Advertisement for orthosearch.org.uk
Results 1 - 20 of 31
Results per page:
The Bone & Joint Journal
Vol. 98-B, Issue 1_Supple_A | Pages 78 - 80
1 Jan 2016
Lee G

Patient specific instrumentation (PSI) uses advanced imaging of the knee (CT or MRI) to generate individualised cutting blocks aimed to make the procedure of total knee arthroplasty (TKA) more accurate and efficient. However, in this era of healthcare cost consciousness, the value of new technologies needs to be critically evaluated. There have been several comparative studies looking at PSI versus standard instrumentation. Most compare PSI with conventional instrumentation in terms of alignment in the coronal plane, operative time and surgical efficiency, cost effectiveness and short-term outcomes. Several systematic reviews and meta-analyses have also been published. PSI has not been shown to be superior compared with conventional instrumentation in its ability to restore traditional mechanical alignment in primary TKA. Most studies show comparative efficacy and no decrease in the number of outliers in either group. In terms of operative time and efficiency, PSI tended towards decreasing operative time, saving a mean of five minutes per patient (0 to 20). Furthermore, while some cost savings could be realised with less operative time and reduced instrumentation per patient, these savings were overcome by the cost of the CT/MRI and the cutting blocks. Finally, there was no evidence that PSI positively affected clinical outcomes at two days, two months, or two years. Consequently, current evidence does not support routine use of PSI in routine primary TKA. Cite this article: Bone Joint J 2016;98-B(1 Suppl A):78–80


The Bone & Joint Journal
Vol. 103-B, Issue 3 | Pages 507 - 514
1 Mar 2021
Chang JS Kayani B Wallace C Haddad FS

Aims. Total knee arthroplasty (TKA) using functional alignment aims to implant the components with minimal compromise of the soft-tissue envelope by restoring the plane and obliquity of the non-arthritic joint. The objective of this study was to determine the effect of TKA with functional alignment on mediolateral soft-tissue balance as assessed using intraoperative sensor-guided technology. Methods. This prospective study included 30 consecutive patients undergoing robotic-assisted TKA using the Stryker PS Triathlon implant with functional alignment. Intraoperative soft-tissue balance was assessed using sensor-guided technology after definitive component implantation; soft-tissue balance was defined as intercompartmental pressure difference (ICPD) of < 15 psi. Medial and lateral compartment pressures were recorded at 10°, 45°, and 90° of knee flexion. This study included 18 females (60%) and 12 males (40%) with a mean age of 65.2 years (SD 9.3). Mean preoperative hip-knee-ankle deformity was 6.3° varus (SD 2.7°). Results. TKA with functional alignment achieved balanced medial and lateral compartment pressures at 10° (25.0 psi (SD 6.1) vs 23.1 psi (SD 6.7), respectively; p = 0.140), 45° (21.4 psi (SD 5.9) vs 20.6 psi (SD 5.9), respectively; p = 0.510), and 90° (21.2 psi (SD 7.1) vs 21.6 psi (SD 9.0), respectively; p = 0.800) of knee flexion. Mean ICPD was 6.1 psi (SD 4.5; 0 to 14) at 10°, 5.4 psi (SD 3.9; 0 to 12) at 45°, and 4.9 psi (SD 4.45; 0 to 15) at 90° of knee flexion. Mean postoperative limb alignment was 2.2° varus (SD 1.0°). Conclusion. TKA using the functional alignment achieves balanced mediolateral soft-tissue tension through the arc of knee flexion as assessed using intraoperative pressure-sensor technology. Further clinical trials are required to determine if TKA with functional alignment translates to improvements in patient satisfaction and outcomes compared to conventional alignment techniques. Cite this article: Bone Joint J 2021;103-B(3):507–514


The Bone & Joint Journal
Vol. 102-B, Issue 1 | Pages 117 - 124
1 Jan 2020
MacDessi SJ Griffiths-Jones W Chen DB Griffiths-Jones S Wood JA Diwan AD Harris IA

