Aims. The mean age of patients undergoing total knee arthroplasty (TKA) has reduced with time. Younger patients have increased expectations following TKA. Aseptic loosening of the tibial component is the most common cause of failure of TKA in the UK. Interest in cementless TKA has re-emerged due to its encouraging results in the younger patient population. We review a large series of
Objectives. We sought to determine if a durable bilayer implant composed of trabecular metal with autologous periosteum on top would be suitable to reconstitute large osteochondral defects. This design would allow for secure implant fixation, subsequent integration and remodeling. Materials and Methods. Adult sheep were randomly assigned to one of three groups (n = 8/group): 1. trabecular metal/periosteal graft (TMPG), 2. trabecular metal (TM), 3. empty defect (ED). Cartilage and bone healing were assessed macroscopically, biochemically (type II collagen, sulfated glycosaminoglycan (sGAG) and double-stranded DNA (dsDNA) content) and histologically. Results. At 16 weeks post-operatively, histological scores amongst treatment groups were not statistically different (TMPG: overall 12.7, cartilage 8.6, bone 4.1; TM: overall 14.2, cartilage 9.5, bone 4.9; ED: overall 13.6, cartilage 9.1, bone 4.5). Metal scaffolds were incorporated into the surrounding bone, both in TM and TMPG. The sGAG yield was lower in the neo-cartilage regions compared with the articular cartilage (AC) controls (TMPG 20.8/AC 39.5, TM 25.6/AC 33.3, ED 32.2/AC 40.2 µg sGAG/1 mg respectively), with statistical significance being achieved for the TMPG group (p < 0.05). Hypercellularity of the neo-cartilage was found in TM and ED, as the dsDNA content was significantly higher (p < 0.05) compared with contralateral AC controls (TM 126.7/AC 71.1, ED 99.3/AC 62.8 ng dsDNA/1 mg). The highest type II collagen content was found in neo-cartilage after TM compared with TMPG and ED (TM 60%/TMPG 40%/ED 39%). Inter-treatment differences were not significant. Conclusions. TM is a highly suitable material for the reconstitution of osseous defects. TM enables excellent bony ingrowth and fast integration. However, combined with autologous periosteum, such a biocomposite failed to promote satisfactory neo-cartilage formation. Cite this article: E. H. Mrosek, H-W. Chung, J. S. Fitzsimmons, S. W. O’Driscoll, G. G. Reinholz, J. C. Schagemann. Porous
Aims. Micromotion of the polyethylene (PE) inlay may contribute to backside PE wear in addition to articulate wear of total knee arthroplasty (TKA). Using radiostereometric analysis (RSA) with
Aims. The value of core decompression (CD) in the treatment of osteonecrosis of the femoral head (ONFH) remains controversial. We conducted a systematic review and meta-analysis to evaluate whether CD combined with other treatments could improve the clinical and radiological outcomes of ONFH patients compared with CD alone. Methods. We searched the PubMed, Embase, Web of Science, and Cochrane Library databases until June 2020. All randomized controlled trials (RCTs) and clinical controlled trials (CCTs) comparing CD alone and CD combined with other measures (CD + cell therapy, CD + bone grafting, CD + porous
Objective. Cement thickness of at least 2 mm is generally associated with more favorable results for the femoral component in cemented hip arthroplasty. However, French-designed stems have shown favorable outcomes even with thin cement mantle. The biomechanical behaviors of a French stem, Charnley-Marcel-Kerboull (CMK) and cement were researched in this study. Methods. Six polished CMK stems were implanted into a composite femur, and one million times dynamic loading tests were performed. Stem subsidence and the compressive force at the bone-cement interface were measured.
