Advertisement for orthosearch.org.uk
Results 1 - 20 of 65
Results per page:
The Bone & Joint Journal
Vol. 102-B, Issue 8 | Pages 1016 - 1024
1 Aug 2020
Hasan S van Hamersveld KT Marang-van de Mheen PJ Kaptein BL Nelissen RGHH Toksvig-Larsen S

Aims. Although bone cement is the primary mode of fixation in total knee arthroplasty (TKA), cementless fixation is gaining interest as it has the potential of achieving lasting biological fixation. By 3D printing an implant, highly porous structures can be manufactured, promoting osseointegration into the implant to prevent aseptic loosening. This study compares the migration of cementless, 3D-printed TKA to cemented TKA of a similar design up to two years of follow-up using radiostereometric analysis (RSA) known for its ability to predict aseptic loosening. Methods. A total of 72 patients were randomized to either cementless 3D-printed or a cemented cruciate retaining TKA. RSA and clinical scores were evaluated at baseline and postoperatively at three, 12, and 24 months. A mixed model was used to analyze the repeated measurements. Results. The mean maximum total point motion (MTPM) at three, 12, and 24 months was 0.33 mm (95% confidence interval (CI) 0.25 to 0.42), 0.42 mm (95% CI 0.33 to 0.51), and 0.47 mm (95% CI 0.38 to 0.57) respectively in the cemented group, versus 0.52 mm (95% CI 0.43 to 0.63), 0.62 mm (95% CI 0.52 to 0.73), and 0.64 mm (95% CI 0.53 to 0.75) in the cementless group (p = 0.003). However, using three months as baseline, no difference in mean migration between groups was found (p = 0.497). Three implants in the cemented group showed a > 0.2 mm increase in MTPM between one and two years of follow-up. In the cementless group, one implant was revised due to pain and progressive migration, and one patient had a liner-exchange due to a deep infection. Conclusion. The cementless TKA migrated more than the cemented TKA in the first two-year period. This difference was mainly due to a higher initial migration of the cementless TKA in the first three postoperative months after which stabilization was observed in all but one malaligned and early revised TKA. Whether the biological fixation of the cementless implants will result in an increased long-term survivorship requires a longer follow-up. Cite this article: Bone Joint J 2020;102-B(8):1016–1024


The Bone & Joint Journal
Vol. 101-B, Issue 7_Supple_C | Pages 40 - 47
1 Jul 2019
Sporer S MacLean L Burger A Moric M

Aims. Our intention was to investigate if the highly porous biological fixation surfaces of a new 3D-printed total knee arthroplasty (TKA) achieved adequate fixation of the tibial and patellar components to the underlying bone. Patients and Methods. A total of 29 patients undergoing primary TKA consented to participate in this prospective cohort study. All patients received a highly porous tibial baseplate and metal-backed patella. Patient-reported outcomes measures were recorded and implant migration was assessed using radiostereometric analysis. Results. Patient function significantly improved by three months postoperatively (p < 0.001). Mean difference in maximum total point motion between 12 and 24 months was 0.021 mm (-0.265 to 0.572) for the tibial implant and 0.089 mm (-0.337 to 0.758) for the patellar implant. The rate of tibial and patellar migration was largest over the first six postoperative weeks, with no changes in mean tibia migration occurring after six months, and no changes in mean patellar migration occurring after six weeks. One patellar component showed a rapid rate of migration between 12 and 24 months. Conclusion. Biological fixation appears to occur reliably on the highly porous implant surface of the tibial baseplate and metal-backed patellar component. Rapid migration after 12 months was measured for one patellar component. Further investigation is required to assess the long-term stability of the 3D-printed components and to determine if the high-migrating components achieve fixation. Cite this article: Bone Joint J 2019;101-B(7 Supple C):40–47


The Bone & Joint Journal
Vol. 103-B, Issue 6 Supple A | Pages 32 - 37
1 Jun 2021
Restrepo S Smith EB Hozack WJ