Aims. It is unknown whether kinematic alignment (KA) objectively improves knee balance in total knee arthroplasty (TKA), despite this being the biomechanical rationale for its use. This study aimed to determine whether restoring the constitutional alignment using a restrictive KA protocol resulted in better quantitative knee balance than mechanical alignment (MA). Methods. We conducted a randomized superiority trial comparing patients undergoing TKA assigned to KA within a restrictive safe zone or MA. Optimal knee balance was defined as an intercompartmental pressure difference (ICPD) of 15 psi or less using a pressure sensor. The primary endpoint was the mean intraoperative ICPD at 10° of flexion prior to knee balancing. Secondary outcomes included balance at 45° and 90°, requirements for balancing procedures, and presence of tibiofemoral lift-off. Results. A total of 63 patients (70 knees) were randomized to KA and 62 patients (68 knees) to MA. Mean ICPD at 10° flexion in the KA group was 11.7 psi (SD 13.1) compared with 32.0 psi in the MA group (SD 28.9), with a mean difference in ICPD between KA and MA of 20.3 psi (p < 0.001). Mean ICPD in the KA group was significantly lower than in the MA group at 45° and 90°, respectively (25.2 psi MA vs 14.8 psi KA, p = 0.004; 19.1 psi MA vs 11.7 psi KA, p < 0.002, respectively). Overall, participants in the KA group were more likely to achieve optimal knee balance (80% vs 35%; p < 0.001). Bone recuts to achieve knee balance were more likely to be required in the MA group (49% vs 9%; p < 0.001). More participants in the MA group had tibiofemoral lift-off (43% vs 13%; p < 0.001). Conclusion. This study provides persuasive evidence that restoring the constitutional alignment with KA in TKA results in a statistically significant improvement in quantitative knee balance, and further supports this technique as a viable alternative to MA. Cite this article: Bone Joint J. 2020;102-B(1):117–124


The Bone & Joint Journal
Vol. 101-B, Issue 5 | Pages 565 - 572
1 May 2019
Teeter MG Marsh JD Howard JL Yuan X Vasarhelyi EM McCalden RW Naudie DDR

Aims. The purpose of the present study was to compare patient-specific instrumentation (PSI) and conventional surgical instrumentation (CSI) for total knee arthroplasty (TKA) in terms of early implant migration, alignment, surgical resources, patient outcomes, and costs. . Patients and Methods. The study was a prospective, randomized controlled trial of 50 patients undergoing TKA. There were 25 patients in each of the PSI and CSI groups. There were 12 male patients in the PSI group and seven male patients in the CSI group. The patients had a mean age of 69.0 years (. sd. 8.4) in the PSI group and 69.4 years (. sd. 8.4) in the CSI group. All patients received the same TKA implant. Intraoperative surgical resources and any surgical waste generated were recorded. Patients underwent radiostereometric analysis (RSA) studies to measure femoral and tibial component migration over two years. Outcome measures were recorded pre- and postoperatively. Overall costs were calculated for each group. Results. There were no differences (p > 0.05) in any measurement of migration at two years for either the tibial or femoral components. Movement between one and two years was < 0.2 mm, indicating stable fixation. There were no differences in coronal or sagittal alignment between the two groups. The PSI group took a mean 6.1 minutes longer (p = 0.04) and used a mean 3.4 less trays (p < 0.0001). Total waste generated was similar (10 kg) between the two groups. The PSI group cost a mean CAD$1787 more per case (p < 0.01). Conclusion. RSA criteria suggest that both groups will have revision rates of approximately 3% at five years. The advantages of PSI were minimal or absent for surgical resources used and waste eliminated, and for meeting target alignment, yet had significantly greater costs. Therefore, we conclude that PSI may not offer any advantage over CSI for routine primary TKA cases. Cite this article: Bone Joint J 2019;101-B:565–572


The Bone & Joint Journal
Vol. 98-B, Issue 8 | Pages 1043 - 1049
1 Aug 2016
Huijbregts HJTAM Khan RJK Fick DP Hall MJ Punwar SA Sorensen E Reid MJ Vedove SD Haebich S

