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Orthopaedic Proceedings
Vol. 102-B, Issue SUPP_6 | Pages 53 - 53
1 Jul 2020
Taylor C Waters T Ries M Datta G Davis E Nathwani D Sutton P Trahey A McNamara I
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In light of recent regulatory initiatives, medical devices now require additional clinical evidence to prove their safety and efficacy. At the same time, patients' own assessment of their devices' function and performance has gained in importance. The collection of these data allows for a more comprehensive picture of clinical outcomes and complications following total knee arthroplasty (TKA).

These trends have led researchers to search for new methods of acquiring, interpreting and disseminating patient-reported outcome measurements (PROMs). The current study assesses the feasibility of a digital platform for collecting PROMs that was recently adapted for TKA patients. It sought to determine patient engagement, survey completion rates, and satisfaction with this platform.

Eighty-two patients (mean age, 63.7 years, 59% females) scheduled for TKA were enrolled from one US and six UK sites between January 12, 2018 and April 30, 2018. Patients were supplied with a mobile application (app) that collects a variety of PROMs, including four domains based on the Patient-Reported Outcome Information System (PROMIS™): physical function, depression, pain interference and pain behavior. The platform electronically administers questionnaires using computer-adaptive tests (CATs), which reduce the burden on patients by tailoring follow-up questions to account for their previous answers. Satisfaction with the app was assessed in subset of patients who evaluated its ease-of-use (n=45), likelihood that they would recommend it to family/friends (n=35), and whether they successfully used the information it provided during their recovery (n=31). These scores were taken on a 1 to 10 (worst to best) scale.

Patients demonstrated regular engagement with the platform, with 73% using the app at least once a week. Weekly engagement remained high throughout the seven-week post-operative period (Figure 1). There was a 69% completion rate of all PROMIS™ CAT surveys during the study. The four PROMIS™ CAT domains had similar survey completion rates (Figure 2). The subset of patients queried regarding their satisfaction with the app gave it favorable mean scores for ease-of-use (8.8), likelihood to recommend to a family member or friend (8.1), and their success at using its information to improve their recovery (7.4).

Initial results support this digital platform's potential for successfully and efficiently collecting large volumes of PROMs. Patients reported high levels of engagement and satisfaction.

For any figures or tables, please contact authors directly.


Surgical site infections (SSIs) are associated with significant consequences in orthopaedic surgery, where their presence can lead to ultimate revision of the implant. Furthermore, infections and impaired wound healing can prolong length of hospital stay following orthopaedic surgery, which can place additional financial burdens on healthcare systems. The current analysis was conducted to determine whether the use of the PICO single-use negative pressure wound therapy (sNPWT) system after orthopaedic surgery reduced the incidence of SSIs and length of hospital stay compared with using conventional dressings. A systematic literature review (SLR) was performed using the PubMed, Embase and Cochrane Library databases. English-language studies comparing PICO sNPWT to conventional dressings published from 2011 to August 2018 with ≥10 patients in each treatment arm were included. Reference lists of included studies were searched for further relevant studies. Meta-analyses were performed using a fixed effect (I2 < 50%) or random effects model (I2 ≥ 50%). The SLR identified 6,197 studies, of which 5 relevant studies (607 patients) were included. The odds of an SSI were reduced by 57% (odds ratio [OR]: 0.43; 95% confidence interval [CI]: 0.21–0.86; p = 0.02) and there was consistency between studies (I2 = 0%). Three studies reported on length of hospital stay. The mean difference between patient groups indicated that PICO sNPWT was associated with a 1-day reduction in hospital stay (mean difference [MD]: −0.99; 95% CI: −1.32 to −0.65; p < 0.00001) and there was again consistency between studies (I2 = 0%). These results suggest that the use of PICO sNPWT system after closed surgical incisions can reduce the incidence of SSIs and shorten the duration of hospital stay when used in orthopaedic patient populations.


Orthopaedic Proceedings
Vol. 95-B, Issue SUPP_1 | Pages 95 - 95
1 Jan 2013
Davis E Smith G Prakash K Schubert M Wegner M Martin H
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Optimum component orientation in hip arthroplasty is vital in an effort to avoid dislocation and excessive wear. Computer navigation in hip arthroplasty surgery has the potential to improve accuracy in component placement. However, it has been slow to gain widespread acceptance. One of the major concerns surgeons have is the difficulty in registering pelvic landmarks.

We used a retrospective series of 200 pelvic CT scans to validate a new methodology to construct the anterior pelvic plane, using anatomical landmarks that are easily palpated with the patient positioned and draped in the lateral decubitus position. Analysis of the scans was also made in an effort to stimulate the inaccuracies of obtaining the anterior pelvic plane through soft tissue.

