Measured outcomes from knee joint arthroplasty (TKA) have primarily focused on surgeon-directed criteria, such as alignment, range of motion measured in the clinic, and implant durability, rather than on functional outcomes. There is strong evidence that subjective reporting by patients fails to capture objective real-life function.1,2 We believe that the recent emphasis on clinical outcomes desired by the patient, as well as the need to demonstrate value, requires a new approach to patient outcomes that directly monitors ambulatory activity after surgery. We have developed and tested a system that: 1) autonomously identifies patients who are not progressing well in their recovery from TKA surgery; 2) characterizes patient activity profiles; 3) automatically alerts health care providers of patients who should be seen for additional follow-up. We anticipate that such a system could decrease secondary procedures such as manipulation under anesthesia (MUA) and reduce hospital re-admission rates thereby resulting in significant cost savings to the patient, the care providers, and insurers. The components of the system include: 1) A sensor package that is mounted correctly in relation to the knee joint (Figure 1a) and is suitable for long term use; 2) An application that runs under the Android operating system to communicate with the sensor and to gather subjective information (pain, satisfaction, perceived stability etc. together with a photograph of the surgical site (Figure 1b); 3) Software to upload the data from the phone to a remote server; 4) An analysis and reporting package that generates, among other metrics, a profile describing the patient's activity throughout the day, trends in the recovery process, and alerts for abnormal findings (Figure 1c). The system was pilot tested on 12 patients (7 females) who underwent TKA. Complete days of data collection were scheduled for each patient every two weeks until 12 weeks, starting during the second week after surgery.Introduction
Methods
Excellent reconstruction of bone will be described induced by a synthetic biomaterial without a calcium phosphate mineral phase or growth factors, and with a pore size of 35 m. The material is fabricated by a process called sphere-templating and it can be made from many synthetic materials including hydrogels, silicones, polyurethanes and glasses. All pores are identical in size and interconnected. Studies from our group have shown optimal healing in soft tissue (as suggested by extensive vascularity and minimal fibrosis) for spherical pores of 30–40 m size. Sphere-templated hydrogel implants in bone were performed using the following procedure: Under appropriate anesthesia, 18–24month old NZW rabbits underwent medial parapatellar arthrotomy, with exposure of the medial femoral condyle. A 3.5 mm end-cutting drill, locked in a rigid armature, was used to create a host graft site at the center of the articular cartilage lesion, with depth of cut matched to the sphere-templated construct thickness of 2 mm. Animals were sacrificed at one day, 28 days, and 12 weeks. After sacrifice, the femora were isolated and the condyles dissected. Condyles were fixed in 4% paraformaldehyde at 4°C for 48 hrs, decalcified in Immunocal for 14 days at 4°C and paraffin embedded. Specimens were sectioned to a thickness and stained with Safranin- O/Fast Green, hematoxylin/eosin or Masson's trichrome. Prior to decalcification, selected samples were evaluated by micro-CT utilising a Skyscan 1076 microCT low dose in-vivo X-ray scanner, slice imaging and 3D image reconstruction. Both histologically, and with micro-CT imaging, excellent tissue and mineral reconstruction was observed in the sphere templated material. The contralateral control, drilled but without implant, showed essentially no reconstruction. Since the classical paradigm for bone reconstruction requires either autologous bone, cadaver bone, or calcium phosphate scaffolds with pores >150 microns, the healing observed here suggests new avenues for bone regeneration.