Objectives. Favourable results for collarless polished tapered stems have been reported, and cement creep due to taper slip may be a contributing factor. However, the ideal cement thickness around polished stems remains unknown. We investigated the influence of cement thickness on stem subsidence and cement creep. Methods. We cemented six collarless polished tapered (CPT) stems (two stems each of small, medium and large sizes) into composite femurs that had been reamed with a large CPT rasp to achieve various thicknesses of the cement mantle. Two or three
The December 2015 Knee Roundup360 looks at: Albumin and complications in knee arthroplasty;
The April 2015 Hip &
Pelvis Roundup. 360 . looks at: Goal-directed fluid therapy in hip fracture; Liberal blood transfusion no benefit in the longer term; Repeated measures: increased accuracy or compounded errors?; Peri-acetabular osteotomy safer than perhaps thought?; Obesity and peri-acetabular osteotomy: poor bedfellows; Stress fracture in peri-acetabular osteotomy; Infection and
The April 2015 Foot &
Ankle Roundup. 360 . looks at: Plantar pressures linked to radiographs; Strength training for ankle instability?; Is weight loss good for your feet?; Diabetes and foot surgery complications;
Objectives. To validate the precision of digitally reconstructed radiograph (DRR) radiostereometric analysis (RSA) and the model-based method (MBM) RSA with respect to benchmark marker-based (MM) RSA for evaluation of kinematics in the native hip joint. Methods. Seven human cadaveric hemipelves were CT scanned and bone models were segmented.
The August 2013 Hip &
Pelvis Roundup. 360 . looks at: are we getting it right first time?;
Objectives. Static radiostereometric analysis (RSA) using implanted markers is considered the most accurate system for the evaluation of prosthesis migration. By using CT bone models instead of markers, combined with a dynamic RSA system, a non-invasive measurement of joint movement is enabled. This method is more accurate than current 3D skin marker-based tracking systems. The purpose of this study was to evaluate the accuracy of the CT model method for measuring knee joint kinematics in static and dynamic RSA using the marker method as the benchmark. Methods. Bone models were created from CT scans, and
Despite limited clinical scientific backing, an additional trochanteric stabilizing plate (TSP) has been advocated when treating unstable trochanteric fractures with a sliding hip screw (SHS). We aimed to explore whether the TSP would result in less post operative fracture motion, compared to SHS alone. Overall, 31 patients with AO/OTA 31-A2 trochanteric fractures were randomized to either a SHS alone or a SHS with an additional TSP. To compare postoperative fracture motion, radiostereometric analysis (RSA) was performed before and after weightbearing, and then at four, eight, 12, 26, and 52 weeks. With the “after weightbearing” images as baseline, we calculated translations and rotations, including shortening and medialization of the femoral shaft.Aims
Methods
Instability is a common cause of failure after total hip arthroplasty. A novel reverse total hip has been developed, with a femoral cup and acetabular ball, creating enhanced mechanical stability. The purpose of this study was to assess the implant fixation using radiostereometric analysis (RSA), and the clinical safety and efficacy of this novel design. Patients with end-stage osteoarthritis were enrolled in a prospective cohort at a single centre. The cohort consisted of 11 females and 11 males with mean age of 70.6 years (SD 3.5) and BMI of 31.0 kg/m2 (SD 5.7). Implant fixation was evaluated using RSA as well as Western Ontario and McMaster Universities Osteoarthritis Index, Harris Hip Score, Oxford Hip Score, Hip disability and Osteoarthritis Outcome Score, 38-item Short Form survey, and EuroQol five-dimension health questionnaire scores at two-year follow-up. At least one acetabular screw was used in all cases. RSA markers were inserted into the innominate bone and proximal femur with imaging at six weeks (baseline) and six, 12, and 24 months. Independent-samples Aims
Methods
The primary outcome was investigating differences in wear, as measured by femoral head penetration, between cross-linked vitamin E-diffused polyethylene (vE-PE) and cross-linked polyethylene (XLPE) acetabular component liners and between 32 and 36 mm head sizes at the ten-year follow-up. Secondary outcomes included acetabular component migration and patient-reported outcome measures (PROMs) such as the EuroQol five-dimension questionnaire, 36-Item Short-Form Health Survey, Harris Hip Score, and University of California, Los Angeles Activity Scale (UCLA). A single-blinded, multi-arm, 2 × 2 factorial randomized controlled trial was undertaken. Patients were recruited between May 2009 and April 2011. Radiostereometric analyses (RSAs) were performed from baseline to ten years. Of the 220 eligible patients, 116 underwent randomization, and 82 remained at the ten-year follow-up. Eligible patients were randomized into one of four interventions: vE-PE acetabular liner with either 32 or 36 mm femoral head, and XLPE acetabular liner with either 32 or 36 mm femoral head. Parameters were otherwise identical except for acetabular liner material and femoral head size.Aims
