BADAL X Surgical Technique

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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. In transfemoral amputees the knee joint space of the contra-lateral limb is used as reference to match the knee flexion axis of the external prosthesis exactly with the knee joint space of the sound limb. That means that in cases with long femur remnants the planned bone cut should be at least 150mm proximal of the ipsilateral medial knee joint line (Fig 1). 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. DCA size 70 and 80 are mostly used for transtibial amputees.

Fig 1. Presurgical planning  

Single or two stage surgery for BADAL X implantation

BADAL X is preferably implanted in a two-stage surgical procedure, 4-6 weeks apart. In exceptional cases where there is few soft tissue coverage of the residual bone, BADAL X may be installed in a single surgical procedure. Bone anchoring devices in dentistry and amputee-care are originally developed for implantation in a two stage procedure. The philosophy of surgery in two stages is based on the idea that the implant needs a period of 4 to 6 weeks to integrate with the bone preferably in a sterile environment. It is believed that this is necessary to avoid bacterial colonisation from the stoma ascending along the implant. Therfore, a tight seal of the intramedullary canal is desirable. It is suggested that this tight seal between implant and bone could be accomplished in 4 to 6 weeks. However, this assumption has never been demonstrated in clinical studies and nowadays more and more surgeons tend towards single stage surgery. Prospective clinical trials are underway to demonstrate whether safety of single stage surgery is equivalent to two stage surgery. For the time being, OTN Implants recommends the two stage surgery approach for BADAL X implantation unless this is not possible in cases with few soft tissue coverage of the bone. 

Surgery stage one for long femur

BADAL X implant OFI-C (curved) is used in cases with femur remnants longer than 140mm, measured from the mid-line of the lesser trochanter to the tip of the femur (Fig 2). In these cases the diaphyseal part of the femur makes a small curvature in the sagital plane which requires a curved implant. 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. The first stage starts with correct supine positioning of the subject and draping and prepping following local standard orthopedic protocols. A mediolateral moon- or smiley-like skin incision is performed to create a slightly longer anterior flap (Fig 3). 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. 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 (Fig 4) according to calculations in the pre-surgical plan. In cases with a narrow medullary canal, standard non-cutting flexible reamers under x-ray imaging may be used and finally, the intramedullary cavity is reamed by hammering in and out the Curved Rasps and (Fig 5). Reaming is terminated at the rasp diameter equal to the diameter of OFI-C stem selected in the pre-surgical plan. The Distal Tip Rasp is used to create a plane exactly perpendicular to the longitudinal axis of the femur (Fig 6). Four 1.25mm holes are drilled into the femur tip and preloaded with Vicryl CP-1, CT-1 absorbable sutures (Fig 7). These sutures are used for the myodesis later on. Note that the diameter of the selected OFI-C stem is equivalent with the diameter of the last used Curved Rasp to obtain optimal press-fit fixation. The OFI-C stem is placed on the Installer and press fit hammered into the femur (Fig 8). After thoroughly rinsing the wound, a myodesis is completed 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 (Fig 9). Once this is completed, the location of the future stoma is determined and subcutaneous fat overlying the distal tip of the OFI-C stem is removed. Wound closure is performed per standard technique (Fig 10) with application of a stump pressure bandage. The surgical procedure is finished with intraoperative radiographic confirmation of the position of the OFI-C stem.

Fig 2. Measuring method from lesser trochanter to femur tip

Fig 3. Moon-/Smiley like skin incision

Fig 4. Cutting femur tip with oscillating saw

Fig 5. Femur reaming with curved rasp and hammer

Fig 6. Femur tip preparated with Distal Tip Rasp 

Fig 7. Drill holes in femur tip preloaded with sutures

Fig 8. Hammering in the OFI-C stem

Fig 9. Myodesis

Fig 10. Wound closure

 

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. 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. The first stage starts with correct supine positioning of the subject and draping and prepping following local standard orthopedic protocols. 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 11). A mediolateral moon- or smiley-like skin incision is performed to create a slightly longer anterior flap (Fig 3). 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. 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 (Fig 4) according to the calculations in the pre-surgical plan. The medullary canal is carefully reamed by hand with Rigid Drills (Fig 12) under constant alternating AP and sagital Xray imaging guidance to check the correct central position of the Rigid Drill. Reaming is terminated at the Rigid Drill diameter 1mm smaller than the diameter of the OFI-Y stem that was selected in the pre-surgical planning. Use the Distal Tip Rasp to create a plane exactly perpendicular to the longitudinal axis of the femur (Fig 6). The Dummy Implant, installed on the Guiding Device, is inserted into the femur to determine the final rotation angle of the OFI-Y stem (Fig 13). 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 14). This rotation angle is marked with a 1. a mark on the femurtip using the coagulator blade or 2. by using the Aiming Device clamped on the distal femur tip (Fig 15). Four 1.25mm holes are drilled into the femur tip and preloaded with Vicryl CP-1, CT-1 absorbable sutures (Fig 7). These sutures are used for the myodesis later on. The OFI-Y stem is placed on the Guiding Device and press-fit hammered into the femur (Fig 16). During insertion check that the longitudinal mark on the OFI-Y stem exactly matches with the mark on the femurtip or Aiming Device. Place the Drill Sleeve in the Guiding Device and drill first the Guide Wire and secondly drill a hole with the Canulated Drill in the hip neck under constant alternately AP and sagital Xray imaging (Fig 17). Define the Lag Screw length with the Ruler (Fig 18) and place the appropriate Lag Screw into the hip neck (Fig 19). 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 (Fig 9). Once this is completed, the location of the future stoma is determined and subcutaneous fat overlying the head of the OFI-Y stem removed. Wound closure is performed per standard technique (Fig 10) with application of a stump pressure bandage. The surgical procedure is finished with intraoperative radiographic confirmation of the position of the OFI-Y stem.

