Advertisement for orthosearch.org.uk
Results 1 - 20 of 40
Results per page:
The Bone & Joint Journal
Vol. 102-B, Issue 8 | Pages 1025 - 1032
1 Aug 2020
Hampton M Mansoor J Getty J Sutton PM

Aims

Total knee arthroplasty is an established treatment for knee osteoarthritis with excellent long-term results, but there remains controversy about the role of uncemented prostheses. We present the long-term results of a randomized trial comparing an uncemented tantalum metal tibial component with a conventional cemented component of the same implant design.

Methods

Patients under the age of 70 years with symptomatic osteoarthritis of the knee were randomized to receive either an uncemented tantalum metal tibial monoblock component or a standard cemented modular component. The mean age at time of recruitment to the study was 63 years (50 to 70), 46 (51.1%) knees were in male patients, and the mean body mass index was 30.4 kg/m2 (21 to 36). The same cruciate retaining total knee system was used in both groups. All patients received an uncemented femoral component and no patients had their patella resurfaced. Patient outcomes were assessed preoperatively and postoperatively using the modified Oxford Knee Score, Knee Society Score, and 12-Item Short-Form Health Survey questionnaire (SF-12) score. Radiographs were analyzed using the American Knee Society Radiograph Evaluation score. Operative complications, reoperations, or revision surgery were recorded. A total of 90 knees were randomized and at last review 77 knees were assessed. In all, 11 patients had died and two were lost to follow-up.


The Bone & Joint Journal
Vol. 100-B, Issue 12 | Pages 1579 - 1584
1 Dec 2018
Turgeon TR Gascoyne TC Laende EK Dunbar MJ Bohm ER Richardson CG

Aims

The introduction of a novel design of total knee arthroplasty (TKA) must achieve outcomes at least as good as existing designs. A novel design of TKA with a reducing radius of the femoral component and a modified cam-post articulation has been released and requires assessment of the fixation to bone. Radiostereometric analysis (RSA) of the components within the first two postoperative years has been shown to be predictive of medium- to long-term fixation. The aim of this study was to assess the stability of the tibial component of this system during this period of time using RSA.

Patients and Methods

A cohort of 30 patients underwent primary, cemented TKA using the novel posterior stabilized fixed-bearing (ATTUNE) design. There was an even distribution of men and women (15:15). The mean age of the patients was 64 years (sd 8) at the time of surgery; their mean body mass index (BMI) was 35.4 kg/m2 (sd 7.9). RSA was used to assess the stability of the tibial component at 6, 12, and 24 months compared with a six-week baseline examination. Patient-reported outcome measures were also assessed.


The Bone & Joint Journal
Vol. 102-B, Issue 8 | Pages 1048 - 1055
1 Aug 2020
Cox I Al Mouazzen L Bleibleh S Moldovan R Bintcliffe F Bache CE Thomas S

Aims. The Fassier Duval (FD) rod is a third-generation telescopic implant for children with osteogenesis imperfecta (OI). Threaded fixation enables proximal insertion without opening the knee or ankle joint. We have reviewed our combined two-centre experience with this implant. Methods. In total, 34 children with a mean age of five years (1 to 14) with severe OI have undergone rodding of 72 lower limb long bones (27 tibial, 45 femoral) for recurrent fractures with progressive deformity despite optimized bone health and bisphosphonate therapy. Data were collected prospectively, with 1.5 to 11 years follow-up. Results. A total of 24 patients (33%) required exchange of implants (14 femora and ten tibiae) including 11 rods bending with refracture. Four (5%) required reoperation with implant retention. Loss of proximal fixation in the femur and distal fixation in the tibia were common. Four patients developed coxa vara requiring surgical correction. In total, 13 patients experienced further fractures without rod bending; eight required implant revision. There was one deep infection. The five-year survival rate, with rod revision as the endpoint, was 63% (95% confidence interval (CI) 44% to 77%) for femoral rods, with a mean age at implantation of 4.8 years (1.3 to 14.8), and 64% (95% CI 36% to 82%) for tibial rods, with a mean age at implantation of 5.2 years (2.0 to 13.8). Conclusion. FD rods are easier to implant but do not improve on the revision rates reported for second generation T-piece rods. Proximal femoral fixation is problematic in younger children with a partially ossified greater trochanter. Distal tibial fixation typically fails after two years. Future generation implants should address proximal femoral and distal tibial fixation to avoid the majority of complications in this series. Cite this article: Bone Joint J 2020;102-B(8):1048–1055