Methods
Radiostereometric analysis (RSA) is the most accurate radiological method to measure in vivo wear of highly cross-linked polyethylene (XLPE) acetabular components. We have previously reported very low wear rates for a sequentially irradiated and annealed X3 XLPE liner (Stryker Orthopaedics, USA) when used in conjunction with a 32 mm femoral heads at ten-year follow-up. Only two studies have reported the long-term wear rate of X3 liners used in conjunction with larger heads using plain radiographs which have poor sensitivity. The aim of this study was to measure the ten-year wear of thin X3 XLPE liners against larger 36 or 40 mm articulations with RSA. We prospectively reviewed 19 patients who underwent primary cementless THA with the XLPE acetabular liner (X3) and a 36 or 40 mm femoral head with a resultant liner thickness of at least 5.8 mm. RSA radiographs at one week, six months, and one, two, five, and ten years postoperatively and femoral head penetration within the acetabular component were measured with UmRSA software. Of the initial 19 patients, 12 were available at the ten-year time point.Aims
Methods
A novel enhanced cement fixation (EF) tibial implant with deeper cement pockets and a more roughened bonding surface was released to market for an existing total knee arthroplasty (TKA) system.This randomized controlled trial assessed fixation of the both the EF (ATTUNE S+) and standard (Std; ATTUNE S) using radiostereometric analysis. Overall, 50 subjects were randomized (21 EF-TKA and 23 Std-TKA in the final analysis), and had follow-up visits at six weeks, and six, 12, and 24 months to assess migration of the tibial component. Low viscosity bone cement with tobramycin was used in a standardized fashion for all subjects. Patient-reported outcome measure data was captured at preoperative and all postoperative visits.Aims
Methods
The Exeter short stem was designed for patients with Dorr type A femora and short-term results are promising. The aim of this study was to evaluate the minimum five-year stem migration pattern of Exeter short stems in comparison with Exeter standard stems. In this case-control study, 25 patients (22 female) at mean age of 78 years (70 to 89) received cemented Exeter short stem (case group). Cases were selected based on Dorr type A femora and matched first by Dorr type A and then age to a control cohort of 21 patients (11 female) at mean age of 74 years (70 to 89) who received with cemented Exeter standard stems (control group). Preoperatively, all patients had primary hip osteoarthritis and no osteoporosis as confirmed by dual X-ray absorptiometry scanning. Patients were followed with radiostereometry for evaluation of stem migration (primary endpoint), evaluation of cement quality, and Oxford Hip Score. Measurements were taken preoperatively, and at three, 12, and 24 months and a minimum five-year follow-up.Aims
Methods
Although the Fitmore Hip Stem has been on the market for almost 15 years, it is still not well documented in randomized controlled trials. This study compares the Fitmore stem with the CementLeSs (CLS) in several different clinical and radiological aspects. The hypothesis is that there will be no difference in outcome between stems. In total, 44 patients with bilateral hip osteoarthritis were recruited from the outpatient clinic at a single tertiary orthopaedic centre. The patients were operated with bilateral one-stage total hip arthroplasty. The most painful hip was randomized to either Fitmore or CLS femoral component; the second hip was operated with the femoral component not used on the first side. Patients were evaluated at three and six months and at one, two, and five years postoperatively with patient-reported outcome measures, radiostereometric analysis, dual-energy X-ray absorptiometry, and conventional radiography. A total of 39 patients attended the follow-up visit at two years (primary outcome) and 35 patients at five years. The primary outcome was which hip the patient considered to have the best function at two years.Aims
Methods
The aim of this study was to compare a bicruciate-retaining (BCR) total knee arthroplasty (TKA) with a posterior cruciate-retaining (CR) TKA design in terms of kinematics, measured using fluoroscopy and stability as micromotion using radiostereometric analysis (RSA). A total of 40 patients with end-stage osteoarthritis were included in this randomized controlled trial. All patients performed a step-up and lunge task in front of a monoplane fluoroscope one year postoperatively. Femorotibial contact point (CP) locations were determined at every flexion angle and compared between the groups. RSA images were taken at baseline, six weeks, three, six, 12, and 24 months postoperatively. Clinical and functional outcomes were compared postoperatively for two years.Aims
Methods
The main advantage of 3D-printed, off-the-shelf acetabular implants is the potential to promote enhanced bony fixation due to their controllable porous structure. In this study we investigated the extent of osseointegration in retrieved 3D-printed acetabular implants. We compared two groups, one made via 3D-printing (n = 7) and the other using conventional techniques (n = 7). We collected implant details, type of surgery and removal technique, patient demographics, and clinical history. Bone integration was assessed by macroscopic visual analysis, followed by sectioning to allow undecalcified histology on eight sections (~200 µm) for each implant. The outcome measures considered were area of bone attachment (%), extent of bone ingrowth (%), bone-implant contact (%), and depth of ingrowth (%), and these were quantified using a line-intercept method.Aims
