Advertisement for orthosearch.org.uk
Results 1 - 20 of 57
Results per page:
Bone & Joint Research
Vol. 10, Issue 12 | Pages 797 - 806
8 Dec 2021
Chevalier Y Matsuura M Krüger S Traxler H Fleege† C Rauschmann M Schilling C

Aims. Anchorage of pedicle screw rod instrumentation in the elderly spine with poor bone quality remains challenging. Our study aims to evaluate how the screw bone anchorage is affected by screw design, bone quality, loading conditions, and cementing techniques. Methods. Micro-finite element (µFE) models were created from micro-CT (μCT) scans of vertebrae implanted with two types of pedicle screws (L: Ennovate and R: S. 4. ). Simulations were conducted for a 10 mm radius region of interest (ROI) around each screw and for a full vertebra (FV) where different cementing scenarios were simulated around the screw tips. Stiffness was calculated in pull-out and anterior bending loads. Results. Experimental pull-out strengths were excellently correlated to the µFE pull-out stiffness of the ROI (R. 2. > 0.87) and FV (R. 2. > 0.84) models. No significant difference due to screw design was observed. Cement augmentation increased pull-out stiffness by up to 94% and 48% for L and R screws, respectively, but only increased bending stiffness by up to 6.9% and 1.5%, respectively. Cementing involving only one screw tip resulted in lower stiffness increases in all tested screw designs and loading cases. The stiffening effect of cement augmentation on pull-out and bending stiffness was strongly and negatively correlated to local bone density around the screw (correlation coefficient (R) = -0.95). Conclusion. This combined experimental, µCT and µFE study showed that regional analyses may be sufficient to predict fixation strength in pull-out and that full analyses could show that cement augmentation around pedicle screws increased fixation stiffness in both pull-out and bending, especially for low-density bone. Cite this article: Bone Joint Res 2021;10(12):797–806


The Bone & Joint Journal
Vol. 98-B, Issue 8 | Pages 1099 - 1105
1 Aug 2016
Weiser L Dreimann M Huber G Sellenschloh K Püschel K Morlock MM Rueger JM Lehmann W

Aims. Loosening of pedicle screws is a major complication of posterior spinal stabilisation, especially in the osteoporotic spine. Our aim was to evaluate the effect of cement augmentation compared with extended dorsal instrumentation on the stability of posterior spinal fixation. Materials and Methods. A total of 12 osteoporotic human cadaveric spines (T11-L3) were randomised by bone mineral density into two groups and instrumented with pedicle screws: group I (SHORT) separated T12 or L2 and group II (EXTENDED) specimen consisting of T11/12 to L2/3. Screws were augmented with cement unilaterally in each vertebra. Fatigue testing was performed using a cranial-caudal sinusoidal, cyclic (1.0 Hz) load with stepwise increasing peak force. Results. Augmentation showed no significant increase in the mean cycles to failure and fatigue force (SHORT p = 0.067; EXTENDED p = 0.239). Extending the instrumentation resulted in a significantly increased number of cycles to failure and a significantly higher fatigue force compared with the SHORT instrumentation (EXTENDED non-augmented + 76%, p < 0.001; EXTENDED augmented + 87%, p < 0.001). Conclusion. The stabilising effect of cement augmentation of pedicle screws might not be as beneficial as expected from biomechanical pull-out tests. Lengthening the dorsal instrumentation results in a much higher increase of stability during fatigue testing in the osteoporotic spine compared with cement augmentation. Cite this article: Bone Joint J 2016;98-B:1099–1105


Bone & Joint Research
Vol. 9, Issue 9 | Pages 534 - 542
1 Sep 2020
Varga P Inzana JA Fletcher JWA Hofmann-Fliri L Runer A Südkamp NP Windolf M