Aims. We conducted a randomised controlled trial to assess the accuracy of positioning and alignment of the components in total knee arthroplasty (TKA), comparing those undertaken using standard intramedullary cutting jigs and those with patient-specific instruments (PSI). Patients and Methods. There were 64 TKAs in the standard group and 69 in the PSI group. The post-operative hip-knee-ankle (HKA) angle and positioning was investigated using CT scans. Deviation of > 3° from the planned position was regarded as an outlier. The operating time, Oxford Knee Scores (OKS) and Short Form-12 (SF-12) scores were recorded. Results. There were 14 HKA-angle outliers (22%) in the standard group and nine (13%) in the PSI group (p = 0.251). The mean HKA-angle was 0.5° varus in the standard group and 0.2° varus in the PSI group (p = 0.492). The accuracy of alignment in the coronal and axial planes and the proportion of outliers was not different in the two groups. The femoral component was more flexed (p = 0.035) and there were significantly more tibial slope outliers (29% versus 13%) in the PSI group (p = 0.032). Operating time and the median three-month OKS were similar (p = 0.218 and p = 0.472, respectively). Physical and mental SF-12 scores were not significantly different at three months (p = 0.418 and p = 0.267, respectively) or at one year post-operatively (p = 0.114 and p = 0.569). The median one-year Oxford knee score was two points higher in the PSI group (p = 0.049). Conclusion. Compared with standard intramedullary jigs, the use of PSI did not significantly reduce the number of outliers or the mean operating time, nor did it clinically improve the accuracy of alignment or the median Oxford Knee Scores. Our data do not support the routine use of PSI when undertaking TKA. Cite this article: Bone Joint J 2016;98-B:1043–9


The Bone & Joint Journal
Vol. 96-B, Issue 8 | Pages 1052 - 1061
1 Aug 2014
Thienpont E Schwab PE Fennema P

We conducted a meta-analysis, including randomised controlled trials (RCTs) and cohort studies, to examine the effect of patient-specific instruments (PSI) on radiological outcomes after total knee replacement (TKR) including: mechanical axis alignment and malalignment of the femoral and tibial components in the coronal, sagittal and axial planes, at a threshold of > 3º from neutral. Relative risks (RR) for malalignment were determined for all studies and for RCTs and cohort studies separately. Of 325 studies initially identified, 16 met the eligibility criteria, including eight RCTs and eight cohort studies. There was no significant difference in the likelihood of mechanical axis malalignment with PSI versus conventional TKR across all studies (RR = 0.84, p = 0.304), in the RCTs (RR = 1.14, p = 0.445) or in the cohort studies (RR = 0.70, p = 0.289). The results for the alignment of the tibial component were significantly worse using PSI TKR than conventional TKR in the coronal and sagittal planes (RR = 1.75, p = 0.028; and RR = 1.34, p = 0.019, respectively, on pooled analysis). PSI TKR showed a significant advantage over conventional TKR for alignment of the femoral component in the coronal plane (RR = 0.65, p = 0.028 on pooled analysis), but not in the sagittal plane (RR = 1.12, p = 0.437). Axial alignment of the tibial (p = 0.460) and femoral components (p = 0.127) was not significantly different. We conclude that PSI does not improve the accuracy of alignment of the components in TKR compared with conventional instrumentation. Cite this article: Bone Joint J 2014; 96-B:1052–61


The Journal of Bone & Joint Surgery British Volume
Vol. 94-B, Issue 11 | Pages 1457 - 1461
1 Nov 2012
Krishnan SP Dawood A Richards R Henckel J Hart AJ

Improvements in the surgical technique of total knee replacement (TKR) are continually being sought. There has recently been interest in three-dimensional (3D) pre-operative planning using magnetic resonance imaging (MRI) and CT. The 3D images are increasingly used for the production of patient-specific models, surgical guides and custom-made implants for TKR. The users of patient-specific instrumentation (PSI) claim that they allow the optimum balance of technology and conventional surgery by reducing the complexity of conventional alignment and sizing tools. In this way the advantages of accuracy and precision claimed by computer navigation techniques are achieved without the disadvantages of additional intra-operative inventory, new skills or surgical time. This review describes the terminology used in this area and debates the advantages and disadvantages of PSI


The Bone & Joint Journal
Vol. 106-B, Issue 9 | Pages 892 - 897
1 Sep 2024
Mancino F Fontalis A Kayani B Magan A Plastow R Haddad FS

Advanced 3D imaging and CT-based navigation have emerged as valuable tools to use in total knee arthroplasty (TKA), for both preoperative planning and the intraoperative execution of different philosophies of alignment. Preoperative planning using CT-based 3D imaging enables more accurate prediction of the size of components, enhancing surgical workflow and optimizing the precision of the positioning of components. Surgeons can assess alignment, osteophytes, and arthritic changes better. These scans provide improved insights into the patellofemoral joint and facilitate tibial sizing and the evaluation of implant-bone contact area in cementless TKA. Preoperative CT imaging is also required for the development of patient-specific instrumentation cutting guides, aiming to reduce intraoperative blood loss and improve the surgical technique in complex cases. Intraoperative CT-based navigation and haptic guidance facilitates precise execution of the preoperative plan, aiming for optimal positioning of the components and accurate alignment, as determined by the surgeon’s philosophy. It also helps reduce iatrogenic injury to the periarticular soft-tissue structures with subsequent reduction in the local and systemic inflammatory response, enhancing early outcomes. Despite the increased costs and radiation exposure associated with CT-based navigation, these many benefits have facilitated the adoption of imaged based robotic surgery into routine practice. Further research on ultra-low-dose CT scans and exploration of the possible translation of the use of 3D imaging into improved clinical outcomes are required to justify its broader implementation.

