Treatment of Bone Marrow Edema Lesions of the Knee With Percutaneous Grafting
Condition: Bone Marrow Edema
MeSH terms: Edema
Study type: Interventional

Summary: 
      Objective

        1. To evaluate the technique of percutaneous grafting with bone substitute in the knee as
           to its applicability and technical feasibility.

        2. Evaluate the results regarding functional improvement and prevention of the evolution of
           joint cartilage degeneration.

      Material and methods Twenty patients from the Knee Group clinic who meet the criteria will be
      selected.

      Magnetic resonance imaging will be analyzed on the PACS server. Through the resonance will be
      performed evaluation of the size of the bone edema in volume and its proportion in relation
      to the size of the affected condyle or tibial plateau and the cartilage of the femoro-tibial
      joint. The lesions will then be mapped in the coronal and sagittal plane.

      Radiographs will be taken in antero-posterior, profile, Rosenberg knee and lower limb views.

      Evaluation of the patients will be performed by the visual analog pain scale and by the KOOS,
      IKDC and SF-36v1 indices.

      Description of Surgical Technique After the mapping the patient will be submitted to the
      procedure. The procedure consists in the application of a bone substitute based on injectable
      calcium phosphate in the area of bone edema previously mapped with the aid of radioscopy to
      guide. After confirming the proper positioning of the guidewire, a trephine is introduced
      through which the product will be injected. GRAFTYS HBS® (Graftys, Aix en Provence, France)
      will be used.

      The procedures will be performed in a surgical center, with conventional antisepsis and
      asepsis techniques and under spinal anesthesia. The patient will be hospitalized and must be
      discharged on the first postoperative day. After the procedure the patients will be under
      partial load as tolerated for two weeks with free range of motion and will start
      physiotherapy after 2 weeks of the procedure. During hospitalization the patient will receive
      analgesia with intravenous Dipirone 1g every 6 hours associated with Tramadol 100mg
      intravenously every 8 hours if severe pain. After discharge the patient will receive
      analgesia with dipyrone 1g orally every 6 hours associated with Tramadol 100mg orally every 8
      hours if severe pain, and Tramadol used by the patient was quantified.

      Patients will then be re-evaluated at 1, 3, 12, 24 and 48 weeks with the same previous
      criteria and at 12 months new MRI with the same previous protocol will be performed.
    

Detailed description: 
      Initial assessment

      All the patients included in the study were submitted to the initial evaluation, in which the
      following exams and scales were performed:

        -  Magnetic resonance of the affected knee, according to IOTHCFMUSP standard radiology
           protocol;

        -  Panoramic radiography of lower limbs to measure limb alignment;

        -  X-ray in antero-posterior incidence with load and knee profile;

        -  Functional ranges of subjective IKDC, KOOS and SF-36v1;

        -  Analog visual pain scale.

      Radiographic evaluation and magnetic resonance imaging

      The radiographs were evaluated and classified by a specialist radiologist in musculoskeletal,
      according to the Kellgren-Lawrence classification. The radiographs were not identified as to
      the moment of accomplishment, before or after the procedure. However, in many cases it was
      possible to identify signs of the procedure in the image, making the evaluator blind.

      In the MRI images, the location of the bone edema was evaluated in relation to the affected
      bone (femur or tibia) and affected compartment (medial or lateral). The extent of edema
      divided into three levels according to the percentage of affected area of the coronal section
      of the femoral condyle or tibial plateau was also evaluated, with grade 1 being less than
      25%, grade 2 between 25% and 50%, and grade 3 greater than 75 %. In the subchondral bone was
      also recorded the presence of fracture line, cysts and impactions / collapses of the
      articular surface. In the presence of impaction this was measured in millimeters.

      Clinical and functional evaluation

      The patients were evaluated by the functional scales: KOOS and subjective IKDC. Quality of
      life was also assessed by the SF-36v1 questionnaire.

      Patient follow-up

      Patients were followed in outpatient clinics at 1, 3, 6, 12, 24 and 48 weeks after the
      surgical procedure. Functional scales were repeated in all consultations. The quality of life
      scale was repeated at 24 and 48 weeks. Radiographs and MRI were repeated after 48 weeks of
      surgery.

