Bone Marrow Aspirate Concentrate (BMAC) Supplementation for Osteochondral Lesions
Condition: Osteochondral Lesions of Talus
Study type: Interventional

Summary: 
      The purpose of this study is to determine the clinical efficacy of the application of bone
      marrow aspirate concentrate (BMAC) as a supplement to microfracture in the treatment of
      osteochondral lesions of the talus (OLTs).
    

Detailed description: 
      After appropriate patient identification and consent, patients will be asked to complete a
      100 mm visual analog pain scale, a Foot and Ankle Disability Index questionnaire, a Short
      Form-36 questionnaire, and a Short Musculoskeletal Function Assessment questionnaire. They
      will then be randomized to one of two groups: (1) microfracture alone or (2) microfracture
      plus injection of autologous BMAC.

      At the time of surgery, all patients will undergo standard ankle arthroscopy with debridement
      and microfracture of the OLT. If randomized to the microfracture alone group, no further
      intervention will take place. If randomized to the microfracture + BMAC group, then, while
      the surgeon is performing the ankle arthroscopy, the surgical assistant will perform the
      iliac crest bone marrow aspiration. The ipsilateral iliac crest will undergo sterile
      preparation and draped into the surgical field. The iliac crest aspiration site will be
      injected with 2cc of 1% lidocaine for postoperative pain control. Through an approximate 4mm
      incision, approximately 2 cm posterior to the patient's ipsilateral anterior superior iliac
      spine, a Jamshidi® type trocar/cannula system will be placed through the incision and the
      medial and lateral borders of the pelvic brim will be palpated. Once centered, the needle
      will be malleted into the pelvis between the inner and outer tables to a depth of 2-3 cm. The
      sharp trocar will be switched for the blunt trocar and introduced another 2-3cm. The blunt
      trocar is used to prevent penetration of the cannula through the inner table cortex. Next,
      60cc of iliac crest bone marrow will be aspirated. The needle will be withdrawn and the
      incision is closed with one 3-0 nylon suture. The iliac crest bone marrow aspirate is then
      passed through a filter to remove any bone spicules and then centrifuged using the Harvest
      SmartPReP 2 BMAC system (http://www.harvesttech.com). This device is approved for
      intra-operative point-of-care use for concentrating iliac crest bone marrow. Its use is
      approved at Duke. The process takes approximately 15 minutes and will be occurring
      simultaneous to the ankle arthroscopy, debridement, and microfracture of the OLT.
      Concentration of 60cc of iliac crest bone marrow aspirate typically yields 6-7cc of BMAC.
      Therefore, to provide a standard amount of BMAC across all cases, 5cc of the BMAC will be
      injected into the ankle joint through the arthroscopy incision prior to closure.

      All patients will be placed in a postoperative splint and remain non-weightbearing for six
      weeks as a standard protocol for microfracture of OLTs. They will return for the first
      postoperative visit 2-3 weeks after the surgery and the sutures will be removed.

      Additional post-surgical routine follow-up occurs at 3 months, 6 months, 1 year, and 2 years.
      These standard time-points will occur for all patients enrolled in this study. At each
      time-point, patients will be asked to complete a 100 mm visual analog pain scale, a Foot and
      Ankle Disability Index questionnaire, a Short Form-36 questionnaire, and a Short
      Musculoskeletal Function Assessment questionnaire. At the one-year time-point, patients will
      be scheduled for a repeat MRI.
    

Intervention name(s): ankle arthroscopy with debridement and microfracture of the OLT; Bone Marrow Aspirate injection
Intervention type(s): Procedure; Other
Intervention description(s): ankle arthroscopy with debridement and microfracture of the OLT
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: OLT; Surgical Intervention; BMAC