Cite this article: Bone Joint J 2024;106-B(9):892–897.


The Bone & Joint Journal
Vol. 106-B, Issue 7 | Pages 680 - 687
1 Jul 2024
Mancino F Fontalis A Grandhi TSP Magan A Plastow R Kayani B Haddad FS

Aims

Robotic arm-assisted surgery offers accurate and reproducible guidance in component positioning and assessment of soft-tissue tensioning during knee arthroplasty, but the feasibility and early outcomes when using this technology for revision surgery remain unknown. The objective of this study was to compare the outcomes of robotic arm-assisted revision of unicompartmental knee arthroplasty (UKA) to total knee arthroplasty (TKA) versus primary robotic arm-assisted TKA at short-term follow-up.

Methods

This prospective study included 16 patients undergoing robotic arm-assisted revision of UKA to TKA versus 35 matched patients receiving robotic arm-assisted primary TKA. In all study patients, the following data were recorded: operating time, polyethylene liner size, change in haemoglobin concentration (g/dl), length of inpatient stay, postoperative complications, and hip-knee-ankle (HKA) alignment. All procedures were performed using the principles of functional alignment. At most recent follow-up, range of motion (ROM), Forgotten Joint Score (FJS), and Oxford Knee Score (OKS) were collected. Mean follow-up time was 21 months (6 to 36).


The Bone & Joint Journal
Vol. 104-B, Issue 5 | Pages 604 - 612
1 May 2022
MacDessi SJ Wood JA Diwan A Harris IA

Aims

Intraoperative pressure sensors allow surgeons to quantify soft-tissue balance during total knee arthroplasty (TKA). The aim of this study was to determine whether using sensors to achieve soft-tissue balance was more effective than manual balancing in improving outcomes in TKA.

Methods

A multicentre randomized trial compared the outcomes of sensor balancing (SB) with manual balancing (MB) in 250 patients (285 TKAs). The primary outcome measure was the mean difference in the four Knee injury and Osteoarthritis Outcome Score subscales (ΔKOOS4) in the two groups, comparing the preoperative and two-year scores. Secondary outcomes included intraoperative balance data, additional patient-reported outcome measures (PROMs), and functional measures.


The Bone & Joint Journal
Vol. 106-B, Issue 11 | Pages 1206 - 1215
1 Nov 2024
Fontalis A Buchalter D Mancino F Shen T Sculco PK Mayman D Haddad FS Vigdorchik J

Understanding spinopelvic mechanics is important for the success of total hip arthroplasty (THA). Despite significant advancements in appreciating spinopelvic balance, numerous challenges remain. It is crucial to recognize the individual variability and postoperative changes in spinopelvic parameters and their consequential impact on prosthetic component positioning to mitigate the risk of dislocation and enhance postoperative outcomes. This review describes the integration of advanced diagnostic approaches, enhanced technology, implant considerations, and surgical planning, all tailored to the unique anatomy and biomechanics of each patient. It underscores the importance of accurately predicting postoperative spinopelvic mechanics, selecting suitable imaging techniques, establishing a consistent nomenclature for spinopelvic stiffness, and considering implant-specific strategies. Furthermore, it highlights the potential of artificial intelligence to personalize care.

Cite this article: Bone Joint J 2024;106-B(11):1206–1215.


The Bone & Joint Journal
Vol. 106-B, Issue 2 | Pages 114 - 120
1 Feb 2024
Khatri C Metcalfe A Wall P Underwood M Haddad FS Davis ET

Total hip and knee arthroplasty (THA, TKA) are largely successful procedures; however, both have variable outcomes, resulting in some patients being dissatisfied with the outcome. Surgeons are turning to technologies such as robotic-assisted surgery in an attempt to improve outcomes. Robust studies are needed to find out if these innovations are really benefitting patients. The Robotic Arthroplasty Clinical and Cost Effectiveness Randomised Controlled Trials (RACER) trials are multicentre, patient-blinded randomized controlled trials. The patients have primary osteoarthritis of the hip or knee. The operation is Mako-assisted THA or TKA and the control groups have operations using conventional instruments. The primary clinical outcome is the Forgotten Joint Score at 12 months, and there is a built-in analysis of cost-effectiveness. Secondary outcomes include early pain, the alignment of the components, and medium- to long-term outcomes. This annotation outlines the need to assess these technologies and discusses the design and challenges when conducting such trials, including surgical workflows, isolating the effect of the operation, blinding, and assessing the learning curve. Finally, the future of robotic surgery is discussed, including the need to contemporaneously introduce and evaluate such technologies.

