignment and ankle instability, articular infections, hematological or rheumatic disorders.

Treatment The surgical procedure will be executed as following: the day before the surgery 120 ml of venous blood will be collected for the platelet gel production performed with an automatic method by Unit 5. The day of the surgery, 60 ml of bone marrow will be aspirate from the posterior iliac crest of the patient and concentrated directly in the operating room by a specific device (kit IOR-G1, Novagenit, Mezzolombardo, TN, Italy), in order to obtain 6 mL of concentrate bone marrow (CBM) containing nucleated cells (stem cells, monoc
Sponsor: Istituto Ortopedico Rizzoli

Current Primary Outcome: American Orthopaedic Foot and Ankle Society hindfoot score [ Time Frame: 24 months after surgery ]

American Orthopaedic Foot and Ankle Society hindfoot score will be used to assess the quality of life of the patients with a minimum score of 0 and a maximum of 100.


Original Primary Outcome: Same as current

Current Secondary Outcome: T2 mapping MRI value [ Time Frame: 12 and 24 months after surgery ]

MRI will be performed with T2 mapping sequences and T2 values will be recorded as indicator of quality through water content of the regenerated tissue.


Original Secondary Outcome: Same as current

Information By: Istituto Ortopedico Rizzoli

Dates:
Date Received: November 5, 2013
Date Started: April 2013
Date Completion: April 2017
Last Updated: January 31, 2017
Last Verified: April 2016