We report the kinematic and early clinical results of a patient- and observer-blinded randomised controlled trial in which CT scans were used to compare potential impingement-free range of movement (ROM) and acetabular component cover between patients treated with either the navigated 'femur-first' total hip arthroplasty (THA) method (n = 66; male/female 29/37, mean age 62.5 years; 50 to 74) or conventional THA (n = 69; male/female 35/34, mean age 62.9 years; 50 to 75). The Hip Osteoarthritis Outcome Score, the Harris hip score, the Euro-Qol-5D and the Mancuso THA patient expectations score were assessed at six weeks, six months and one year after surgery. A total of 48 of the patients (84%) in the navigated 'femur-first' group and 43 (65%) in the conventional group reached all the desirable potential ROM boundaries without prosthetic impingement for activities of daily living (ADL) in flexion, extension, abduction, adduction and rotation (p = 0.016). Acetabular component cover and surface contact with the host bone were > 87% in both groups. There was a significant difference between the navigated and the conventional groups' Harris hip scores six weeks after surgery (p = 0.010). There were no significant differences with respect to any clinical outcome at six months and one year of follow-up. The navigated 'femur-first' technique improves the potential ROM for ADL without prosthetic impingement, although there was no observed clinical difference between the two treatment groups.
In a prospective and randomised clinical study, we implanted acetabular cups either by means of an imagefree computer-navigation system (navigated group, n=32) or by free-hand technique (freehand group n=32, two dropouts). Total hip replacement was conducted in the lateral position and through a minimally invasive anterior approach (MicroHip). The position of the component was determined postoperatively on CT scans of the pelvis using CT-planning software. We found an average inclination of 42.3°(range 32.7-50.6°; SD±3.8°) and an average anteversion of 24.5°(range 12.0-33.3°; SD±6.0°) in the computer-assisted study group and an average inclination of 37.9°(range 25.6-50.2°; SD±6.3°) and an average anteversion of 23.8°(range 5.6-46.9°; SD±10.1°) in the freehand group. The higher precision of computer navigation was indicated by the lower standard deviations. For both measurements we found a significant heterogeneity of variances (p<0.05, Levene's test). The mean difference between the cup inclination/anteversion values displayed by computer navigation and the true cup position (CT control) was 0.37°(SD 3.26) and −5.61°(SD 6.48), respectively. We found a bias (underestimation) with regard to anteversion determined by the imageless computer navigation system. A bias for inclination was not found. Registration of the landmarks of the anterior pelvic plane in lateral position with undraped percutaneous methods leads to an error in cup anteversion, but not to an error in cup inclination. The bias we found is consistent with a correct registration of the anterosuperior iliac spine (ASIS) and with a registration of the symphysis 1 cm above the bone, corresponding to the less compressible overlying soft tissue in this region. There was no significant correlation between the bias and the thickness of soft tissue above the pubic tubercles. We suggest use of a percutaneous registration of ASIS and an invasive registration above the pubic tubercles when computer-assisted navigation is performed in minimally invasive THR in a lateral position.
Consistent with recent meta-analysis we found reduced blood loss, similar clinical/radiographic outcome and similar complication rates compared to standard THA. Our study shows, that MI THR is a safe procedure during the learning curve of an experienced surgeon.
BackgroundImpingement can be a serious complication after total hip arthroplasty (THA), and is one of the major causes of postoperative pain, dislocation, aseptic loosening, and implant breakage. Minimally invasive THA and computer-navigated surgery were introduced several years ago. We have developed a novel, computer-assisted operation method for THA following the concept of "femur first"/"combined anteversion", which incorporates various aspects of performing a functional optimization of the cup position, and comprehensively addresses range of motion (ROM) as well as cup containment and alignment parameters. Hence, the purpose of this study is to assess whether the artificial joint's ROM can be improved by this computer-assisted operation method. Second, the clinical and radiological outcome will be evaluated.Methods/DesignA registered patient- and observer-blinded randomized controlled trial will be conducted. Patients between the ages of 50 and 75 admitted for primary unilateral THA will be included. Patients will be randomly allocated to either receive minimally invasive computer-navigated "femur first" THA or the conventional minimally invasive THA procedure. Self-reported functional status and health-related quality of life (questionnaires) will be assessed both preoperatively and postoperatively. Perioperative complications will be registered. Radiographic evaluation will take place up to 6 weeks postoperatively with a computed tomography (CT) scan. Component position will be evaluated by an independent external institute on a 3D reconstruction of the femur/pelvis using image-processing software. Postoperative ROM will be calculated by an algorithm which automatically determines bony and prosthetic impingements.DiscussionIn the past, computer navigation has improved the accuracy of component positioning. So far, there are only few objective data quantifying the risks and benefits of computer navigated THA. Therefore, this study has been designed to compare minimally invasive computer-navigated "femur first" THA with a conventional technique for minimally invasive THA. The results of this trial will be presented as soon as they become available.Trial registration numberDRKS00000739
Intraoperative fluoroscopy and imageless navigation seem equivalent in accuracy and precision to reconstruct leg length and global and femoral offset during MIS THA with the patient in the lateral decubitus position.
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