When comparing the new registration methodology to the anterior pelvic plane, the error in acetabular component inclination was 0.69° (SD 2.96) and anteversion was 1.17° (SD 3.53). This compares favourably to the error in acetabular component inclination of −0.92° (SD 0.26) and anteversion of −5.24° (SD 2.09) when the anterior pelvic plane is registered through soft tissue. The data also shows that using the new registration method in more than 99.6% of cases the acetabular placement is within the safe zone as described by Lewinnek.

This study appears to show that through the identification of anatomical constants we are able to construct the anterior pelvic plane from anatomical landmarks that are easily palpable in the lateral decubitus position during hip arthroplasty. These landmarks also appear to be more accurate in obese patients than registering the anterior pelvic plane.


Orthopaedic Proceedings
Vol. 95-B, Issue SUPP_1 | Pages 68 - 68
1 Jan 2013
Pagkalos J Davis E Gallie P Macgroarty K Waddell J Schemitsch E
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Implant alignment in knee arthroplasty has been identified as critical factor for a successful outcome. Human error during the registration process for imageless computer navigation knee arthroplasty directly affects component alignment. This cadaveric study aims to define the error in the registration of the landmarks and the resulting error in component alignment.

Five fresh frozen cadaveric limbs including the hemipelvis were used for the study. Five surgeons performed the registration process via a medial parapatellar approach five times. In order to identify the gold standard point, the soft tissues were stripped and the registration was repeated by the senior author. Errors are presented as mm or degrees from the gold standard registration.

The error range in the registration of the femoral centre in the coronal plane was 6.5mm laterally to 5.0mm medially (mean: −0.1, SD: 2.7). This resulted in a mechanical axis error of 5.2 degrees valgus to 2.9 degrees varus (mean: 0.1, SD: 1.1). In the sagittal plane this error was between −1.8 degrees (extension) and 2.7 degrees (flexion). The error in the calculation of the tibial mechanical axis ranged from −1.0 (valgus) to 2.3 (varus) degrees in the coronal plane and −3.2 degrees of extension to 1.3 degrees of flexion. Finally the error in calculating the transepicondylar axis was −11.2 to 6.3 degrees of internal rotation (mean: −3.2, SD: 3.9).

The error in the registration process of the anatomical landmarks can result in significant malalignment of the components. The error range for the mechanical axis of the femur alone can exceed the 3 degree margin that has been previously been associated with implant longevity. The technique during the registration process is of paramount importance for image free computer navigation. Future research should be directed towards simplifying this process and minimizing the effect of human error.


Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_XLIV | Pages 21 - 21
1 Oct 2012
Chaudary M Davis E
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Mal-positioning of the acetabular component is associated with increased dislocation rate, increased wear and component impingement. Navigation provides real time feedback to the surgeon and allows the accurate position of implants. Compared to conventional techniques of total hip replacement; use of the imageless navigation system has shown to improve accuracy of implant positioning.

When impacting uncemented acetabular components under navigation, there is often a deviation from the planned abduction and anteversion measurement due to deflection of the implant in the reamed cavity. Although there exists the ability to navigate the reaming of the acetabular cavity; this is not widely performed. The ability to ream the acetabular cavity in the exact orientation of the planned acetabular component may provide some theoretical advantage on the final acetabular position. The purpose of this study was to compare the effect of navigated Vs free hand acetabulum reaming on achieving the planned orientation of acetabular component.

In a retrospective study we reviewed two groups of patients who underwent computer navigated placement of the acetabular component with reference to the anterior pelvic plane. We used an imageless computer navigation system for all cases (Brainlab, Munich). All procedures were performed by single surgeon (ETD) through a standard posterior approach. The patients were divided into two groups depending on the availability of the navigated reamer. In the first group (n = 57), acetabulum reaming was done under navigation and in the second group (n = 37) a non-navigated reamer was used. The acetabular cavity was reamed “line to line” or under reamed by 1 or 2mm. Intra-operative acetabular abduction and anteversion angles were planned using navigation at the discretion of the surgeon. Results of planned acetabular abduction and anteversion angles were compared with intra-operative verification using the navigation system.