Aims. Fixation of osteoporotic proximal humerus fractures remains challenging even with state-of-the-art locking plates. Despite the demonstrated biomechanical benefit of screw tip augmentation with bone cement, the clinical findings have remained unclear, potentially as the optimal augmentation combinations are unknown. The aim of this study was to systematically evaluate the biomechanical benefits of the augmentation options in a humeral locking plate using finite element analysis (FEA). Methods. A total of 64 cement augmentation configurations were analyzed using six screws of a locking plate to virtually fix unstable three-part fractures in 24 low-density proximal humerus models under three physiological loading cases (4,608 simulations). The biomechanical benefit of augmentation was evaluated through an established FEA methodology using the average peri-screw bone strain as a validated predictor of cyclic cut-out failure. Results. The biomechanical benefit was already significant with a single cemented screw and increased with the number of augmented screws, but the configuration was highly influential. The best two-screw (mean 23%, SD 3% reduction) and the worst four-screw (mean 22%, SD 5%) combinations performed similarly. The largest benefits were achieved with augmenting screws purchasing into the calcar and having posteriorly located tips. Local bone mineral density was not directly related to the improvement. Conclusion. The number and configuration of cemented screws strongly determined how augmentation can alleviate the predicted risk of cut-out failure. Screws purchasing in the calcar and posterior humeral head regions may be prioritized. Although requiring clinical corroborations, these findings may explain the controversial results of previous clinical studies not controlling the choices of screw augmentation


The Bone & Joint Journal
Vol. 106-B, Issue 7 | Pages 646 - 655
1 Jul 2024
Longo UG Gulotta LV De Salvatore S Lalli A Bandini B Giannarelli D Denaro V

Aims. Proximal humeral fractures are the third most common fracture among the elderly. Complications associated with fixation include screw perforation, varus collapse, and avascular necrosis of the humeral head. To address these challenges, various augmentation techniques to increase medial column support have been developed. There are currently no recent studies that definitively establish the superiority of augmented fixation over non-augmented implants in the surgical treatment of proximal humeral fractures. The aim of this systematic review and meta-analysis was to compare the outcomes of patients who underwent locking-plate fixation with cement augmentation or bone-graft augmentation versus those who underwent locking-plate fixation without augmentation for proximal humeral fractures. Methods. The search was carried out according to the Preferred Reporting Items for Systematic Reviews and Meta-analyses guidelines. Articles involving patients with complex proximal humeral fractures treated using open reduction with locking-plate fixation, with or without augmentation, were considered. A meta-analysis of comparative studies comparing locking-plate fixation with cement augmentation or with bone-graft augmentation versus locking-plate fixation without augmentation was performed. Results. A total of 19 studies were included in the qualitative synthesis, and six comparative studies were included in the meta-analysis. Overall, 120 patients received locking-plate fixation with bone-graft augmentation, 179 patients received locking-plate fixation with cement augmentation, and 336 patients received locking-plate fixation without augmentation. No statistically relevant differences between the augmented and non-augmented cohorts were found in terms of the Disabilities of the Arm, Shoulder and Hand questionnaire score and Constant-Murley Score. The cement-augmented group had a significantly lower rate of complications compared to the non-augmented group. Conclusion. While locking-plate fixation with cement augmentation appears to produce a lower complication rate compared to locking-plate fixation alone, functional outcomes seem comparable between augmented and non-augmented techniques. Cite this article: Bone Joint J 2024;106-B(7):646–655


The Bone & Joint Journal
Vol. 100-B, Issue 4 | Pages 516 - 521
1 Apr 2018
Qian L Jiang C Sun P Xu D Wang Y Fu M Zhong S Ouyang J

Aims. The aim of this study was to compare the peak pull-out force (PPF) of pedicle-lengthening screws (PLS) and traditional pedicle screws (TPS) using instant and cyclic fatigue testing. Materials and Methods. A total of 60 lumbar vertebrae were divided into six groups: PLS submitted to instant pull-out and fatigue-resistance testing (groups A1 and A2, respectively), TPS submitted to instant pull-out and fatigue-resistance testing (groups B1 and B2, respectively) and PLS augmented with 2 ml polymethylmethacrylate, submitted to instant pull-out and fatigue-resistance testing (groups C1 and C2, respectively). The PPF and normalized PPF (PPFn) for bone mineral density (BMD) were compared within and between all groups. Results. In all groups, BMD was significantly correlated with PPF (r = 0.83, p < 0.001). The PPFn in A1 was significantly less than in B1 (p = 0.006) and C1 (p = 0.002). The PPFn of A2 was significantly less than in B2 (p < 0.001) and C2 (p < 0.001). The PPFn in A1, B1, and C1 was significantly greater than in A2 (p = 0.002), B2 (p = 0.027), and C2 (p = 0.003). There were no significant differences in PPFn between B1 and C1, or between B2 and C2. Conclusion. Pedicle lengthening screws with cement augmentation can provide the same fixation stability as traditional pedicle screws and may be a viable clinical option. Cite this article: Bone Joint J 2018;100-B:516–21