Cite this article: Bone Joint J 2024;106-B(2):114–120.


The Bone & Joint Journal
Vol. 104-B, Issue 7 | Pages 786 - 791
1 Jul 2022
Jenkinson MRJ Peeters W Hutt JRB Witt JD

Aims

Acetabular retroversion is a recognized cause of hip impingement and can be influenced by pelvic tilt (PT), which changes in different functional positions. Positional changes in PT have not previously been studied in patients with acetabular retroversion.

Methods

Supine and standing anteroposterior (AP) pelvic radiographs were retrospectively analyzed in 69 patients treated for symptomatic acetabular retroversion. Measurements were made for acetabular index (AI), lateral centre-edge angle (LCEA), crossover index, ischial spine sign, and posterior wall sign. The change in the angle of PT was measured both by the sacro-femoral-pubic (SFP) angle and the pubic symphysis to sacroiliac (PS-SI) index.


The Bone & Joint Journal
Vol. 106-B, Issue 5 Supple B | Pages 40 - 46
1 May 2024
Massè A Giachino M Audisio A Donis A Giai Via R Secco DC Limone B Turchetto L Aprato A

Aims

Ganz’s studies made it possible to address joint deformities on both the femoral and acetabular side brought about by Perthes’ disease. Femoral head reduction osteotomy (FHRO) was developed to improve joint congruency, along with periacetabular osteotomy (PAO), which may enhance coverage and containment. The purpose of this study is to show the clinical and morphological outcomes of the technique and the use of an implemented planning approach.

Methods

From September 2015 to December 2021, 13 FHROs were performed on 11 patients for Perthes’ disease in two centres. Of these, 11 hips had an associated PAO. A specific CT- and MRI-based protocol for virtual simulation of the corrections was developed. Outcomes were assessed with radiological parameters (sphericity index, extrusion index, integrity of the Shenton’s line, lateral centre-edge angle (LCEA), Tönnis angle), and clinical parameters (range of motion, visual analogue scale (VAS) for pain, Merle d'Aubigné-Postel score, modified Harris Hip Score (mHHS), and EuroQol five-dimension five-level health questionnaire (EQ-5D-5L)). Early and late complications were reported.


The Bone & Joint Journal
Vol. 103-B, Issue 2 | Pages 329 - 337
1 Feb 2021
MacDessi SJ Griffiths-Jones W Harris IA Bellemans J Chen DB

Aims

A comprehensive classification for coronal lower limb alignment with predictive capabilities for knee balance would be beneficial in total knee arthroplasty (TKA). This paper describes the Coronal Plane Alignment of the Knee (CPAK) classification and examines its utility in preoperative soft tissue balance prediction, comparing kinematic alignment (KA) to mechanical alignment (MA).

Methods

A radiological analysis of 500 healthy and 500 osteoarthritic (OA) knees was used to assess the applicability of the CPAK classification. CPAK comprises nine phenotypes based on the arithmetic HKA (aHKA) that estimates constitutional limb alignment and joint line obliquity (JLO). Intraoperative balance was compared within each phenotype in a cohort of 138 computer-assisted TKAs randomized to KA or MA. Primary outcomes included descriptive analyses of healthy and OA groups per CPAK type, and comparison of balance at 10° of flexion within each type. Secondary outcomes assessed balance at 45° and 90° and bone recuts required to achieve final knee balance within each CPAK type.


The Bone & Joint Journal
Vol. 103-B, Issue 9 | Pages 1449 - 1456
1 Sep 2021
Kazarian GS Lieberman EG Hansen EJ Nunley RM Barrack RL

Aims

The goal of the current systematic review was to assess the impact of implant placement accuracy on outcomes following total knee arthroplasty (TKA).

