Appendix 1. Study Characteristics
Blakeney et al. [5] / 66 / RCT / Patients undergoing TKA to treat knee osteoarthritis and varus deformity. Exclusion criteria: valgus deformity or tibial deformity from previous fracture and/or osteotomy. / BrainLab Knee essential software (BrainLab, Feldkirchen, Germany) for the Genesis-II system / Femoral rotation and tibiofemoral mismatch / Femoral rotation / All surgeries were performed by one experienced knee arthroplasty surgeon who was familiar with all techniques.
Carter et al. [8] / 200 / CCT / Intervention group consisted of all primary TKAs from the fall of 2003 until 100 TKAs were included. Conventional patients were recruited in reverse sequence from the date of navigation adoption. / Stryker Knee Navigation system (Stryker Instruments, Kalamazoo, MI, USA) / Femoral and tibial rotation (according to the protocol of Berger et al. [3]) / Femoral and tibial rotation (according to the protocol of Berger et al. [3]) / Surgeries were performed by three surgeons. On the evening before the first 4 navigated surgeries, the three surgeons and surgical personnel went through a sawbones demonstration as the only special training before start of this study.
Chauhan et al. [9] / 12 / Cadaveric study / Cadaveric study performed on six cadavers that were treated with “soft-fix” fixative. / Stryker Knee Navigation system (Stryker Instruments, Kalamazoo, MI, USA) / Not reported / Femoral rotation and tibiofemoral mismatch / Two surgeons performed the surgeries. Both had some experience in conventional TKA but were relatively new to CAS.
Chauhan et al. [10] / 75 / RCT / Patients awaiting TKA. Matched for age, height, weight, BMI, ASA grade, and preoperative deformity of the limb. Exclusion criteria: active infection, malignancy. / Stryker Knee Navigation system (Stryker Instruments, Kalamazoo, MI, USA) / Not reported / Femoral and tibial rotation (according to the Perth CT protocol as described by Chauhan et al. [9]) and tibiofemoral mismatch / All surgeries were performed by one surgeon who had performed more than 250 conventional TKAs and 12 CAS TKAs before this trial.
Choong et al. [13] / 104 / RCT / Patients scheduled for primary TKA between June 2005 and July 2006. / Ci System, DePuy (DePuy Orthopaedics, Inc., Warsaw, IN, USA) / Femoral rotation / - / All surgeries were performed by 3 senior arthroplasty surgeons who had a minimum of 18’ months experience each with conventional and CAS TKAs before commencement of this trial. All surgeons attended a 2-day learning center focusing on the instruments, software, and technique of CAS before using the CAS systems in the institution.
Han et al. [17] / 55 / RCT / Patients undergoing primary TKA between July and December 2005 for treatment of knee osteoarthritis. Exclusion criteria: history of tibial or femoral fractures or pyogenic arthritis of knees in a growth period. / OrthoPilot navigation system (B. Braun Aesculap, Tuttlingen, Germany) / Femoral rotation / Femoral rotation / All surgeries were performed by one surgeon.
Hiscox et al. [22] / 32 / RCT / Patients older than 18 years undergoing primary TKA between May 2004 andJuly 2005 for treatment of knee arthritis. Subgroup analysis of first 15 patients of each arm. Exclusion criteria: deformity of the femur preventing use of an intramedullary guide and deformity or instability that necessitated use of knee implants with intramedullary stems. / Stryker Knee Navigation system (Stryker Instruments, Kalamazoo, MI, USA) / Femoral and tibial rotation (according to the protocol of Berger et al. [3]) and tibiofemoral mismatch / - / The study was completed at an academic arthroplasty center by three fellowship-trained arthroplasty surgeons who each performed greater than 100 TKAs per year. Each surgeon had performed between 5 and 20 CAS TKAs before study initiation.
Kim et al. [27] / 320 / RCT / Patients with osteoarthritis undergoing primary bilateral TKAs between January 2003 and March 2004. One knee was replaced using CAS and the other conventionally. / Vector Vision CT-free knee (BrainLab,Munich, Germany) / Femoral and tibial rotation (as described by Matziolis et al.[33]) / Femoral and tibial rotation (as described by Matziolis et al.[33]) / All surgeries were performed by one surgeon.
