Custom Implants in TKA Provide No Substantial Benefit in Terms of Outcome Scores, Reoperation Risk, or Mean Alignment: A Systematic Review.

BACKGROUND: Failure to accurately replicate the native anatomy and biomechanics of the knee has been suggested to contribute to dissatisfaction after TKA. Custom implants promise a personalized surgical approach, with the aim of improving patient satisfaction and pain as well as lowering revision rates. However, some published research on custom TKA implants has found no clinically important improvements in postoperative validated outcomes scores, risks of revision or reoperation, and implant alignment. In the interest of helping to settle this controversy, a systematic review seems warranted. QUESTION/PURPOSE: In this systematic review, we asked whether custom implants result in clinically important improvements over conventional off-the-shelf implants for anatomically uncomplicated primary TKA in terms of (1) validated outcomes scores, (2) the risk of revision or reoperation, and (3) implant alignment. METHODS: The US National Library of Medicine (PubMed/Medline), Embase, Web of Science, and Cochrane Database of Systematic Reviews were systematically searched to identify publications from the past 10 years relevant to this review. Publications that compared the clinical outcome measures, number of revisions and reoperations, and radiological assessment of implant alignment of custom and standard implants with validated endpoints were eligible for inclusion. In the interest of capturing as much potentially relevant information as possible, we applied no requirement for minimum follow-up duration. Clinical outcomes were assessed using patient-reported outcome (PROM) scores including the Knee Society Score (KSS), Forgotten Joint Score, and Knee Injury and Osteoarthritis Outcome Score. The risk for revision or reoperation were evaluated by the number of early and late manipulations, debridement procedures, and replacement of one or more components. Implant alignment was compared using postoperative deviation from the neutral (0°) mechanical axis of the limb and each component and the posterior tibial slope. All qualified studies were retrospective, and all compared custom implants with standard implants. Data on 1510 patients were reviewed (749 with custom implants and 761 with off-the-shelf implants). The mean follow-up time ranged from 12 to 33 months. RESULTS: There was no apparent advantage to custom implants in terms of PROM scores. Of the five studies evaluating clinical outcomes, only one reported better KSS-Function scores at 3 months; two reported no difference, and two found inferior KSS scores. In several studies, custom implants were associated with more frequent reoperations than standard implants. Although in general there were no differences between custom and standard implants in terms of mean coronal plane limb alignment, one of seven studies found that the proportion of patients whose alignment was outside ± 3° from the neutral axis in the coronal plane was lower in the custom group than in the standard group. CONCLUSION: With generally poorer outcomes scores for pain and function, generally higher risks of reoperation and reintervention, and no overall benefit to alignment, custom implants for primary TKA for the general population currently appear to be inferior to standard implants. Whether the slight reduction in the proportion of patients with alignment outliers observed in a minority of studies will result in a substantial reduction in revision risk over time must be addressed by future studies. However, until or unless such a reduction is proven, we recommend against the routine use of custom implants in practice because of increased costs and the risks associated with their novelty. LEVEL OF EVIDENCE: Level III, therapeutic study.

Advanced functional biomechanical analysis of medial rotation knee arthroplasty.

BACKGROUND: The Medacta GMK-Sphere total knee arthroplasty (TKA) is designed to mimic the movements and stabilimidty of a natural knee for optimal post-operative function and mobility. This study aimed to quantify the early functional outcome of patients with this implant. METHODS: Patients due to undergo TKA to treat end-stage osteoarthritis were recruited into this study. Functional tests of knee range of motion (ROM), strength, and gait kinematics were carried out pre-operatively and one year post-operatively at routine clinics. Motion capture technology and a force transducer were used to collect all data. Normality tests were completed on all data sets to confirm normal distribution of the data, then paired t-tests were used to statistically compare the results. The level of significance was set as α = 0.05. RESULTS: Sixty-three patients underwent pre-operative assessments; of which 30 returned one year post-operatively and consented to have follow-up testing. The operative knee was found to have poorer function than the contralateral knee pre-operatively (p < 0.05). Post-operatively, knee ROM significantly improved on the operative side to a mean of 116.1 ± 19.0. Gait kinematics also improved, especially in the frontal plane, but some abnormal traits remained in the sagittal plane. Knee strength decreased post-operatively. CONCLUSIONS: The Medacta GMK-Sphere TKA improves knee range of motion sufficiently within the first postoperative year to allow patients to carry out most activities of daily living (>110° knee flexion), but continued poor knee strength may limit their abilities to complete tasks which are more biomechanically demanding than walking.