Aims. Cementless total knee arthroplasty (TKA) offers the potential for strong biological fixation compared with cemented TKA where fixation is achieved by the mechanical integration of the cement. Few mid-term results are available for newer cementless TKA designs, which have used additive manufacturing (3D printing). The aim of this study was to present mid-term clinical outcomes and implant survivorship of the cementless Stryker Triathlon Tritanium TKA. Methods. This was a single institution registry review of prospectively gathered data from 341 cementless Triathlon Tritanium TKAs at four to 6.8 years follow-up. Outcomes were determined by comparing pre- and postoperative Knee Injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS JR) scores, and pre- and postoperative 12-item Veterans RAND/Short Form Health Survey (VR/SF-12) scores. Aseptic loosening and revision for any reason were the endpoints which were used to determine survivorship at five years. Results. At mid-term follow-up, the mean KOOS JR score improved significantly from 33.14 (0 t0 85, standard deviation (SD) 21.88) preoperatively to 84.12 (15.94 to 100, SD 20.51) postoperatively (p < 0.001), the mean VR/SF-12 scores improved significantly from physical health (PH), 31.21 (SD 5.32; 23.99 to 56.77) preoperatively to 42.62 (SD 10.72; 19.38 to 56.82) postoperatively (p < 0.001) and the mental health (MH), 38.15 (SD 8.17; 19.06 to 60.75) preoperatively to 55.09 (SD 9.64; 19.06 to 66.98) postoperatively (p < 0.001). A total of 11 revisions were undertaken, with an overall revision rate of 2.94%, including five for periprosthetic joint infection (1.34%), three for loosening (0.80%), two for instability (0.53%), and one for pain (0.27%). The overall survivorship was 97.06% and survivorship for aseptic loosening as the endpoint was 98.40%, with a 99.5% survivorship of the 3D-printed tibial component. Conclusion. This 3D-printed cementless total knee system shows excellent survivorship at mid-term follow-up. This design and the ability to obtain cementless fixation offers promise for excellent long-term durability. Cite this article: Bone Joint J 2021;103-B(6 Supple A):32–37


The Bone & Joint Journal
Vol. 102-B, Issue 6 Supple A | Pages 116 - 122
1 Jun 2020
Bedard NA Cates RA Lewallen DG Sierra RJ Hanssen AD Berry DJ Abdel MP

Aims. Metaphyseal cones with cemented stems are frequently used in revision total knee arthroplasty (TKA). However, if the diaphysis has been previously violated, the resultant sclerotic canal can impair cemented stem fixation, which is vital for bone ingrowth into the cone, and long-term fixation. We report the outcomes of our solution to this problem, in which impaction grafting and a cemented stem in the diaphysis is combined with an uncemented metaphyseal cone, for revision TKA in patients with severely compromised bone. Methods. A metaphyseal cone was combined with diaphyseal impaction grafting and cemented stems for 35 revision TKAs. There were two patients with follow-up of less than two years who were excluded, leaving 33 procedures in 32 patients in the study. The mean age of the patients at the time of revision TKA was 67 years (32 to 87); 20 (60%) were male. Patients had undergone a mean of four (1 to 13) previous knee arthroplasty procedures. The indications for revision were aseptic loosening (80%) and two-stage reimplantation for prosthetic joint infection (PJI; 20%). The mean follow-up was four years (2 to 11). Results. Survival free from revision of the cone/impaction grafting construct due to aseptic loosening was 100% at five years. Survival free from any revision of the construct and free from any reoperation were 92% and 73% at five years, respectively. A total of six patients (six TKAs, 17%) required a further revision, four for infection or wound issues, and two for periprosthetic fracture. Radiologically, one unrevised TKA had evidence of loosening which was asymptomatic. In all unrevised TKAs the impacted diaphyseal bone graft appeared to be incorporated radiologically. Conclusion. When presented with a sclerotic diaphysis and substantial metaphyseal bone loss, this technique combining diaphyseal impaction grafting with a metaphyseal cone provided near universal success in relation to implant fixation. Moreover, radiographs revealed incorporation of the bone graft and biological fixation of the cone. While long-term follow-up will be important, this technique provides an excellent option for the management of complex revision TKAs. Cite this article: Bone Joint J 2020;102-B(6 Supple A):116–122


The Bone & Joint Journal
Vol. 101-B, Issue 10 | Pages 1238 - 1247
1 Oct 2019
Soreide E Denbeigh JM Lewallen EA Thaler R Xu W Berglund L Yao JJ Martinez A Nordsletten L van Wijnen AJ Kakar S

Aims. Options for the treatment of intra-articular ligament injuries are limited, and insufficient ligament reconstruction can cause painful joint instability, loss of function, and progressive development of degenerative arthritis. This study aimed to assess the capability of a biologically enhanced matrix material for ligament reconstruction to withstand tensile forces within the joint and enhance ligament regeneration needed to regain joint function. Materials and Methods. A total of 18 New Zealand rabbits underwent bilateral anterior cruciate ligament reconstruction by autograft, FiberTape, or FiberTape-augmented autograft. Primary outcomes were biomechanical assessment (n = 17), microCT (µCT) assessment (n = 12), histological evaluation (n = 12), and quantitative polymerase chain reaction (qPCR) analysis (n = 6). Results. At eight weeks, FiberTape alone or FiberTape-augmented autograft demonstrated increased biomechanical stability compared with autograft regarding ultimate load to failure (p = 0.035), elongation (p = 0.006), and energy absorption (p = 0.022). FiberTape-grafted samples also demonstrated increased bone mineral density in the bone tunnel (p = 0.039). Histological evaluation showed integration of all grafts in the bone tunnels by new bone formation, and limited signs of inflammation overall. A lack of prolonged inflammation in all samples was confirmed by quantification of inflammation biomarkers. However, no regeneration of ligament-like tissue was observed along the suture tape materials. Except for one autograft failure, no adverse events were detected. Conclusion. Our results indicate that FiberTape increases the biomechanical performance of intra-articular ligament reconstructions in a verified rabbit model at eight weeks. Within this period, FiberTape did not adversely affect bone tunnel healing or invoke a prolonged elevation in inflammation. Cite this article: Bone Joint J 2019;101-B:1238–1247


