The spine is a common site of metastasis. Complications include pathologic fracture, spinal cord compression, and neurological deficits. Vertebroplasty (VP) and Balloon Kyphoplasty (KP) are minimally invasive stabilization procedures used as a palliative treatment to improve mechanical stability, quality of life, and reduce pain. Photodynamic therapy (PDT) is a tumour-ablative modality that may complement mechanical stability afforded by VP/KP. This first-in-human study evaluates PDT safety when applied in conjunction with VP/KP.

This dose escalation trial involved one light only control group and four light-drug doses (50,100,150,200J;n=6) delivered at 150mW from a 690nm diode laser by 800-micron optical fibers prior to KP/VP. Patients eligible for VP/KP in treating pathologic fracture or at-risk lesions at a single level were recruited. Exclusion criteria included spinal canal compromise or neurologic impairment. PDT is a two-step binary therapy of systemic drug followed by intravertebral light activation. Light was applied via bone trochar prior to cementation. This study used a benzoporphyrin derivative monoacid (BPD-MA), Verteporfin (VisudyneTm), as the photosensitizer drug in the therapy. Drug/light safety, neurologic safety, generic (SF-36), and disease-specific outcomes (VAS, EORTC-QLQ-BM22, EORTC-QLQ-C15-PAL) were recorded through six weeks. Phototoxicity and the side effects of the BPD-MA were also examined following PDT use.

Thirty (10 male, 20 female) patients were treated (13 KP, 17 VP). The average age was 61 and significantly different between genders (Male 70yrs vs. Female 57yrs: p 0.05), and tumour status (lytic vs. mixed blastic/lytic: p>0.05). In most cases, fluence rates were similar throughout PDT treatment time, indicating a relatively stable treatment. Twelve (40%) of patients experienced complications during the study, none of which were attributed to PDT therapy. This included two kyphoplasty failures due to progression of disease, one case of shingles, one ankle fracture, one prominent suture, one case of constipation due to a lung lesion, one case of fatigue, and five patients experienced pain that was surgically related or preceded therapy.

Vertebral PDT appears safe from pharmaceutical and neurologic perspectives. KP/VP failure rate is broadly in line with reported values and PDT did not compromise efficacy. The 50J group demonstrated an improved response. Ongoing study determining safe dose range and subsequent efficacy studies are necessary.

The Bernese periacetabular osteotomy (PAO) described by Ganz, et al. is a commonly used surgical intervention in hip dysplasia. PAO is being performed more frequently and is a viable alternative to hip arthroplasty for younger and more physically active patients. The procedure is challenging because pelvic anatomy is prohibitive to visibility and open access and requires four X-ray guided blind cuts around the acetabulum to free it from the hemi-pelvis. The crucial step is the re-orientation of the freed acetabulum to correct the inadequate coverage of the femoral head by idealy rotating the freed acetabular fragment.

Diagnosis and the decision for surgical intervention is currently based upon patient symptoms, use of two-dimensional (2D) radiographic measurements, and the intrinsic experience of the surgeon. With the advent of new technologies allowing three-dimensional reconstructions of hip anatomy, previous two-dimensional X-ray definitions have created much debate in standardizing numerical representations of hip dysplasia. Recent work done by groups such as Arminger et al. have combined and expanded two-dimensional measurements such as Center-Edge (CE) angle of Wiberg, Vertical-Center-Anterior margin (VCA) angle, Acetabular Anteversion (AcetAV) and applied them to three-dimensional CT rendering of hip anatomy. Further, variability in pelvic tilt is a confounding factor and has further impeded measurement translatability.

Computer assisted surgery (CAS) and navigation also called image-guided surgery (IGS) has been used in clinical cases of PAO with mixed results. The first appearing study of CAS/IGS in PAO was conducted by Langlotz, et. al 1997 and reported no clinical benefit to using CAS/IGS. However, they did conclude that the use of CAS/IGS is undoubtedly useful for surgeons starting this technically demanding procedure. This is supported by a more recent study done by Hsieh, et. al 2006 who conducted a two year randomised study of CAS/IGS in PAO and concluded its feasibility to facilitate PAO, but there was not an additional benefit when conventional PAO is done by an experienced surgeon. A study done by Peters, et. Al 2006 studying the learning curve necessary to become proficient at PAO found that “The occurrence of complications demonstrates a substantial learning curve” and thus makes a compelling argument for the use of CAS/IGS.

A major obstacle to navigation and CAS/IGS revolves around consistency, intra-operative time and ease of use. Custom made guides and implants may help circumvent these limitations. The use of CAS/CAM in developing custom made guides has been proven very successful in areas of oral maxillofacial surgery, hip arthroplasty, and knee replacement surgeries. Additionally, a significant study in the development of rapid prototyping guides in the treatment of dysplastic hip joints was done by Radermacher et. al 1998. They describe a process of using CAS/CAM within the operational theatre using a desktop planning station and a manufacturing unit to develop what they termed as “templates” to carry out a triple osteotomy.

Our group is evaluating and developing strategies in PAO using CAS/IGS and more recently using CAS and computer aided modeling (CAM) to develop custom made guides for acetabular positioning. Our first study (Burch et al.) focused on CAS/IGS in PAO using cadavers and yielded small mean cut (1.97± 0.73mm) and CE angle (4.9± 6.0) errors. Our recent study used full sized high-resolution foam pelvis models (Sawbones^®, Vashon, Washington) and used CAS/IGS to carry out the pelvic cuts and CAS/CAM to develop a acetabular positioning guide (APG) by rapid prototyping. The CAS/IGS pelvic cuts results were good (mean error of 3.18 mm ± 1.35) and support our and other studies done using CAS/IGS in PAO. The APG yielded high accuracy and was analysed using four angles with an overall mean angular error of 1.81 (0.55⁰)and individual angulation was as follows: CE 0.83° ± 0.53, S-AC 0.28° ± 0.19, AcetAV 0.41° ± 0.37, and VCA 0.68° ± 0.27. To our knowledge this is the first developed APG for PAO.

The APG we developed was to demonstrate the concept of using a positioning guide to obtain accurate rotation of the acetabular fragment. For a clinical application a refined and sleeker design would be required. Further, because working space within the pelvis is extraordinary constrained, once fitted the APG would need to remain and serve as an implantable cage capable of holding bone graft. A potential material is polyetheretherketone (PEEK). Customised PEEK implants and cages have been established in the literature and is a potential option for PAO. The benefits of an implant not only serve to constrain the acetabular fragment in the ideal position based upon the pre-operative plan, but may also provide the structural support for rotations not other wise possible.

Though CAS/IGS is a proven viable option, we envision a potentially simpler method for PAO, the use of a cut guide and an acetabular positioning implant. Using customized guides and implants could potentially circumvent the need for specialised intra-operative equipment and the associated learning curves, by providing guides that incorporate the pre-operational plan within the guide, constraining the surgeon to the desired outcome.