The Journal of Bone & Joint Surgery British Volume
Vol. 91-B, Issue 8 | Pages 1078 - 1082
1 Aug 2009
Kang HG Roh YW Kim HS

We have developed a hollow perforated cannulated screw. One or more of these was implanted percutaneously in 11 patients with an osteolytic metastasis in the femoral neck and multiple metastases elsewhere. They were supplemented by one or two additional standard 6.5 mm cannulated screws in nine patients. Polymethylmethacrylate bone cement was injected through the screw into the neck of the femur using small syringes, as in vertebroplasty. The mean amount of cement injected was 23.2 ml (17 to 30). Radiotherapy was started on the fourth post-operative day and chemotherapy, on average, was resumed a day later.

Good structural stability and satisfactory relief from pain were achieved in all the patients. This technique may be useful in the palliation of metastases in the femoral neck.


The Journal of Bone & Joint Surgery British Volume
Vol. 71-B, Issue 4 | Pages 702 - 702
1 Aug 1989
Kay P


The Bone & Joint Journal
Vol. 95-B, Issue 10 | Pages 1406 - 1409
1 Oct 2013
Wähnert D Lange JH Schulze M Gehweiler D Kösters C Raschke MJ

The augmentation of fixation with bone cement is increasingly being used in the treatment of severe osteoporotic fractures. We investigated the influence of bone quality on the mechanics of augmentation of plate fixation in a distal femoral fracture model (AO 33 A3 type). Eight osteoporotic and eight non-osteoporotic femoral models were randomly assigned to either an augmented or a non-augmented group. Fixation was performed using a locking compression plate. In the augmented group additionally 1 ml of bone cement was injected into the screw hole before insertion of the screw. Biomechanical testing was performed in axial sinusoidal loading. Augmentation significantly reduced the cut-out distance in the osteoporotic models by about 67% (non-augmented mean 0.30 mm (sd 0.08) vs augmented 0.13 mm (sd 0.06); p = 0.017). There was no statistical reduction in this distance following augmentation in the non-osteoporotic models (non-augmented mean 0.15 mm (sd 0.02) vs augmented 0.15 mm (sd 0.07); p = 0.915). In the osteoporotic models, augmentation significantly increased stability (p = 0.017).

Cite this article: Bone Joint J 2013;95-B:1406–9.


The Bone & Joint Journal
Vol. 99-B, Issue 7 | Pages 973 - 978
1 Jul 2017
Gupta S Kafchinski LA Gundle KR Saidi K Griffin AM Wunder JS Ferguson PC

Aims

Intercalary allografts following resection of a primary diaphyseal tumour have high rates of complications and failures. At our institution intercalary allografts are augmented with intramedullary cement and fixed using compression plating. Our aim was to evaluate their long-term outcomes.

Patients and Methods

A total of 46 patients underwent reconstruction with an intercalary allograft between 1989 and 2014. The patients had a mean age of 32.8 years (14 to 77). The most common diagnoses were osteosarcoma (n = 16) and chondrosarcoma (n = 9). The location of the tumours was in the femur in 21, the tibia in 16 and the humerus in nine. Function was assessed using the Musculoskeletal Tumor Society (MSTS) scoring system and the Toronto Extremity Salvage Score (TESS). The survival of the graft and the overall survival were assessed using the Kaplan-Meier method.