Fig 11. Patient position for OFI-Y surgery

Fig 12. Medullary canal reamed by hand with Rigid Drills

Fig 13. Dummy Implant installed on the Guiding Device inserted in the femur

Fig 14. Proper rotation angle of the Dummy Implant relative to the central axis the hip neck

Fig 15. Marking the distal femur tip

Fig 16. OFI-Y stem is placed on the Guiding Device hammered into the femur

Fig 17. Drill Sleeve in Guiding Device with respectively Guide Wire and Canulated Drill

Fig 18. Define Lag Screw length with the Ruler

Fig 19. Lag Screw in the hip neck

 

Surgery stage one for tibia

BADAL X implant OTI is used for the tibia. 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. The first stage starts with correct supine positioning of the subject and draping and prepping following local standard orthopedic protocols. A mediolateral skin incision is performed across the tibia tip (Fig 20). If necessary, redundant skin and soft tissue is excised with a moon-/smiley like incision (Fig 3). 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 (Fig 21) according to calculations in the pre-surgical plan. Use the Rigid Drills 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 (Fig 22). Note that the diameter of the selected OTI stem is 1mm larger than the last used Rigid Drill to obtain optimal press-fit fixation. Use the Distal Tip Rasp to create a plane exactly perpendicular to the longitudinal axis of the tibia (Fig 23). A myodesis is not required for tibia BADAL X implantation. Prepare the distal intramedullary drop shape by reaming the ventral tibia tip with the Tibia Rasp (Fig 24). The OTI stem is placed on the Installer and press fit hammered into the tibia (Fig 25). Under Xray guidance, drill one or two holes in the tibia to allow insertion of the Transverse Screws (Fig 26). Use the ruler to define the appropriate length of the Transverse Screws (Fig 27). Insert one or two Transverse Screws in tibia with the Hexa 4 Screwdriver (Fig 28). After thoroughly rinsing the wound, the location of the future stoma is determined and the wound closed per standard technique (Fig 29) with application of a stump pressure bandage. The surgical procedure is finished with intraoperative radiographic confirmation of the position of the OTI stem.

Fig 20. Mediolateral skin incision across the tibia tip

Fig 21. Distal cut of tibia tip with an oscillating saw

Fig 22. Reaming of the tibia with rigid drill by hand aiming at the intercondylar eminentia

Fig 23. Preparation of the tibia tip with the Distal Tip Rasp

Fig 24. Prepare the drop shape in the distal tibia tip

Fig 25. OTI stem placed on Installer and press fit hammered into the tibia

Fig 26. Drilling holes in the tibia for Transverse Screws

Fig 27. Measuring length of the Transcerse Screws with Ruler

Fig 28. Insertion of Transverse Crews in tibia with Hexa 4 Screwdriver 

Fig 29. Wound closure

 

Surgery stage two

Second stage surgery is carried out 4-6 weeks after the first stage with similar preparations and preoperative antibiotic prophylaxis. A guide-wire is used to identify the center of the BADAL X implant (Fig 30). The Coring Device is passed over the guide-wire to cut the skin and create the stoma (Fig 31). 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 (Fig 32). 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 (Fig 33). Use the Hammer and Punch to carefully further press the DCA male taper into the female taper receiver of the implant (Fig 34). Again use Retainer and Screwdriver to re-tighten the M6 Locking Screw (Fig 33). The stoma is covered with gauzes. Therby unfold a 10x10 cm gauze, wrap it around the DCA and tie it tightly around the DCA (Fig 35). This procedure may avoid minor bleedings from the stoma.

Fig 30. Guide-wire placed in the center of the BADAL X implant

Fig 31. Skin incision with Coring Device

Fig 32. DCA protrusion of 2-3 cm for DCA length determination  

Fig 33. Fastening the M6 locking screw with Retainer and Screwdriver

Fig 34. DCA taper pressing with hammer and punch

Fig 35. Gauze tied around the DCA

 

Connector and prosthesis attachment

  • One week after stage two surgery or 3 weeks in case of single stage surgery the male part of the Heli or Luci Connector is placed on top of the distal DCA taper and secured with the M14 Abutment Screw (Fig 36). 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 (Fig 37). 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 (Fig 38). For tibial BADAL X it is also 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 (Fig 39). Rehabilitation starts immediately after fitting of the prosthesis (see rehabilitation protocols)

Fig 36. Male part  on top of DCA  and secured with the M14 Abutment Screw

Fig 37. Measuring hipflexion contracture for selection of appropriate Offset Plate

Fig 38. Installation of 7 degrees valgus between Connector and prothesis

Fig 39. Check varus/valgus alignment in frontal plane with tibia BADAL X

 

Surgical sets

OTNI 13BS Basic Set

OTNI 13TR Tibia Rasp

OTNI CR01 Curved Rasps 1

OTNI CR02 Curved Rasps 2

OTNI RR01 Rigid Drills 1

OTNI RR02 Rigid Drills 2

OTNI RR03 Rigid Drills 3

OTNI LS01 Lag Screw Set

  • Lag Screw Guiding Device
  • Lag Screw Guide Sleeve 1320-0130
  • Guide Wire Sleeve 1320-0150
  • K-Wire 3.2 x450  1210-6450S*
  • Lag Screw Step Drill  1320-0191
  • Lag Screwdriver 1320-0200