Methods
Femoral bone preparation using compaction technique has been shown to preserve bone and improve implant fixation in animal models. No long-term clinical outcomes are available. There are no significant long-term differences between compaction and broaching techniques for primary total hip arthroplasty (THA) in terms of migration, clinical, and radiological outcomes. A total of 28 patients received one-stage bilateral primary THA with cementless femoral stems (56 hips). They were randomized to compaction on one femur and broaching on the contralateral femur. Overall, 13 patients were lost to the ten-year follow-up leaving 30 hips to be evaluated in terms of stem migration (using radiostereometry), radiological changes, Harris Hip Score, Oxford Hip Score, and complications.Aims
Methods
Highly polished stems with force-closed design have shown satisfactory clinical results despite being related to relatively high early migration. It has been suggested that the minimal thickness of cement mantles surrounding the femoral stem should be 2 mm to 4 mm to avoid aseptic loosening. The line-to-line cementing technique of the femoral stem, designed to achieve stem press-fit, challenges this opinion. We compared the migration of a highly polished stem with force-closed design by standard and line-to-line cementing to investigate whether differences in early migration of the stems occur in a clinical study. In this single-blind, randomized controlled, clinical radiostereometric analysis (RSA) study, the migration pattern of the cemented Corail hip stem was compared between line-to-line and standard cementing in 48 arthroplasties. The primary outcome measure was femoral stem migration in terms of rotation and translation around and along with the X-, Y-, and Z- axes measured using model-based RSA at three, 12, and 24 months. A linear mixed-effects model was used for statistical analysis.Aims
Methods
Medial pivot (MP) total knee arthroplasties (TKAs) were designed to mimic native knee kinematics with their deep medial congruent fitting of the tibia to the femur almost like a ball-on-socket, and a flat lateral part. GMK Sphere is a novel MP implant. Our primary aim was to study the migration pattern of the tibial tray of this TKA. A total of 31 patients were recruited to this single-group radiostereometric analysis (RSA) study and received a medial pivot GMK Sphere TKA. The distributions of male patients versus female patients and right versus left knees were 21:10 and 17:14, respectively. Mean BMI was 29 kg/m2 (95% confidence interval (CI) 27 to 30) and mean age at surgery was 63 years (95% CI 61 to 66). Maximum total point motions (MTPMs), medial, proximal, and anterior translations and transversal, internal, and varus rotations were calculated at three, 12, and 24 months. Patient-reported outcome measure data were also retrieved.Aims
Methods
To report early (two-year) postoperative findings from a randomized controlled trial (RCT) investigating disease-specific quality of life (QOL), clinical, patient-reported, and radiological outcomes in patients undergoing a total shoulder arthroplasty (TSA) with a second-generation uncemented trabecular metal (TM) glenoid versus a cemented polyethylene glenoid (POLY) component. Five fellowship-trained surgeons from three centres participated. Patients aged between 18 and 79 years with a primary diagnosis of glenohumeral osteoarthritis were screened for eligibility. Patients were randomized intraoperatively to either a TM or POLY glenoid component. Study intervals were: baseline, six weeks, six-, 12-, and 24 months postoperatively. The primary outcome was the Western Ontario Osteoarthritis Shoulder QOL score. Radiological images were reviewed for metal debris. Mixed effects repeated measures analysis of variance for within and between group comparisons were performed.Aims
Methods
To compare the in vivo long-term fixation achieved by two acetabular components with different porous ingrowth surfaces using radiostereometric analysis (RSA). This was a minimum ten-year follow-up of a prospective randomized trial of 62 hips with two different porous ingrowth acetabular components. RSA exams had previously been acquired through two years of follow-up. Patients returned for RSA examination at a minimum of ten years. In addition, radiological appearance of these acetabular components was analyzed, and patient-reported outcome measures (PROMs) obtained.Aims
Methods