Methods

A systematic review was performed in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines using the Ovid Medline, Embase, Cochrane Central, and Web of Science databases in order to assess the impact of the patient-reported outcomes measures (PROMs) and implant placement accuracy on outcomes following TKA. Studies assessing the impact of implant alignment, rotation, size, overhang, or condylar offset were included. Study quality was assessed, evidence was graded (one-star: no evidence, two-star: limited evidence, three-star: moderate evidence, four-star: strong evidence), and recommendations were made based on the available evidence.


Aims

Patient-specific instrumentation of total knee arthroplasty (TKA) is a technique permitting the targeting of individual kinematic alignment, but deviation from a neutral mechanical axis may have implications on implant fixation and therefore survivorship. The primary objective of this randomized controlled study was to compare the fixation of tibial components implanted with patient-specific instrumentation targeting kinematic alignment (KA+PSI) versus components placed using computer-assisted surgery targeting neutral mechanical alignment (MA+CAS). Tibial component migration measured by radiostereometric analysis was the primary outcome measure (compared longitudinally between groups and to published acceptable thresholds). Secondary outcome measures were inducible displacement after one year and patient-reported outcome measures (PROMS) over two years. The secondary objective was to assess the relationship between alignment and both tibial component migration and inducible displacement.

Patients and Methods

A total of 47 patients due to undergo TKA were randomized to KA+PSI (n = 24) or MA+CAS (n = 23). In the KA+PSI group, there were 16 female and eight male patients with a mean age of 64 years (sd 8). In the MA+CAS group, there were 17 female and six male patients with a mean age of 63 years (sd 7). Surgery was performed using cemented, cruciate-retaining Triathlon total knees with patellar resurfacing, and patients were followed up for two years. The effect of alignment on tibial component migration and inducible displacement was analyzed irrespective of study group.


The Bone & Joint Journal
Vol. 102-B, Issue 6 Supple A | Pages 43 - 48
1 Jun 2020
D’Lima DP Huang P Suryanarayan P Rosen A D’Lima DD

Aims

The extensive variation in axial rotation of tibial components can lead to coronal plane malalignment. We analyzed the change in coronal alignment induced by tray malrotation.

Methods

We constructed a computer model of knee arthroplasty and used a virtual cutting guide to cut the tibia at 90° to the coronal plane. The virtual guide was rotated axially (15° medial to 15° lateral) and with posterior slopes (0° to 7°). To assess the effect of axial malrotation, we measured the coronal plane alignment of a tibial tray that was axially rotated (25° internal to 15° external), as viewed on a standard anteroposterior (AP) radiograph.


The Bone & Joint Journal
Vol. 101-B, Issue 7_Supple_C | Pages 115 - 120
1 Jul 2019
Hooper J Schwarzkopf R Fernandez E Buckland A Werner J Einhorn T Walker PS

Aims

This aim of this study was to assess the feasibility of designing and introducing generic 3D-printed instrumentation for routine use in total knee arthroplasty.

Materials and Methods

Instruments were designed to take advantage of 3D-printing technology, particularly ensuring that all parts were pre-assembled, to theoretically reduce the time and skill required during surgery. Concerning functionality, ranges of resection angle and distance were restricted within a safe zone, while accommodating either mechanical or anatomical alignment goals. To identify the most suitable biocompatible materials, typical instrument shapes and mating parts, such as dovetails and screws, were designed and produced.


The Bone & Joint Journal
Vol. 100-B, Issue 1 | Pages 88 - 94
1 Jan 2018
Sprague S Petrisor B Jeray K McKay P Heels-Ansdell D Schemitsch E Liew S Guyatt G Walter SD Bhandari M

Aims

The Fluid Lavage in Open Fracture Wounds (FLOW) trial was a multicentre, blinded, randomized controlled trial that used a 2 × 3 factorial design to evaluate the effect of irrigation solution (soap versus normal saline) and irrigation pressure (very low versus low versus high) on health-related quality of life (HRQL) in patients with open fractures. In this study, we used this dataset to ascertain whether these factors affect whether HRQL returns to pre-injury levels at 12-months post-injury.

Patients and Methods

Participants completed the Short Form-12 (SF-12) and the EuroQol-5 Dimensions (EQ-5D) at baseline (pre-injury recall), at two and six weeks, and at three, six, nine and 12-months post-fracture. We calculated the Physical Component Score (PCS) and the Mental Component Score (MCS) of the SF-12 and the EQ-5D utility score, conducted an analysis using a multi-level generalized linear model, and compared differences between the baseline and 12-month scores.