The Bone & Joint Journal
Vol. 98-B, Issue 5 | Pages 703 - 709
1 May 2016
Kim Y Kang HG Kim JH Kim S Lin PP Kim HS

Aims. The purpose of the study was to investigate whether closed intramedullary (IM) nailing with percutaneous cement augmentation is better than conventional closed nailing at relieving pain and suppressing tumours in patients with metastases of the femur and humerus. Patients and Methods. A total of 43 patients (27 men, 16 women, mean age 63.7 years, standard deviation (. sd. ) 12.2; 21 to 84) underwent closed IM nailing with cement augmentation for long bone metastases. A further 27 patients, who underwent conventional closed IM nailing, served as controls. Pain was assessed using a visual analogue scale (VAS) score pre-operatively (pre-operative VAS), one week post-operatively (immediate post-operative VAS), and at six weeks post-operatively (follow-up post-operative VAS). Progression of the tumour was evaluated in subgroups of patients using F-18-fludeoxyglucose (F-18-FDG) positron emission tomography (PET)/computed tomography (CT) and/or bone scintigraphy (BS), at a mean of 8.8 and 7.2 months post-operatively, respectively. Results. The mean pain scores of patients who underwent closed nailing with cement augmentation were significantly lower than those of the control patients post-operatively (immediate post-operative VAS: 3.8, . sd. 0.9 versus 6.0, . sd. 0.9; follow-up post-operative VAS: 3.3, . sd. 2.5 versus 6.6, . sd. 2.2; all p < 0.001). The progression of the metastasis was suppressed in 50% (10/20) of patients who underwent closed nailing with augmentation, but in only 8% (1/13) of those in the control group. Conclusion. Percutaneous cement augmentation of closed IM nailing improves the relief of pain and limits the progression of the tumour in patients with metastases to the long bones. Take home message: Percutaneous cement augmentation while performing closed IM nailing has some advantages for long bone metastases. Cite this article: Bone Joint J 2016;98-B:703–9


Bone & Joint Research
Vol. 5, Issue 9 | Pages 419 - 426
1 Sep 2016
Leichtle CI Lorenz A Rothstock S Happel J Walter F Shiozawa T Leichtle UG

Objectives. Cement augmentation of pedicle screws could be used to improve screw stability, especially in osteoporotic vertebrae. However, little is known concerning the influence of different screw types and amount of cement applied. Therefore, the aim of this biomechanical in vitro study was to evaluate the effect of cement augmentation on the screw pull-out force in osteoporotic vertebrae, comparing different pedicle screws (solid and fenestrated) and cement volumes (0 mL, 1 mL or 3 mL). Materials and Methods. A total of 54 osteoporotic human cadaver thoracic and lumbar vertebrae were instrumented with pedicle screws (uncemented, solid cemented or fenestrated cemented) and augmented with high-viscosity PMMA cement (0 mL, 1 mL or 3 mL). The insertion torque and bone mineral density were determined. Radiographs and CT scans were undertaken to evaluate cement distribution and cement leakage. Pull-out testing was performed with a material testing machine to measure failure load and stiffness. The paired t-test was used to compare the two screws within each vertebra. Results. Mean failure load was significantly greater for fenestrated cemented screws (+622 N; p ⩽ 0.001) and solid cemented screws (+460 N; p ⩽ 0.001) than for uncemented screws. There was no significant difference between the solid and fenestrated cemented screws (p = 0.5). In the lower thoracic vertebrae, 1 mL cement was enough to significantly increase failure load, while 3 mL led to further significant improvement in the upper thoracic, lower thoracic and lumbar regions. Conclusion. Conventional, solid pedicle screws augmented with high-viscosity cement provided comparable screw stability in pull-out testing to that of sophisticated and more expensive fenestrated screws. In terms of cement volume, we recommend the use of at least 1 mL in the thoracic and 3 mL in the lumbar spine. Cite this article: C. I. Leichtle, A. Lorenz, S. Rothstock, J. Happel, F. Walter, T. Shiozawa, U. G. Leichtle. Pull-out strength of cemented solid versus fenestrated pedicle screws in osteoporotic vertebrae. Bone Joint Res 2016;5:419–426


Bone & Joint 360
Vol. 3, Issue 1 | Pages 32 - 34
1 Feb 2014

The February 2014 Oncology Roundup. 360 . looks at: suspicious lesions; limb salvage in pelvic sarcomas; does infection affect oncological survival?; cancer patient pathways; radiological arthritis with cement augmentation in GCT; and post-chemotherapy increase in tumour volume as a predictor of poor prognosis