The most frequent indication for revision surgery in total hip arthroplasty (THA) is aseptic loosening. Aseptic loosening is associated with polyethylene liner wear, and wear may be reduced by using vitamin E-doped liners. The primary objective of this study was to compare proximal femoral head penetration into the liner between a) two cross-linked polyethylene (XLPE) liners (vitamin E-doped (vE-PE)) versus standard XLPE liners, and b) two modular femoral head diameters (32 mm and 36 mm). Patients scheduled for a THA were randomized to receive a vE-PE or XLPE liner with a 32 mm or 36 mm metal head (four intervention groups in a 2 × 2 factorial design). Head penetration and acetabular component migration were measured using radiostereometric analysis at baseline, three, 12, 24, and 60 months postoperatively. The Harris Hip Score, University of California, Los Angeles (UCLA) Activity Score, EuroQol five-dimension questionnaire (EQ-5D), and 36-Item Short-Form Health Survey questionnaire (SF-36) were assessed at baseline, three, 12, 36, and 60 months.Aims
Methods
Various surgical techniques have been described for total hip arthroplasty (THA) in patients with Crowe type III dislocated hips, who have a large acetabular bone defect. The aim of this study was to evaluate the long-term clinical results of patients in whom anatomical reconstruction of the acetabulum was performed using a cemented acetabular component and autologous bone graft from the femoral neck. A total of 22 patients with Crowe type III dislocated hips underwent 28 THAs using bone graft from the femoral neck between 1979 and 2000. A Charnley cemented acetabular component was placed at the level of the true acetabulum after preparation with bone grafting. All patients were female with a mean age at the time of surgery of 54 years (35 to 68). A total of 18 patients (21 THAs) were followed for a mean of 27.2 years (20 to 33) after the operation.Aims
Methods
Metaphyseal tritanium cones can be used to manage the tibial bone loss commonly encountered at revision total knee arthroplasty (rTKA). Tibial stems provide additional fixation and are generally used in combination with cones. The aim of this study was to examine the role of the stems in the overall stability of tibial implants when metaphyseal cones are used for rTKA. This computational study investigates whether stems are required to augment metaphyseal cones at rTKA. Three cemented stem scenarios (no stem, 50 mm stem, and 100 mm stem) were investigated with 10 mm-deep uncontained posterior and medial tibial defects using four loading scenarios designed to mimic activities of daily living.Aims
Methods
The primary objective of this study was to compare migration of the cemented ATTUNE fixed bearing cruciate retaining tibial component with the cemented Press-Fit Condylar (PFC)-sigma fixed bearing cruciate retaining tibial component. The secondary objectives included comparing clinical and radiological outcomes and Patient Reported Outcome Measures (PROMs). A single blinded randomized, non-inferiority study was conducted including 74 patients. Radiostereometry examinations were made after weight bearing, but before hospital discharge, and at three, six, 12, and 24 months postoperatively. PROMS were collected preoperatively and at three, six, 12, and 24 months postoperatively. Radiographs for measuring radiolucencies were collected at two weeks and two years postoperatively.Aims
Methods
In order to address acetabular defects, porous metal revision acetabular components and augments have been developed, which require fixation to each other. The fixation technique that results in the smallest relative movement between the components, as well as its influence on the primary stability with the host bone, have not previously been determined. A total of 18 composite hemipelvises with a Paprosky IIB defect were implanted using a porous titanium 56 mm multihole acetabular component and 1 cm augment. Each acetabular component and augment was affixed to the bone using two screws, while the method of fixation between the acetabular component and augment varied for the three groups of six hemipelvises: group S, screw fixation only; group SC, screw plus cement fixation; group C, cement fixation only. The implanted hemipelvises were cyclically loaded to three different loading maxima (0.5 kN, 0.9 kN, and 1.8 kN).Objectives
Methods
The aim of this study was to determine the polyethylene wear rate of Phase 3 Oxford Unicompartmental Knee Replacement bearings and to investigate the effects of resin type and manufacturing process. A total of 63 patients with at least ten years’ follow-up with three bearing types (1900 resin machined, 1050 resin machined, and 1050 resin moulded) were recruited. Patients underwent full weight-bearing model-based radiostereometric analysis to determine the bearing thickness. The linear wear rate was estimated from the change in thickness divided by the duration of implantation.Objectives
Methods
Lengthening osteotomies of the calcaneus in children are in general
grafted with bone from the iliac crest. Artificial bone grafts have
been introduced, however, their structural and clinical durability
has not been documented. Radiostereometric analysis (RSA) is a very
accurate and precise method for measurements of rigid body movements including
the evaluation of joint implant and fracture stability, however,
RSA has not previously been used in clinical studies of calcaneal
osteotomies. We assessed the precision of RSA as a measurement tool
in a lateral calcaneal lengthening osteotomy (LCLO). LCLO was performed in six fixed adult cadaver feet. Tantalum
markers were inserted on each side of the osteotomy and in the cuboideum.