The Bone & Joint Journal
Vol. 103-B, Issue 6 Supple A | Pages 150 - 157
1 Jun 2021
Anderson LA Christie M Blackburn BE Mahan C Earl C Pelt CE Peters CL Gililland J

Aims. Porous metaphyseal cones can be used for fixation in revision total knee arthroplasty (rTKA) and complex TKAs. This metaphyseal fixation has led to some surgeons using shorter cemented stems instead of diaphyseal engaging cementless stems with a potential benefit of ease of obtaining proper alignment without being beholden to the diaphysis. The purpose of this study was to evaluate short term clinical and radiographic outcomes of a series of TKA cases performed using 3D-printed metaphyseal cones. Methods. A retrospective review of 86 rTKAs and nine complex primary TKAs, with an average age of 63.2 years (SD 8.2) and BMI of 34.0 kg/m. 2. (SD 8.7), in which metaphyseal cones were used for both femoral and tibial fixation were compared for their knee alignment based on the type of stem used. Overall, 22 knees had cementless stems on both sides, 52 had cemented stems on both sides, and 15 had mixed stems. Postoperative long-standing radiographs were evaluated for coronal and sagittal plane alignment. Adjusted logistic regression models were run to assess malalignment hip-knee-ankle (HKA) alignment beyond ± 3° and sagittal alignment of the tibial and femoral components ± 3° by stem type. Results. No patients had a revision of a cone due to aseptic loosening; however, two had revision surgery due to infection. In all, 26 (27%) patients had HKA malalignment; nine (9.5%) patients had sagittal plane malalignment, five (5.6%) of the tibia, and four (10.8%) of the femur. After adjusting for age, sex, and BMI, there was a significantly increased risk for malalignment when a cone was used and both the femur and tibia had cementless compared to cemented stems (odds ratio 3.19, 95% confidence interval 1.01 to 10.05). Conclusion. Porous 3D-printed cones provide excellent metaphyseal fixation. However, these central cones make the use of offset couplers difficult and may generate malalignment with cementless stems. We found 3.19-times higher odds of malalignment in our TKAs performed with metaphyseal cones and both femoral and tibial cementless stems. Cite this article: Bone Joint J 2021;103-B(6 Supple A):150–157


The Bone & Joint Journal
Vol. 102-B, Issue 7 | Pages 861 - 867
1 Jul 2020
Hiranaka T Yoshikawa R Yoshida K Michishita K Nishimura T Nitta S Takashiba K Murray D

Aims. Cementless unicompartmental knee arthroplasty (UKA) has advantages over cemented UKA, including improved fixation, but has a higher risk of tibial plateau fracture, particularly in Japanese patients. The aim of this multicentre study was to determine when cementless tibial components could safely be used in Japanese patients based on the size and shape of the tibia. Methods. The study involved 212 cementless Oxford UKAs which were undertaken in 174 patients in six hospitals. The medial eminence line (MEL), which is a line parallel to the tibial axis passing through the tip of medial intercondylar eminence, was drawn on preoperative radiographs. Knees were classified as having a very overhanging medial tibial condyle if this line passed medial to the medial tibial cortex. They were also classified as very small if a size A/AA tibial component was used. Results. The overall rate of fracture was 8% (17 out of 212 knees). The rate was higher in knees with very overhanging condyles (Odds ratio (OR) 13; p < 0.001) and with very small components (OR 7; p < 0.001). The OR was 21 (p < 0.001) in those with both very overhanging condyles and very small components. In all, 69% of knees (147) had neither very overhanging nor very small components, and the fracture rate in these patients was 1.4% (2 out of 147 knees). Males had a significantly reduced risk of fracture (OR 0.13; p = 0.002), probably because no males required very small components and females were more likely to have very overhanging condyles (OR 3; p = 0.013). 31% of knees (66) were in males and in these the rate of fracture was 1.5% (1 out of 66 knees). Conclusion. The rate of tibial plateau fracture in Japanese patients undergoing cementless UKA is high. We recommend that cemented tibial fixation should be used in Japanese patients who require very small components or have very overhanging condyles, as identified from preoperative radiographs. In the remaining 69% of knees cementless fixation can be used. This approach should result in a low rate of fracture. Cite this article: Bone Joint J 2020;102-B(7):861–867


The Bone & Joint Journal
Vol. 105-B, Issue 10 | Pages 1099 - 1107
1 Oct 2023
Henry JK Shaffrey I Wishman M Palma Munita J Zhu J Cody E Ellis S Deland J Demetracopoulos C

Aims

The Vantage Total Ankle System is a fourth-generation low-profile fixed-bearing implant that has been available since 2016. We aimed to describe our early experience with this implant.

Methods

This is a single-centre retrospective review of patients who underwent primary total ankle arthroplasty (TAA) with a Vantage implant between November 2017 and February 2020, with a minimum of two years’ follow-up. Four surgeons contributed patients. The primary outcome was reoperation and revision rate of the Vantage implant at two years. Secondary outcomes included radiological alignment, peri-implant complications, and pre- and postoperative patient-reported outcomes.


The Bone & Joint Journal
Vol. 105-B, Issue 10 | Pages 1078 - 1085
1 Oct 2023
Cance N Batailler C Shatrov J Canetti R Servien E Lustig S

Aims

Tibial tubercle osteotomy (TTO) facilitates surgical exposure and protects the extensor mechanism during revision total knee arthroplasty (rTKA). The purpose of this study was to determine the rates of bony union, complications, and reoperations following TTO during rTKA, to assess the functional outcomes of rTKA with TTO at two years’ minimum follow-up, and to identify the risk factors of failure.

Methods

Between January 2010 and September 2020, 695 rTKAs were performed and data were entered into a prospective database. Inclusion criteria were rTKAs with concomitant TTO, without extensor mechanism allograft, and a minimum of two years’ follow-up. A total of 135 rTKAs were included, with a mean age of 65 years (SD 9.0) and a mean BMI of 29.8 kg/m2 (SD 5.7). The most frequent indications for revision were infection (50%; 68/135), aseptic loosening (25%; 34/135), and stiffness (13%; 18/135). Patients had standardized follow-up at six weeks, three months, six months, and annually thereafter. Complications and revisions were evaluated at the last follow-up. Functional outcomes were assessed using the Knee Society Score (KSS) and range of motion.


The Bone & Joint Journal
Vol. 105-B, Issue 11 | Pages 1168 - 1176
1 Nov 2023
Yüksel Y Koster LA Kaptein BL Nelissen RGHH den Hollander P

Aims

Conflicting clinical results are reported for the ATTUNE Total Knee Arthroplasty (TKA). This randomized controlled trial (RCT) evaluated five-year follow-up results comparing cemented ATTUNE and PFC-Sigma cruciate retaining TKAs, analyzing component migration as measured by radiostereometric analysis (RSA), clinical outcomes, patient-reported outcome measures (PROMs), and radiological outcomes.

Methods

A total of 74 primary TKAs were included in this single-blind RCT. RSA examinations were performed, and PROMs and clinical outcomes were collected immediate postoperatively, and at three, six, 12, 24, and 60 months’ follow-up. Radiolucent lines (RLLs) were measured in standard anteroposterior radiographs at six weeks, and 12 and 60 months postoperatively.


The Bone & Joint Journal
Vol. 104-B, Issue 6 | Pages 680 - 686
1 Jun 2022
Robinson JR Bruce D Davies H Porteous AJ Murray JRD Howells NR

Aims

The best surgical strategy for the management of displaced bucket-handle (BH) meniscal tears in an anterior cruciate ligament (ACL)-deficient knee is unclear. Combining meniscal repair with ACL reconstruction (ACLR) is thought to improve meniscal healing rates; however, patients with displaced BH meniscal tears may lack extension. This leads some to advocate staged surgery to avoid postoperative stiffness and loss of range of motion (ROM) following ACLR.