      Description of surgical technique

      Magnetic resonance imaging of the patients was mapped in the surgical center to define the
      area of the lesion, as well as planning of the injection site at the center of the lesion,
      trajectory and cannula entry point. The cannula trajectory was defined by prioritizing an
      appropriate angle of attack for the entry point and larger distances of intraosseous
      trajectory, in order to avoid extravasation of the bone substitute through the cannula inlet.

      The procedures were performed under spinal anesthesia, in a surgical center. The patients
      were placed in dorsal decubitus on a radiolucent table, with a cushion below the ipsilateral
      hip, for better control of the external rotation of the limb and a cushion also under the
      ipsilateral knee, aiding in the lateral incidence of fluoroscopy, avoiding the overlap of the
      knee image contralateral.

      The material for the procedure was:

        -  An 8G metal cannula with distal and lateral exit orifice at the tip

        -  Metal cannula of the cannula with introductory tip with cut

        -  Metal cannula embolus with blunt tip

        -  High Flow Disposable Three-Way Infusion Faucet

        -  Five 1mL syringes with thread at the tip

        -  One syringe to prepare the Graftys HBS® bone substitute

      According to preoperative planning, with the help of fluoroscopy in front and profile
      incidences, the cannula entry point was demarcated, with the placement of the cannula on the
      skin. Incisions of 5 mm in length were performed with a n11 scalpel blade at the point of
      entry into the skin. The cannulae were introduced, with fluoroscopy control, towards the
      center of the previously determined lesion. The progression was done manually or with the aid
      of hammer, when greater resistance was found.

      During the introduction of the cannula, oblique incidences of fluoroscopy were performed to
      avoid perforation of the opposing cortex. The introduction of the cannula was performed very
      carefully when approaching the opposite cortical, with the possibility of using the blunt tip
      for cannula, making it difficult to perforation of the cortical.

      The bone substitute was then prepared by mixing the solid content with the liquid to liquid /
      pasty state and transferred to 1 ml syringes. Transfer to smaller diameter syringes is
      important to achieve an injection flow with lower pressure application. The bone substitutes
      when subjected to higher pressures pass into a separation phase in which the liquid separates
      from the solid part, making it impossible to deliver the material in the desired area.

      The 1 ml syringes were connected to the cannulae already positioned at the site determined
      for filling. The bone substitute was injected, interleaving the passage of a metal plunger
      through the cannula, between each syringe. Through the fluoroscopy it was possible to
      visualize the distribution of the product in the bone marrow, ensuring that the application
      was according to the mapping of the lesion and controlling the presence of possible
      extravasations. The amount of product injected was defined by the control of filling the area
      of the lesion by fluoroscopy. In cases of intra-articular extravasation, the injection was
      interrupted. After the injection was completed, it was waited 5 minutes before removal of the
      cannula, to reduce the reflux of the material through the inlet.

      Post-operative care

      The patients were hospitalized until the day after the procedure. Full load was allowed as
      tolerated for two weeks, with free range of motion. During hospitalization, patients received
      analgesia with intravenous dipyrone 1g every 6 hours, associated with intravenous tramadol
      100mg every 8 hours if they presented severe pain greater than 7. After discharge, patients
      received analgesia with dipyrone 1g orally 6 in 6 hours, associated with tramadol 100mg
      orally every 8 hours, if severe pain, for a week, and the tramadol used by the patient in
      this period was quantified.

      Surgical incision stitches were removed at the first outpatient appointment 1 week after
      surgery. The patients did not undergo physiotherapy or any type of rehabilitation after the
      procedure.
    

Intervention name(s): Percutaneous introduction of cannula; Magnetic resonance imaging; Bone Grafting
Intervention type(s): Device; Diagnostic Test; Biological
Intervention description(s): An 8 gauge cannula is introduced at the site of the bone marrow lesion. The introduction of the cannula is guided by fluoroscopy.; MRI scans will be performed on a 1.5 T (Signa Excite HD, GE Healthcare, Waukesha, WI, USA) and a specific knee coil (HD TRKnee 8 Ch High Resolution Knee Array) will be used.; A bone substitute consisting of calcium phosphate will be injected through the cannula, previously inserted, filling the area of the bone marrow lesion. GRAFTYS HBS® (Graftys, Aix en Provence, France) will be used.
Other intervention name(s): Arm: Experimental: Surgery; Arm: Experimental: Surgery
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment