Fig T1: Surgery stage one for tibia
Calibrated AP X-rays and/or CAT scans and planning software (Traumacad) are used to: define the BADAL X™ implant size and to calculate the exact level of the bone cut. DCA size 70 and 80 are mostly used for transtibial amputees.
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 T2: Skin incision
A mediolateral skin incision is performed across the tibia tip. If necessary, redundant skin and soft tissue is excised with a moon-/smiley like incision.
Fig T3: Cutting tibia tip with oscillating saw
After releasing any tethering tissue, nerves are identified and, if present, any existing neuroma excised. The distal end of the tibia is cut with an oscillating saw according to calculations in the pre-surgical plan.
Fig T4: Tibia reaming with Rigid Reamers
Use the Rigid Reamers on the T- handle to carefully ream the intramedulary canal of the tibia under constant alternating AP and sagital Xray image guidance and aim the Rigid Drill at the intercondylar eminentia. Reaming is terminated at the rigis reamer diameter equal to the diameter of OTI stem selected in the pre-surgical plan. Note that the diameter of the selected OTI stem is equivalent with the diameter of the last used Rigid Reamer to obtain optimal press-fit fixation
Fig T5: Tibia tip preparation with Distal Tip Rasp
Use the Distal Tip Rasp to create a plane exactly perpendicular to the longitudinal axis of the tibia. A myodesis is not required for tibia BADAL X™ implantation.
Fig T6: Create the drop-shape
Prepare the distal intramedullary drop shape by reaming the ventral tibia tip with the Tibia Rasp.
Fig T7, T8: Insertion of OTI
The OTI stem is placed on the Installer and press fit hammered into the tibia. Under Xray guidance.
Fig T9, T10: Prepare transverse screws (free hand)
Drill one or two holes in the tibia to allow insertion of the Transverse Screws. Use the ruler to define the appropriate length of the Transverse Screws. Insert one or two Transverse Screws in tibia with the Hexa 4 Screwdriver.
OTI transverse screw Guiding
Alternatively, make use of the OTI Guiding Device to position the transverse screw holes on the pre-indicated spots. Use the ruler to define the appropriate screw length.
Fig T11 Use of OTI DGD (NOTE: Drill holes of ø4.3 mm!)
Fig T12: Skin closure
After thoroughly rinsing the wound, the location of the future stoma is determined and the wound closed per standard technique with application of a stump pressure bandage. The surgical procedure is finished with intraoperative radiographic confirmation of the position of the OTI stem.
BADAL X™ OTI 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 T13: K-wire insertion
A guide-wire is used to identify the center of the BADAL X™ implant.
Fig T14: Skin incision
The Coring Device is passed over the guide-wire to cut the skin and create the stoma.
Fig T15, T16: 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 T17: Connector placement
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.
Fig T18: Prosthetic adjust and alignments
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. It is important to pay attention to the varus/valgus alignment in the frontal plane to avoid knee pain that may arise as a result of uneven knee load
Rehabilitation starts immediately after fitting of the prosthesis (see rehabilitation protocols)