Lengthening was done with a plexiglas wedge. A total of 24 radiological
double examinations were obtained. Two feet were excluded due to
loose and poorly dispersed markers. Precision was assessed as systematic
bias and 95% repeatability limits.Objectives
Methods
The December 2015 Spine Roundup360 looks at: Ketamine in scoliosis surgery; Teriparatide in osteoporotic spinal fractures; Trabecular metal in the spine?; Revision surgery a SPORTing chance?; The course of degenerative lumbar spondylolisthesis; Hip or lumbar spine: a common conundrum
The April 2014 Knee Roundup360 looks at: mobile compression as good as chemical thromboprophylaxis; patellar injury with MIS knee surgery; tibial plateau fracture results not as good as we thought; back and knee pain; metaphyseal sleeves may be the answer in revision knee replacement; oral tranexamic acid; gentamycin alone in antibiotic spacers; and whether the jury is still out on unloader braces.
Many aspects of total knee arthroplasty have
changed since its inception. Modern prosthetic design, better fixation techniques,
improved polyethylene wear characteristics and rehabilitation, have
all contributed to a large change in revision rates. Arthroplasty
patients now expect longevity of their prostheses and demand functional
improvement to match. This has led to a re-examination of the long-held
belief that mechanical alignment is instrumental to a successful
outcome and a focus on restoring healthy joint kinematics. A combination
of kinematic restoration and uncemented, adaptable fixation may
hold the key to future advances. Cite this article:
To quantify and compare peri-acetabular bone mineral density
(BMD) between a monoblock acetabular component using a metal-on-metal
(MoM) bearing and a modular titanium shell with a polyethylene (PE)
insert. The secondary outcome was to measure patient-reported clinical
function. A total of 50 patients (25 per group) were randomised to MoM
or metal-on-polyethlene (MoP). There were 27 women (11 MoM) and
23 men (14 MoM) with a mean age of 61.6 years (47.7 to 73.2). Measurements
of peri-prosthetic acetabular and contralateral hip (covariate)
BMD were performed at baseline and at one and two years’ follow-up.
The Western Ontario and McMaster Universities osteoarthritis index
(WOMAC), University of California, Los Angeles (UCLA) activity score,
Harris hip score, and RAND-36 were also completed at these intervals.Objectives
Methods
Periprosthetic joint infection (PJI) is one of
the most feared and challenging complications following total knee arthroplasty.
We provide a detailed description of our current understanding regarding
the management of PJI of the knee, including diagnostic aids,
pre-operative planning, surgical treatment, and outcome. Cite this article:
The objective of this study was to compare the early migration
characteristics and functional outcome of the Triathlon cemented
knee prosthesis with its predecessor, the Duracon cemented knee
prosthesis (both Stryker). A total 60 patients were prospectively randomised and tibial
component migration was measured by radiostereometric analysis (RSA)
at three months, one year and two years; clinical outcome was measured
by the American Knee Society score and the Knee Osteoarthritis and
Injury Outcome Score.Objectives
Methods
Numerous complications following total knee replacement (TKR)
relate to the patellofemoral (PF) joint, including pain and patellar
maltracking, yet the options for A total of three knees with end-stage osteoarthritis and three
knees that had undergone TKR at more than one year’s follow-up were
investigated. In each knee, sequential biplane radiological images
were acquired from the sagittal direction (i.e. horizontal X-ray
source and 10° below horizontal) for a sequence of eight flexion
angles. Three-dimensional implant or bone models were matched to
the biplane images to compute the six degrees of freedom of PF tracking
and TF kinematics, and other clinical measures.Objectives
Methods
