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

NCT02005861 | Completed DMC

• 2 other identifiers: 000831011.03.2013
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

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 and MRI scan will be also taken preoperatively, and MRI will be executed at 12, 24 and 36 months of follow-up. In particular, a new qualitative MRI called T2 mapping will be performed at 24 months. EXPECTED RESULTS We expect to highlight the effectiveness of the arthroscopic bone marrow derived cells (BMDCs) transplantation in a long term follow up study, with particular attention to identify the patient population that can gain the maximum benefit from this treatment, avoiding expensive and unnecessary procedures that too often are performed.

Conditions

Osteochondritis

Keywords

osteochondral lesion; talus; ankle; cartilage repair

Outcome Measures

Primary Outcomes (1)

• American Orthopaedic Foot and Ankle Society hindfoot score

  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.

  24 months after surgery

Secondary Outcomes (1)

• T2 mapping MRI value

  12 and 24 months after surgery

Study Arms (1)

bone marrow cells transplantation

EXPERIMENTAL

surgical procedure :the day before the surgery: platelet gel production. The day of the surgery: bone marrow aspiration from the posterior iliac crest of the patient and concentration. After the bone marrow harvesting, ankle arthroscopy will be performed. The lesion will be detected and cleaned. An equine collagen type 1 scaffold (IOR-G1, Novagenit, Mezzolombardo, TN, Italy) will be loaded with 2 ml of bone marrow concentrate and implanted. After that platelet gel will be loaded on the top of implant

Procedure: bone marrow cells transplantation on collagen scaffold

Interventions

bone marrow cells transplantation on collagen scaffold PROCEDURE

120 ml of venous blood will be collected for the platelet gel production. The day of the surgery, 60 ml of bone marrow will be aspirate from the posterior iliac crest and concentrated. a standard ankle arthroscopy will be performed, with the patient in the supine position. The lesion will be detected and cleaned. An equine collagen type 1 scaffold (IOR-G1, Novagenit, Mezzolombardo, TN, Italy) will be loaded with 2 ml of bone marrow concentrate and cut into an appropriate shape to fit the lesion. After the scaffold implantation 2 ml of platelet gel will be loaded on the top of implant, in order to provide growth factors and to improve the stability of the implant.

Also known as: kit IOR-G1, a collagen scaffold, Autologous platelet gel will be implanted on the scaffold

bone marrow cells transplantation

Eligibility Criteria

• Age: 13 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Clinical diagnosis of Osteochondral lesions of the talar dome
• Presence of lesion classified as ICRS grade III or IV
• size of the lesion \>1.5 cm2
• age \<50 years

You may not qualify if:

• Presence of osteoarthritis
• presence of concomitant tibial lesion
• presence of ankle malalignment
• presence of ankle instability
• presence of rheumatic diseases

Sponsors & Collaborators

• Istituto Ortopedico Rizzoli: lead

Study Sites (1)

I Clinic, Rizzoli Orthopaedic Institute

Bologna, 40136, Italy

Location

MeSH Terms

Conditions

Osteochondritis

Condition Hierarchy (Ancestors)

Bone Diseases; Musculoskeletal Diseases; Cartilage Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases

Study Officials

• Sandro Giannini, Prof

  Rizzoli Orthopaedic Institute, Bologna, Italy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 5, 2013
• First Posted: December 9, 2013
• Study Start: April 1, 2013
• Primary Completion: April 1, 2018
• Study Completion: April 1, 2018
• Last Updated: May 12, 2023

Record last verified: 2017-08

Locations

IT (1)