Bone & Joint Research
Vol. 7, Issue 6 | Pages 422 - 429
1 Jun 2018
Acklin YP Zderic I Inzana JA Grechenig S Schwyn R Richards RG Gueorguiev B

Aims. Plating displaced proximal humeral fractures is associated with a high rate of screw perforation. Dynamization of the proximal screws might prevent these complications. The aim of this study was to develop and evaluate a new gliding screw concept for plating proximal humeral fractures biomechanically. Methods. Eight pairs of three-part humeral fractures were randomly assigned for pairwise instrumentation using either a prototype gliding plate or a standard PHILOS plate, and four pairs were fixed using the gliding plate with bone cement augmentation of its proximal screws. The specimens were cyclically tested under progressively increasing loading until perforation of a screw. Telescoping of a screw, varus tilting and screw migration were recorded using optical motion tracking. Results. Mean initial stiffness (N/mm) was 581.3 (. sd. 239.7) for the gliding plate, 631.5 (. sd. 160.0) for the PHILOS and 440.2 (. sd. 97.6) for the gliding augmented plate without significant differences between the groups (p = 0.11). Mean varus tilting (°) after 7500 cycles was comparable between the gliding plate (2.6; . sd. 1.9), PHILOS (1.2; . sd. 0.6) and gliding augmented plate (1.7; . sd. 0.9) (p = 0.10). Similarly, mean screw migration(mm) after 7500 cycles was similar between the gliding plate (3.02; . sd. 2.85), PHILOS (1.30; . sd. 0.44) and gliding augmented plate (2.83; . sd. 1.18) (p = 0.13). Mean number of cycles until failure with 5° varus tilting were 12702 (. sd. 3687) for the gliding plate, 13948 (. sd. 1295) for PHILOS and 13189 (. sd. 2647) for the gliding augmented plate without significant differences between the groups (p = 0.66). Conclusion. Biomechanically, plate fixation using a new gliding screw technology did not show considerable advantages in comparison with fixation using a standard PHILOS plate. Based on the finding of telescoping of screws, however, it may represent a valid approach for further investigations into how to avoid the cut-out of screws. Cite this article: Y. P. Acklin, I. Zderic, J. A. Inzana, S. Grechenig, R. Schwyn, R. G. Richards, B. Gueorguiev. Biomechanical evaluation of a new gliding screw concept for the fixation of proximal humeral fractures. Bone Joint Res 2018;7:422–429. DOI: 10.1302/2046-3758.76.BJR-2017-0356.R1


The Journal of Bone & Joint Surgery British Volume
Vol. 77-B, Issue 2 | Pages 277 - 283
1 Mar 1995
Choueka J Koval K Kummer F Crawford G Zuckerman J

We studied the biomechanical behaviour of three sliding fixation devices for trochanteric femoral fractures. These were a titanium alloy sideplate and lag screw, a titanium alloy sideplate and dome plunger with cement augmentation, and a stainless-steel sideplate and lag screw. We used 18 mildly osteoporotic cadaver femora, randomly assigned to one of the three fixation groups. Four displacement and two strain gauges were fixed to each specimen, and each femur was first tested intact (control), then as a two-part fracture and then as a four-part intertrochanteric fracture. A range of physiological loads was applied to determine load-bearing, load-sharing and head displacement. The four-part-fracture specimens were subsequently tested to failure to determine maximum fixation strengths and modes of failure. The dome-plunger group failed at a load 50% higher than that of the stainless-steel lag-screw group (p < 0.05) and at a load 20% higher than that of the titanium-alloy lag-screw group (NS). All 12 lag-screw specimens failed by cut-out through the femoral head or neck, but none of the dome-plunger group showed movement within the femoral head when tested to failure. Strain-gauge analysis showed that the dome plunger produced considerably less strain in the inferior neck and calcar region than either of the lag screws. Inferior displacement of the femoral head was greatest for the dome-plunger group, and was due to sliding of the plunger. The dome plunger with cement augmentation was able to support higher loads and did not fail by cut-out through the femoral head.(ABSTRACT TRUNCATED AT 250 WORDS)