In the navigated reamer group, the mean error from the planned to verified abduction angle was 1.7 degrees (SD 2.1 degrees) and in the non-navigated reamer group the mean error was 2 degrees (SD 2.6 degrees). In the navigated reamer group, the mean error from the planned to verified anteversion angle was 0.5 degrees (SD 2.8), and in the non-navigated reamer group the mean error was 0.1 degrees (SD 1.6). There was no statistically significant difference in the mean error between the navigated and non-navigated reaming groups for abduction angle (p = 0.54) or anteversion angle (p = 0.24). There was no statistical difference between the mean acetabular component size in the navigated (mean 53mm) and non-navigated (53mm) reamer groups (p = 0.8). There was no statistical difference in the mean difference in reamer size and the acetabular component size in the navigated (0.8mm) and non-navigated reamer groups (0.8mm, p = 0.52).

This study appears to show that performing reaming of the acetabular cavity under navigation does not improve the final orientation of the acetabular component when compared to using conventional non-navigated reamers. However, this study only considered the abduction and anteversion orientation of the component. The move to a range of movement or kinematic orientation of the acetabular component in hip arthroplasty requires control over the off-set of the acetabular component which may be more easily achieved when the reaming is performed under navigation. This study used a conventional posterior approach rather than a minimal incision technique, where the use of navigated reaming may also provide some theoretical advantage when visibility is limited. Further study is required in these two areas.

There appears to be a slightly higher standard deviation for the anteversion measurement in the navigated reamer group when compared to the non navigated reamer group, although this is not significant. It is difficult to account for this as it appears to be opposite of what one would predict. One explanation for this may come in the difference in the angled geometry of the navigated reamer when compared to the straight non navigated reamer. The angled reamer can be more difficult to control forming a cavity in the correct orientation but with the possibility for the cavity to not been perfectly hemispherical.

When using navigation to insert the acetabular component in a planned abduction and anteversion position during hip arthroplasty through a standard incision, navigating the reaming of the acetabular component does not appear to provide any advantage over the use of conventional non-navigated reamers in the final acetabular orientation.


Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_XXXIX | Pages 178 - 178
1 Sep 2012
Heaver C Mart JS Nightingale P Sinha A Davis E
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Aims

Leg length inequality following total hip replacement remains common. In an effort to reduce this occurrence, surgeons undertake pre-operative templating and use various forms of intra-operative measurements, including computer navigation. This study aims to delineate which measurement technique is most appropriate for measuring leg length inequality from a pelvic radiograph.

Method

Three observers took a total of 9600 measurements from 100 pelvic radiographs. Four lines were constructed on each of the radiographs, bisecting the acetabular teardrops (Methods 1/2), ishial spines (Method 3/4), inferior sacroiliac joint (Method 5/6) and inferior obturator foramen (Method 7/8). Measurements were taken from these lines to the midpoint on the LT and to the tip of the GT.

The effect of pelvic positioning was also assessed using radiographs of a synthetic pelvis and femur using the same eight methods by a single observer (ED).

Intra-observer variability was analysed using within subject standard deviation. Inter-observer variability was analysed using the coefficient of inter-observer variability (CIV).


Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_III | Pages 5 - 5
1 Feb 2012
Davis E Lingard E Schemitsch E Waddell J
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We aimed to identify whether patients in lower socioeconomic groups had worse function prior to total knee arthroplasty and to establish whether these patients had worse post-operative outcome following total knee arthroplasty.

Data were obtained from the Kinemax outcome study, a prospective observational study of 974 patients undergoing primary total knee arthroplasty for osteoarthritis. The study was undertaken in thirteen centres, four in the United States, six in the United Kingdom, two in Australia and one in Canada. Pre-operative data were collected within six weeks of surgery and patients were followed for two years post-operatively. Pre-operative details of the patient's demographics, socioeconomic status (education and income), height, weight and co-morbid conditions were obtained. The WOMAC and SF-36 scores were also obtained. Multivariate regression was utilised to analyse the association between socioeconomic status and the patient's pre-operative scores and post-operative outcome. During the analysis, we were able to control for variables that have previously been shown to effect pre-operative scores and post-operative outcome.

Patients with a lower income had a significantly worse pre-operative WOMAC pain (p=0.021) and function score (p=0.039) than those with higher incomes. However, income did not have a significant impact on outcome except for WOMAC Pain at 12-months (p=0.014). At all the other post-operative assessment times, there was no correlation between income and WOMAC Pain and WOMAC Function. Level of education did not correlate with pre-operative scores or with outcome at any time during follow-up. This study demonstrates that across all four countries, patients with lower incomes appear to have a greater need for total knee arthroplasty. However, level of income and educational status did not appear to affect the final outcome following total knee arthroplasty. Patients with lower incomes appear able to compensate for their worse pre-operative score and obtain similar outcomes post-operatively.