Methods

We reviewed the data for a consecutive series of 88 patients (mean age 27.1 years (15 to 49); 65 male (74%) and 23 female (26%)) who underwent single-stage repair of a displaced BH meniscal tear (67 medial (76%) and 21 lateral (24%)) with concomitant hamstring autograft ACLR. The patient-reported outcome measures (PROMs) EuroQol visual analogue scale (EQ-VAS), EuroQol five-dimension health questionnaire (EQ-5D), Knee injury and Osteoarthritis Outcome Score (KOOS), International Knee Documentation Committee score (IKDC), and Tegner score were recorded at final follow-up. A Kaplan-Meier survival analysis was performed to estimate meniscal repair survivorship. Analyses were performed with different cut-offs for meniscal and ACL injury-to-surgery time (within three weeks, three to ten weeks, and more than ten weeks).


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. 104-B, Issue 1 | Pages 34 - 44
1 Jan 2022
Beckers L Dandois F Ooms D Berger P Van Laere K Scheys L Vandenneucker H

Aims

Higher osteoblastic bone activity is expected in aseptic loosening and painful unicompartmental knee arthroplasty (UKA). However, insights into normal bone activity patterns after medial UKAs are lacking. The aim of this study was to identify the evolution in bone activity pattern in well-functioning medial mobile-bearing UKAs.

Methods

In total, 34 patients (13 female, 21 male; mean age 62 years (41 to 79); BMI 29.7 kg/m2 (23.6 to 42.1)) with 38 medial Oxford partial UKAs (20 left, 18 right; 19 cementless, 14 cemented, and five hybrid) were prospectively followed with sequential 99mTc-hydroxymethane diphosphonate single photon emission CT (SPECT)/CT preoperatively, and at one and two years postoperatively. Changes in mean osteoblastic activity were investigated using a tracer localization scheme with volumes of interest (VOIs), reported by normalized mean tracer values. A SPECT/CT registration platform additionally explored cortical tracer evolution in zones of interest identified by previous experimental research.


The Bone & Joint Journal
Vol. 103-B, Issue 10 | Pages 1555 - 1560
4 Oct 2021
Phillips JRA Tucker K

Aims

Knee arthroplasty surgery is a highly effective treatment for arthritis and disorders of the knee. There are a wide variety of implant brands and types of knee arthroplasty available to surgeons. As a result of a number of highly publicized failures, arthroplasty surgery is highly regulated in the UK and many other countries through national registries, introduced to monitor implant performance, surgeons, and hospitals. With time, the options available within many brand portfolios have grown, with alternative tibial or femoral components, tibial insert materials, or shapes and patella resurfacings. In this study we have investigated the effect of the expansion of implant brand portfolios and where there may be a lack of transparency around a brand name. We also aimed to establish the potential numbers of compatible implant construct combinations.

Methods

Hypothetical implant brand portfolios were proposed, and the number of compatible implant construct combinations was calculated.


The Journal of Bone & Joint Surgery British Volume
Vol. 91-B, Issue 10 | Pages 1310 - 1315
1 Oct 2009
Ibrahim SAR Hamido F Al Misfer AK Mahgoob A Ghafar SA Alhran H

A total of 218 patients with unilateral anterior cruciate ligament deficiency were randomly assigned to one of four groups. In group A an anatomical double bundle anterior cruciate ligament reconstruction was performed; group B were treated by a single bundle using an Endobutton for femoral fixation; in group C by a single bundle using RigidFix cross pins for femoral fixation; and in group D by a single bundle using a bioabsorbable TransFix II screw for femoral fixation. For tibial fixation a bioabsorbable Intrafix interference screw was used for all the groups and the graft was fashioned from the semitendinosus and gracilis tendons in all patients. In all, 18 patients were lost to follow-up. The remaining 200 were subjected to a clinical evaluation, with assessment of the anterior drawer, Lachman’s and the pivot-shift tests, and KT-1000 arthrometer measurement. They also completed the International Knee Documentation Committee, Lysholm knee and Tegner activity scores. At a mean of 29 months (25 to 38) follow-up there were no significant differences concerning time between injury and range of movement and Lysholm knee scores among the four groups. However, the double bundle method showed significantly better results for the pivot-shift test (p = 0.002). The KT 1000 measurements showed a mean difference between the reconstructed knee and the patients’ normal knee of 1.4 mm in the double bundle group and 2.4 mm in the single bundle group; which was statistically significant. The Lachman and anterior drawer tests also showed superior results for the double bundle method. The International Knee Documentation Committee scale showed no significant difference among the groups (p < 0.001). On clinical evaluation the double bundle group showed less laxity than the single bundle groups. However, regardless of the technique, all knees were improved by anterior cruciate ligament reconstruction compared with their pre-operative status