Health costs and efficiencies of patient-specific and single-use instrumentation in total knee arthroplasty: a randomised controlled trial.

Aim: To investigate whether patient-specific instrumentation (PSI) and single-use instrumentation (SUI) improve operating room efficiency in terms of time and cost to the healthcare provider over conventional/reusable instrumentation (CVR) when performing total knee arthroplasty (TKA). Patients and methods: Patients requiring TKA were randomised into one of four surgical groups: CVR, CVS (conventional/SUI), PSR (PSI/reusable) and PSS (PSI/SUI). All surgical procedures were video recorded to determine specific surgical time intervals. Other variables reported included the number of instrument trays used, missing equipment, direct instrument costs and the weight of the instruments the staff had to handle. Oxford Knee Score (OKS), estimated blood loss and lengths of hospital stay were also recorded as markers of patient experience. Results: PSR was significantly quicker in all the recorded time intervals, used less trays, experienced less missing equipment and resulted in lower blood loss and shorter hospital stays. SUI reported significantly slower operating room times and resulted in higher blood loss, but SUI was 88% lighter and 20% cheaper on average when compared with their reusable counterparts. Despite the economic advantages of PSI and SUI, the patients who reported greatest improvements in OKS were those allocated to the CVR group, but no clinically meaningful difference in OKS was found at any time point. Conclusions: PSI and SUI for TKA have the potential of reducing operating room times over conventional, reusable sets. This reduction will benefit theatre personnel ergonomically, while presenting the healthcare provider with potential cost-saving benefits in terms of reduced sterilisation costs and surgical times.

Gait variability and motor control in patients with knee osteoarthritis as measured by the uncontrolled manifold technique.

Knee osteoarthritis (OA) causes pain, reduced muscular strength and stiffness of the affected joint. In response, the motor control mechanism is altered, potentially compromising stability during acts of daily living. Reduced walking stability can be quantified in terms of gait variability. This study therefore aimed to identify and quantify the effects of knee arthritis on gait variability. Fifty adults (25 males/25 females) with end-stage OA of the knee sufficiently symptomatic to require joint replacement, walked on a self-paced treadmill for 2min. A motion capture system was used to record 50 consecutive gait cycles from each patient. Kinematic variability of gait was analysed using the uncontrolled manifold technique (UCM). The position of the centre of mass (COM) was chosen as the task variable for the analysis. Results showed that our patient cohort were able to maintain a stable COM whilst walking, through adopting variable combinations of hip, knee and ankle kinematics. The greatest magnitudes of instability (based on the UCM ratios) occurred during initial contact and terminal stance. Active extension of the knee joint to approximately 5° is required during these gait cycle events, meaning that these gait events are highly quadriceps dependent. This study identified and quantified components of the gait cycle where patients with knee OA are most unstable. Employment of this technique could therefore allow specific personalised prescription for prehabilitation and rehabilitation.

Is the instrumented-pointer method of calibrating anatomical landmarks in 3D motion analysis reliable?

Instrumented-pointers are often used to calibrate anatomical landmarks in biomechanical analyses. However, little is known about the effect of altering the orientation of the pointer during calibration on the co-ordinates recorded. Incorrect positioning of a landmark influences the axes created, and thus the kinematic data recorded. This study aimed to investigate the reliability of the pointer method for anatomical calibration. Two points were drawn onto a fixed box to resemble knee joint epicondyles, then a custom-made pointer was used to define the positions of these landmarks in three-dimensions. Twenty different pointer-orientations were chosen, and the position of the pointer in each of these orientations was recorded 8 times. Euclidean distances between single points were calculated for both landmarks and compared statistically (α = 0.05). Average Euclidean distances between all reconstructed points were 3.2±1.4mm (range: 0.3-7.1mm) for one landmark and 3.3±1.5mm (range: 0.3-7.9mm) for the other. The x- and y-co-ordinates recorded differed statistically when the pointer was moved about the X and Y axes (anterior/posterior and superior/inferior to landmark) (p < 0.05). No statistical differences were found between co-ordinates recorded when the pointer was moved around the Z axes (p > 0.05). ICC values for all co-ordinates were excellent, highlighting the reliability of the method (ICC > 0.90). These results support this method of anatomical calibration; however, we recommend that pointers be consistently held in a neutral oriented position (where the handle is not anterior, posterior, superior or inferior to the landmark) during calibration, to reduce the likelihood of calibration errors.