CASE STUDY: PRO-DENSE Injectable Regenerative Graft Used to Backfill a Bone Cavity Following Resection of a Giant Cell Tumor

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1 : PRO-DENSE Used to Backfill a Bone Cavity Following Resection of a Giant Cell Tumor Contributed by: Matthew J. Seidel, MD* Lauren A. Schwartz, NP Scottsdale, AZ *Dr. Seidel is a paid consultant for Wright Medical Group, N.V. Wright Medical Group, N.V. provided financial support for this case study. These results are specific to this individual only. Individual results and activity levels after surgery vary and depend on many factors including age, weight, and prior activity level. There are risks and recovery times associated with surgery, and there are certain individuals who should not undergo surgery.

2 History A 17-year-old female cross country runner presented with a 2-year history of intermittent pain and tenderness of the left distal thigh. She had no history of trauma to the area and was taking an anti-inflammatory for pain control. The patient had no significant medical history and no personal or family history of cancer. On examination, the patient showed tenderness in the distal thigh just above the joint line. The patient had full range of motion and full strength. Initial imaging studies included x-ray and MRI. The x-rays (FIGURE 1A and 1B) showed a lytic process in the distal femur. The lesion is eccentric and expansile. 1A 1B FIGURE 1A and 1B: Pre-Op AP and lateral x-rays showing a lesion in the distal femur. 1

3 History continued... MRI scan (FIGURE 2A and 2B) reveals a metaphyseal lesion with mildly aggressive features extending somewhat into the epiphysis. A biopsy was carefully planned and performed, which showed this lesion to be a giant cell tumor. 2A 2B FIGURE 2A and 2B: Pre-Op MRI. 2

4 Overview of Giant Cell Tumor 1 Presentation Dull, aching pain that gradually increases over time. Soft tissue fullness, with swelling of the adjacent joint and possible soft tissue mass. Patient may present with a painful limp associated with weight bearing activities. Approximately 10% of patients present with a pathologic fracture. Most common location is around the knee. Slightly higher female-to-male ratio. Peak incidence of occurrence is between the third and fourth decade. Can metastasize to the lungs in 4% of cases, however these metastases are thought to be benign. Diagnosis on Imaging and Pathology Radiographs will show a lesion that is located in the metaphysis/epiphysis with eccentric geographic borders, most commonly without sclerosis. There can be cortical erosion and periosteal elevation with expansion of the cortex. Resected specimens demonstrate classic multinucleated giant cells. The osteoclasts are often distributed evenly throughout a vascular stroma of mononuclear cells that resembles histiocytes. The nuclei of the giant cell, when compared to the stromal cells, are very similar in size and appearance. They are round, ovid and even polygonal forms. Mitotic activity can be plentiful with a scarce osteoid production. Correlation of radiographic and clinical information is required due to extensive differential diagnoses consisting of malignant and benign bone tumors. Treatment Curettage with adjuvant treatment such as argon beam, phenol or liquid nitrogen is typically performed. The defect is filled with either bone graft or bone cement. Internal fixation is frequently used to add strength to the reconstruction. Recurrence Rate of recurrence is roughly 4%-30%. Highest risk of recurrence is in the first 24 months after surgical treatment. Usually detected on plain radiograph imaging with associated soft tissue swelling and pain. 1 Biermann JS, editor, Othopaedic Knowledge Update: Musculoskeletal Tumors, American Academy of Orthopaedic Surgeons,

5 Surgical Treatment The left leg was sterile prepped and draped, and a surgical tourniquet was placed. A medial incision was used followed by a subvastus dissection down to the bone. A cortical window was made in the bone, and the tumor was resected using curettes. The interior of the resulting cavity was treated with argon beam cautery, high-speed burring, and pulse irrigation. Because of the size of the lesion and concern for pathologic fracture, a side plate was placed. Injectable Regenerative Graft was then injected around the plate and into the cavity using fluoroscopic guidance (FIGURES 3A and 3B). Immediately postoperative, the patient was instructed to be non-weightbearing, 1 but was allowed passive range of motion. ** 3A FIGURE 3A and 3B: AP and lateral postoperative x-rays showing the resected cavity back-filled with. 1 The cured paste acts only as a temporary support media and is not intended to provide structural support during the healing process. **Postoperative care is the responsibility of the medical professional. 4

6 Postoperative Follow-up X-rays taken at 6 weeks (FIGURES 4A and 4B) and 3 months (FIGURES 5A and 5B) postoperatively showed minimal graft resorption and no new bone formation. It should be noted that this is typical when a resulting cavity has been treated with an adjuvant therapy such argon beam cautery, and was not cause for concern. However, because of this lack of bony ingrowth, the patient was instructed to remain non-weightbearing at the 3-month follow-up visit. ** We continued to follow the patient at 1 month intervals. 4A 4B FIGURE 4A and 4B: 6-week AP and lateral postoperative x-rays. 5A 5B FIGURE 5A and 5B: 3-month AP and lateral postoperative x-rays. Little change is noted in resorption of or bony ingrowth. This is typical following argon beam cautery. **Postoperative care is the responsibility of the medical professional. 5

7 8-Month Postoperative Follow-Up At the 8-month follow-up (FIGURES 6A and 6B), new bone formation could be seen at the periphery of the graft bolus. At this point, the patient was given clearance for weightbearing as tolerated, but was instructed to avoid running and sports. ** 3-Year Postoperative Follow-up At the 3-year follow-up, x-rays show that the bone graft material was completely resorbed and replaced by new bone growth (FIGURES 7A and 7B). There is no sign of tumor recurrence. The patient is a fully active young woman who continues to be an avid runner and participates in other sports. 6A 6B FIGURE 6A and 6B: 8-month follow-up AP and lateral x-rays. New bone formation is begun to be seen at the periphery of the bolus. 7A 7B FIGURE 7A and 7B: 3-year follow-up AP and lateral x-rays. New bone formation is begun to be seen at the periphery of the bolus. **Postoperative care is the responsibility of the medical professional. 6

8 Surgeon s Notes The giant cell tumor cavity was vigorously treated with argon beam cautery, which impacted the biologic health of the surrounding bone and prolonged the amount of time before bone graft absorption and new bone formation could be observed. The patient was made aware of this prolonged process and was counseled on restricting her activity level during the healing process. Utilization of internal fixation was helpful to maintain strength of the bone during the healing process. The fixation was placed prior to injection of the Graft. 7

9 Indications resultant paste is intended for use as a bone graft substitute to be injected or digitally packed into open bone voids/gaps that are not intrinsic to the stability of bony structure of the skeletal system (i.e., the extremities and pelvis) to cure in situ. These open bone voids may be the result of benign bone cysts and tumors (in adults and pediatric patients 6 years old), surgically created osseous defects or osseous defects created from traumatic injury to the bone. The paste provides a bone graft substitute that resorbs and is replaced with bone during the healing process. The paste cured in situ provides an open void/ gap filler that can augment provisional hardware (e.g. K-Wires) to help support bone fragments during the surgical procedure. The cured paste acts only as a temporary support media and is not intended to provide structural support during the healing process. is provided sterile for single use only. Contraindications The Bone Graft Substitute injectable paste is contraindicated where the device is intended as structural support in load-bearing bone and in articulating surfaces. Conditions representing relative contraindications include: Severe vascular or neurological disease Uncontrolled diabetes Severe degenerative bone disease Closed bone void/gap filler Pregnancy Uncooperative patients who will not or cannot follow postoperative instructions,including individuals who abuse drugs and/or alcohol Hypercalcemia Renal compromised patients Patients with a history of or active Pott s disease 8

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