Fig Y1: Pre-surgical planning
Calibrated AP X-rays and/or CAT scans and planning software (Traumacad) are used to: define the BADAL X™ implant type and size and to calculate the exact level of the bone cut. The length of the BADAL X™ DCA is estimated based on the thickness of subcutaneous fat layer in the planned stoma area. In average DCA size 90 is used for application in transfemoral amputees. DCA size 100 and 110 for more obese persons.
BADAL X™ is implanted in a one-, or two-stage surgical procedure. In cases where there is few soft tissue coverage of the residual bone, BADAL X™ may be installed in a single surgical procedure.
Surgery is performed under general or spinal anesthesia including prophylactic intravenous antibiotics e.g. vancomycin (1 g) or cephazolin (2 g) at induction of anesthesia. Surgery is performed in supine positioning of the subject and draping and prepping following local standard orthopedic protocols.
Fig Y2: Surgery stage one for short femur
BADAL X™ implant OFI-Y is used for femurs shorter than 140 mm between distal femur tip and mid-line of the lesser trochanter. For optimal primary stability, OFI -Y has an additional fixation of a gamma-type Lag Screw through the prosthesis into the femoral head.
Fig Y3: Patient positioning
The patient is supine positioned on the traction surgery table with the contralateral leg suspended in the leg rest to allow appropriate X-ray imaging of the hipneck in AP and sagital plane.
Fig Y4, Y5, Y6: Skin incision
A mediolateral moon- or smiley-like skin incision is performed to create a slightly longer anterior flap. If necessary, redundant skin and soft tissue is excised with with the aim to create a tight and trimmed soft tissue coverage of the femur tip.
Fig Y7: Cutting femur tip with oscillating saw
After releasing any tethering tissue, nerves are identified and, if present, any existing neuroma excised. The distal end of the femur is cut with an oscillating saw according to the calculations in the pre-surgical plan.
Fig Y8: Femur reaming with Rigid Reamers
The medullary canal is carefully reamed by hand with Rigid Reamers(drills) under constant alternating AP and sagital Xray imaging guidance to check the correct central position of the Rigid Reamer. Reaming is terminated at the Rigid Reamer diameter equal to the diameter of OFI-Y stem selected in the pre-surgical plan. Note that the diameter of the selected OFI-Y stem is equivalent with the diameter of the last used Rigid Reamer to obtain optimal press-fit fixation
Fig Y9: Femur tip preparation with Distal Tip Rasp
Use the Distal Tip Rasp to create a plane exactly perpendicular to the longitudinal axis of the femur.
Fig Y10: Preparation of myodesis
Four 1.25mm holes are drilled into the femur tip and preloaded with Vicryl CP-1/CT-1 absorbable sutures. These sutures are used for the myodesis later on.
Fig Y11, 12: X ray view plan
Fig Y13: Define correct implant rotation angle with Dummy Implant on Guiding Device
The Dummy Implant, installed on the Guiding Device, is inserted into the femur to determine the final rotation angle of the OFI-Y stem relative to the hip neck. With sagital Xray imaging of the hipneck the proper rotation angle of the Dummy Implant is defined in a way that the axis of the lagscrew hole exactly matches with the central longitudinal axis of the hip neck.
Fig Y14: Marking of correct rotation angle on the femur tip
The correct rotation angle is marked on the femurtip using the coagulator blade or by using the Aiming Device clamped on the distal femur tip.
Fig Y15, Y16: Insertion of OFI-Y
The OFI-Y stem is placed on the Guiding Device and press-fit hammered into the femur. During insertion check that the longitudinal mark on the OFI-Y stem exactly matches with the mark on the femurtip or Aiming Device.
Fig Y17: Drill sleeve placement and K-wire insertion
Place the Drill Sleeve in the Guiding Device and drill the Guide Wire under X ray guidance centrally in the hipneck
Fig Y18: Drill lag screw hole
Drill a hole with the Canulated Drill in the hip neck under constant alternately AP and sagital Xray imaging. Drill up to 10mm below the hip joint space.
Fig Y19, Y20: Lagscrew placement
Define the Lag Screw length with the Ruler and screw the appropriate Lag Screw into the hip neck.
Y21: Completion of myodesis
After thoroughly rinsing the wound, the myodesis is performed by suturing the fascia layers of the thigh musculature to the distal tip of the femur with the trans-osseal Vicryl CP-1/CT-1 absorbable sutures. Once this is completed, the location of the future stoma is determined and subcutaneous fat overlying the head of the OFI-Y stem removed.
Y22: Skin closure
Wound closure is performed per standard technique with application of a stump pressure bandage. The surgical procedure is finished with intraoperative radiographic confirmation of the position of the OFI-Y stem.
BADAL X™ OFI-Y STEP 2
Surgery is performed under general or spinal anesthesia including prophylactic intravenous antibiotics e.g. vancomycin (1 g) or cephazolin (2 g) at induction of anesthesia. Surgery is performed in supine positioning of the subject and draping and prepping following local standard orthopedic protocols.
Fig Y23: K-wire insertion
A guide-wire is used to identify the center of the BADAL X™ implant.
Fig Y24: Skin incision
The Coring Device is passed over the guide-wire to cut the skin and create the stoma.
Fig Y25, Y26: DCA placement
The appropriate DCA is selected based on the thickness of the soft tissue layer in the stoma area. It is recommended that 2 to 3 cm of the gold coating of the DCA protrudes through the skin. The taper side with the two protruding pins of the DCA is inserted in the BADAL X™ implant and secured with the M6 Locking Screw using the Retainer and Hexa 4 Screwdriver. Use the Hammer and Punch to carefully further press the DCA male taper into the female taper receiver of the implant. Again use Retainer and Screwdriver to re-tighten the M6 Locking Screw. The stoma is covered with gauzes. Therby unfold a 10×10 cm gauze, wrap it around the DCA and tie it tightly around the DCA. This procedure may avoid minor bleedings from the stoma.
Fig Y27, Y28: Connector placement and prosthetic alignment
One week after stage two surgery or 3 weeks in case of single stage surgery the male part of the Luci Connector is placed on top of the distal DCA taper and secured with the M14 Abutment Screw. Preferably a certified prosthetist is required to attach the prosthesis, adjust the length and align the prosthesis in the frontal and sagital planes. Components (knee/foot) from the existing socket prosthesis are used to attach to the BADAL X™. No specific prosthetic components are required to be used in combination with BADAL X™. Based on the amount of hipflexion contracture and the length of the remnant in transfemoral amputation levels, the appropriate Offset Plate is selected. The Offset Plate is supplied with the BADAL X™ Connectors and used to compensated for the hip flexion contractures. During the first years after BADAL surgery the flexion contracture of the hip often decreases which may allow a smaller offset. The rule of thumb is that a smaller offset is better, because walking with a smaller offset is more efficient (less energy consumption). In femoral BADAL X™, apply 7 degrees valgus between the connector and the prosthesis to restore the physiological leg axis alignment.
Rehabilitation starts immediately after fitting of the prosthesis (see rehabilitation protocols)