The Bone & Joint Journal
Vol. 103-B, Issue 5 | Pages 809 - 812
1 May 2021
Farhan-Alanie MM Trompeter AJ Wall PDH Costa ML

The use of tourniquets in lower limb trauma surgery to control bleeding and improve the surgical field is a long established practice. In this article, we review the evidence relating to harms and benefits of tourniquet use in lower limb fracture fixation surgery and report the results of a survey on current tourniquet practice among trauma surgeons in the UK.


The Bone & Joint Journal
Vol. 103-B, Issue 6 Supple A | Pages 137 - 144
1 Jun 2021
Lachiewicz PF Steele JR Wellman SS

Aims

To establish our early clinical results of a new total knee arthroplasty (TKA) tibial component introduced in 2013 and compare it to other designs in use at our hospital during the same period.

Methods

This is a retrospective study of 166 (154 patients) consecutive cemented, fixed bearing, posterior-stabilized (PS) TKAs (ATTUNE) at one hospital performed by five surgeons. These were compared with a reference cohort of 511 knees (470 patients) of other designs (seven manufacturers) performed at the same hospital by the same surgeons. There were no significant differences in age, sex, BMI, or follow-up times between the two cohorts. The primary outcome was revision performed or pending.


The Bone & Joint Journal
Vol. 103-B, Issue 5 | Pages 840 - 845
1 May 2021
Rossi SMP Perticarini L Clocchiatti S Ghiara M Benazzo F

Aims

In the last decade, interest in partial knee arthroplasties and bicruciate retaining total knee arthroplasties has increased. In addition, patient-related outcomes and functional results such as range of movement and ambulation may be more promising with less invasive procedures such as bicompartmental arthroplasty (BCA). The purpose of this study is to evaluate clinical and radiological outcomes after a third-generation patellofemoral arthroplasty (PFA) combined with a medial or lateral unicompartmental knee arthroplasty (UKA) at mid- to long-term follow-up.

Methods

A total of 57 procedures were performed. In 45 cases, a PFA was associated with a medial UKA and, in 12, with a lateral UKA. Patients were followed with validated patient-reported outcome measures (Oxford Knee Score (OKS), EuroQol five-dimension questionnaire (EQ-5D), EuroQoL Visual Analogue Scale (EQ-VAS)), the Knee Society Score (KSS), the Forgotten Joint Score (FJS), and radiological analysis.


The Journal of Bone & Joint Surgery British Volume
Vol. 80-B, Issue 3 | Pages 417 - 425
1 May 1998
Önsten I Nordqvist A Carlsson ÅS Besjakov J Shott S

In a single-blind, randomised series of knee replacements in 116 patients, we used radiostereometric analysis (RSA) to measure micromotion in three types of tibial implant fixation for two years after knee replacement. We compared hydroxyapatite-augmented porous coating, porous coating, and cemented fixation of the same design of tibial component. At one to two years, porous-coated implants migrated at a statistically significantly higher rate than hydroxyapatite-augmented or cemented implants. There was no significant difference between hydroxyapatite-coated and cemented implants. We conclude that hydroxyapatite augmentation may offer a clinically relevant advantage over a simple porous coating for tibial component fixation, but is no better than cemented fixation


The Journal of Bone & Joint Surgery British Volume
Vol. 75-B, Issue 6 | Pages 950 - 955
1 Nov 1993
Harvey I Barry K Kirby S Johnson R Elloy M