Bone & Joint 360
Vol. 13, Issue 4 | Pages 26 - 29
2 Aug 2024

The August 2024 Shoulder & Elbow Roundup360 looks at: Comparing augmented and nonaugmented locking-plate fixation for proximal humeral fractures in the elderly; Elevated five-year mortality following shoulder arthroplasty for fracture; Total intravenous anaesthesia with propofol reduces discharge times compared with inhaled general anaesthesia in shoulder arthroscopy: a randomized controlled trial; The influence of obesity on outcomes following arthroscopic rotator cuff repair; Humeral component version has no effect on outcomes following reverse total shoulder arthroplasty: a prospective, double-blinded, randomized controlled trial; What is a meaningful improvement after total shoulder arthroplasty by implant type, preoperative diagnosis, and sex?; The safety of corticosteroid injection prior to shoulder arthroplasty: a systematic review; Mortality and subsequent fractures of patients with olecranon fractures compared to other upper limb osteoporotic fractures.


The Bone & Joint Journal
Vol. 104-B, Issue 2 | Pages 297 - 301
1 Feb 2022
Jamshidi K Bagherifard A Mohaghegh MR Mirzaei A

Aims

Giant cell tumours (GCTs) of the proximal femur are rare, and there is no consensus about the best method of filling the defect left by curettage. In this study, we compared the outcome of using a fibular strut allograft and bone cement to reconstruct the bone defect after extended curettage of a GCT of the proximal femur.

Methods

In a retrospective study, we reviewed 26 patients with a GCT of the proximal femur in whom the bone defect had been filled with either a fibular strut allograft (n = 12) or bone cement (n = 14). Their demographic details and oncological and nononcological complications were retrieved from their medical records. Limb function was assessed using the Musculoskeletal Tumor Society (MSTS) score.


Bone & Joint 360
Vol. 12, Issue 4 | Pages 16 - 20
1 Aug 2023

The August 2023 Knee Roundup360 looks at: Curettage and cementation of giant cell tumour of bone: is arthritis a given?; Anterior knee pain following total knee arthroplasty: does the patellar cement-bone interface affect postoperative anterior knee pain?; Nickel allergy and total knee arthroplasty; The use of artificial intelligence for the prediction of periprosthetic joint infection following aseptic revision total knee arthroplasty; Ambulatory unicompartmental knee arthroplasty: development of a patient selection tool using machine learning; Femoral asymmetry: a missing piece in knee alignment; Needle arthroscopy – a benefit to patients in the outpatient setting; Can lateral unicompartmental knees be done in a day-case setting?


Bone & Joint Research
Vol. 13, Issue 6 | Pages 306 - 314
19 Jun 2024
Wu B Su J Zhang Z Zeng J Fang X Li W Zhang W Huang Z

Aims

To explore the clinical efficacy of using two different types of articulating spacers in two-stage revision for chronic knee periprosthetic joint infection (kPJI).

Methods

A retrospective cohort study of 50 chronic kPJI patients treated with two types of articulating spacers between January 2014 and March 2022 was conducted. The clinical outcomes and functional status of the different articulating spacers were compared. Overall, 17 patients were treated with prosthetic spacers (prosthetic group (PG)), and 33 patients were treated with cement spacers (cement group (CG)). The CG had a longer mean follow-up period (46.67 months (SD 26.61)) than the PG (24.82 months (SD 16.46); p = 0.001).


Bone & Joint Open
Vol. 5, Issue 1 | Pages 37 - 45
19 Jan 2024
Alm CE Karlsten A Madsen JE Nordsletten L Brattgjerd JE Pripp AH Frihagen F Röhrl SM

Aims

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.

Methods

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.


The Bone & Joint Journal
Vol. 104-B, Issue 8 | Pages 997 - 1008
1 Aug 2022

Aims

The aim of this study was to describe the management and associated outcomes of patients sustaining a femoral hip periprosthetic fracture (PPF) in the UK population.

Methods

This was a multicentre retrospective cohort study including adult patients who presented to 27 NHS hospitals with 539 new PPFs between 1 January 2018 and 31 December 2018. Data collected included: management strategy (operative and nonoperative), length of stay, discharge destination, and details of post-treatment outcomes (reoperation, readmission, and 30-day and 12-month mortality). Descriptive analysis by fracture type was performed, and predictors of PPF management and outcomes were assessed using mixed-effects logistic regression.