Kim et al. [28] / 200 / RCT / Patients undergoing bilateral primary TKAs for osteoarthritis. One knee was replaced using CAS and the other conventionally. Exclusion criteria: varus deformity greater than 20° or valgus deformity greater than 30°. / Vector Vision CT-free knee (BrainLab, Munich, Germany) / Femoral and tibial rotation (tibial component relative to the posterior margin of proximal tibia) / Femoral and tibial rotation (tibial component relative to the posterior margin of proximal tibia) / All surgeries were performed by one surgeon.
Lützner et al. [31] / 80 / RCT / The patients included had primary or secondary osteoarthritis of the knee, no previous hemi- or total arthroplasty, a mechanical axis between 20° varus and 5° valgus, and no severe instability that could not be treated with an unconstrained, cruciate-retaining prosthesis. / Stryker Navigation System, Knee Navigation Software V3.1 (Stryker Instruments, Kalamazoo, MI, USA) / Femoral and tibial rotation (as described by Matziolis et al.[33]) / Femoral and tibial rotation (as described by Matziolis et al.[33]) / All the patients were operated on by two surgeons trained in navigated TKA.
Matos et al. [32] / 42 / RCT / Patients older than 55 years with advanced degenerative knee disease, Ahlbäck 4 or 5, without previous TKA. Exclusion criteria: severe instability of knee with indication of constrained prosthesis. / TKA 4.0 software of the Orthopilot navigation system (Aesculap Orthopaedics, Tuttlingen, Germany) / Not reported / Femoral rotation / All surgeries were performed by the same surgeon, a specialist in knee replacements and experienced in the navigated technique.
Matziolis et al. [33] / 60 / RCT / Patients with presence of primary arthritis of the knee. Exclusion criteria: patients who had previous surgery on the joint or who could not be treated with an unconstrained TKA with a short stem. / PiGalileo System (Plus Orthopedics AG, Rotkreuz, Switzerland) / Femoral and tibial rotation (as described by Matziolis et al.[33]) / Femoral rotation (as described by Matziolis et al.[33]) / -
Mombert et al. [35] / 42 / RCT / Primary TKA. / Vector Vision TKR Navigation system (BrainLab AG, Heimstetten, Germany) / Femoral rotation / - / -
Schmitt et al. [41] / 47 / RCT / Patients older than 50 years with primary gonarthrosis and willing and able to give informed consent. Exclusion criteria: patients with rheumatoid arthritis, history of local infections, and gonarthrosis secondary to trauma. / KneeTrac (Stryker Howmedica Osteonics, Mahwah, NJ, USA) / Tibial rotation (tibial component relative to the ankle) / Tibial rotation (tibial component relative to the ankle) / All surgeries were performed by two surgeons.
Stöckl et al. [44] / 64 / RCT / Patients older than 18 years with osteoarthritis, avascular necrosis, or not severe posttraumatic arthritis requiring primary TKA. No previous osteosynthesis of the knee during last 12 months. Exclusion criteria: active infection, malignancy, neurologic deficit, concurrent illnesses that are likely to affect their outcome. / Stryker Knee Navigation System (Stryker Leibinger, Software Vs 1.01) (Stryker Instruments, Kalamazoo, MI, USA) / Femoral rotation and tibiofemoral mismatch / - / Six surgeons participated in the study.
Zhang et al. [47] / 64 / RCT / Bilateral TKAs between March 2007 and June 2008 with one knee treated with conventional TKA and the other with CASTKA and both knees suitable for placement of a posterior cruciate-retaining prosthesis. All had bilateral osteoarthritis. / Vector Vision CT-free navigation system (BrainLab, Feldkirchen, Germany) / Femoral rotation / - / -
Zhang et al. [48] / 81 / RCT / Patients with osteoarthritis treated with primary TKA between January 2006 and March 2007. Exclusion criteria: prior deformity correction/osteotomy, greater than 15° varus/valgus deformity, severe osteoporosis, local or systemic signs of acute infection, patients with malignancy. / Stryker Knee Navigation System (Stryker-Navigation, Kalamazoo, MI, USA) / Femoral and tibial rotation (according to the protocol of Berger et al. [3]) and tibiofemoral mismatch / Femoral and tibial rotation (according to the protocol of Berger et al. [3]) / All surgeries were performed by one surgeon.
Appendix 1. Study characteristics
RCT = randomized controlled trial; CCT = controlled clinical trial; ASA = American Society of Anesthesiologists; CAS = computer-aided surgery.