We have investigated those factors which influence the range of movement after total knee arthroplasty, including sex, age, preoperative diagnosis and preoperative flexion deformity and flexion range. We also compared cemented and cementless tibial fixation, the influence of collateral ligament and lateral parapatellar releases and of replacement of the patella, and of the period of postoperative immobilisation. We reviewed 516 Johnson-Elloy (Accord) knee arthroplasties performed between 1982 and 1989, with a minimum follow-up of 12 months. The most important factors in the range of flexion achieved after arthroplasty are the diagnosis and the preoperative range of flexion. In patients with osteoarthritis there was a mean loss of flexion; in rheumatoid arthritis there was a mean gain. In both groups, the stiffer knees gained motion and the more mobile knees lost it. Post-operative range of motion was not influenced significantly by cement fixation, collateral ligament or patellar retinacular releases, prolonged immobilisation or patellar replacement


The Bone & Joint Journal
Vol. 99-B, Issue 11 | Pages 1467 - 1476
1 Nov 2017
van Hamersveld KT Marang-van de Mheen PJ Tsonaka R Valstar† ER Toksvig-Larsen S

Aims. The optimal method of tibial component fixation remains uncertain in total knee arthroplasty (TKA). Hydroxyapatite coatings have been applied to improve bone ingrowth in uncemented designs, but may only coat the directly accessible surface. As peri-apatite (PA) is solution deposited, this may increase the coverage of the implant surface and thereby fixation. We assessed the tibial component fixation of uncemented PA-coated TKAs versus cemented TKAs. Patients and Methods. Patients were randomised to PA-coated or cemented TKAs. In 60 patients (30 in each group), radiostereometric analysis of tibial component migration was evaluated as the primary outcome at baseline, three months post-operatively and at one, two and five years. A linear mixed-effects model was used to analyse the repeated measurements. Results. After five years of follow-up, one (cemented) component was revised due to ligament instability. Overall, uncemented PA-coated tibial components migrated significantly more (p = 0.003), with the mean maximum total point motion (MTPM) at five years being 0.62 mm (95% confidence intervals (CI) 0.49 to 0.76) for cemented tibial components and 0.97 mm (95% CI 0.81 to 1.15) for PA-coated tibial components in TKA. However, between three months and five years the cemented TKAs migrated significantly more (p = 0.02), displaying a MTPM of 0.27 mm (95% CI, 0.19 to 0.36) versus 0.13 mm (95% CI, 0.01 to 0.25) for PA-coated tibial components. One implant in each group was considered at risk for aseptic loosening due to continuous migration after five years of follow-up, albeit with different migration patterns for each group (i.e. higher initial migration but diminishing over time for the PA-coated component versus gradually increasing migration for the cemented component). Conclusion. The tibial components of PA-coated TKAs showed more overall migration compared with the tibial components of cemented TKAs. However, post hoc analysis showed that this difference was caused by higher migration of PA-coated components in the first three months, after which a stable migration pattern was observed. Clinically, there was no significant difference in outcome between the groups. Cite this article: Bone Joint J 2017;99-B:1467–76


The Bone & Joint Journal
Vol. 102-B, Issue 7 | Pages 852 - 860
1 Jul 2020
Zamora T Garbuz DS Greidanus NV Masri BA

Aims

Our objective is to describe our early and mid-term results with the use of a new simple primary knee prosthesis as an articulating spacer in planned two-stage management for infected knee arthroplasty. As a second objective, we compared outcomes between the group with a retained first stage and those with a complete two-stage revision.

Methods

We included 47 patients (48 knees) with positive criteria for infection, with a minimum two-year follow-up, in which a two-stage approach with an articulating spacer with new implants was used. Patients with infection control, and a stable and functional knee were allowed to retain the initial first-stage components. Outcomes recorded included: infection control rate, reoperations, final range of motion (ROM), and quality of life assessment (QoL) including Western Ontario and McMaster Universities osteoarthritis index, Knee Injury and Osteoarthritis Outcome Score, Oxford Knee Score, 12-Item Short-Form Health Survey questionnaire, and University of California Los Angeles (UCLA) activity score and satisfaction score. These outcomes were evaluated and compared to additional cohorts of patients with retained first-stage interventions and those with a complete two-stage revision. Mean follow-up was 3.7 years (2.0 to 6.5).