The Bone & Joint Journal
Vol. 106-B, Issue 9 | Pages 907 - 915
1 Sep 2024
Ross M Zhou Y English M Sharplin P Hirner M

Aims

Knee osteoarthritis (OA) is characterized by a chronic inflammatory process involving multiple cytokine pathways, leading to articular cartilage degeneration. Intra-articular therapies using pharmaceutical or autologous anti-inflammatory factors offer potential non-surgical treatment options. Autologous protein solution (APS) is one such product that uses the patient’s blood to produce a concentrate of cells and anti-inflammatory cytokines. This study evaluated the effect of a specific APS intra-articular injection (nSTRIDE) on patient-reported outcome measures compared to saline in moderate knee OA.

Methods

A parallel, double-blinded, placebo-controlled randomized controlled trial was conducted, where patients with unilateral moderate knee OA (Kellgren-Lawrence grade 2 or 3) received either nSTRIDE or saline (placebo) injection to their symptomatic knee. The primary outcome was the difference in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) total score at 12 months post-intervention. Secondary outcomes included WOMAC component scores, Knee injury and Osteoarthritis Outcome Score (KOOS), and visual analogue scale (VAS) scores at all follow-up timepoints (three, six, and 12 months).


The Bone & Joint Journal
Vol. 105-B, Issue 12 | Pages 1279 - 1285
1 Dec 2023
Baker JF Nadar AC Jouflas AC Smith LS Sachdeva S Yakkanti MR Malkani AL

Aims

The use of cementless total knee arthroplasty (TKA) components has increased during the past decade. The initial design of cementless metal-backed patellar components had shown high failure rates due to many factors. The aim of this study was to evaluate the clinical results of a second-generation cementless, metal-backed patellar component of a modern design.

Methods

This was a retrospective review of 707 primary TKAs in 590 patients from a single institution, using a cementless, metal-backed patellar component with a mean follow-up of 6.9 years (2 to 12). A total of 409 TKAs were performed in 338 females and 298 TKAs in 252 males. The mean age of the patients was 63 years (34 to 87) and their mean BMI was 34.3 kg/m2 (18.8 to 64.5). The patients were chosen to undergo a cementless procedure based on age and preoperative radiological and intraoperative bone quality. Outcome was assessed using the Knee Society knee and function scores and range of motion (ROM), complications, and revisions.


Aims

The aim of this study was to compare the migration of the femoral component, five years postoperatively, between patients with a highly cross-linked polyethylene (HXLPE) insert and those with a conventional polyethylene (PE) insert in an uncemented Triathlon fixed insert cruciate-retaining total knee arthroplasty (TKA). Secondary aims included clinical outcomes and patient-reported outcome measures (PROMs). We have previously reported the migration and outcome of the tibial components in these patients.

Methods

A double-blinded randomized controlled trial was conducted including 96 TKAs. The migration of the femoral component was measured with radiostereometry (RSA) at three and six months and one, two, and five years postoperatively. PROMs were collected preoperatively and at all periods of follow-up.


The Bone & Joint Journal
Vol. 104-B, Issue 9 | Pages 1047 - 1051
1 Sep 2022
Balato G Dall’Anese R Balboni F Ascione T Pezzati P Bartolini G Quercioli M Baldini A

Aims

The diagnosis of periprosthetic joint infection (PJI) continues to present a significant clinical challenge. New biomarkers have been proposed to support clinical decision-making; among them, synovial fluid alpha-defensin has gained interest. Current research methodology suggests reference methods are needed to establish solid evidence for use of the test. This prospective study aims to evaluate the diagnostic accuracy of high-performance liquid chromatography coupled with the mass spectrometry (LC-MS) method to detect alpha-defensin in synovial fluid.

Methods

Between October 2017 and September 2019, we collected synovial fluid samples from patients scheduled to undergo revision surgery for painful total knee arthroplasty (TKA). The International Consensus Meeting criteria were used to classify 33 PJIs and 92 aseptic joints. LC-MS assay was performed to measure alpha-defensin in synovial fluid of all included patients. Sensitivity, specificity, positive predictive value, negative predictive value, and the area under the receiver operating characteristic curve (AUC) were calculated to define the test diagnostic accuracy.


The Bone & Joint Journal
Vol. 104-B, Issue 6 | Pages 663 - 671
1 Jun 2022
Lewis E Merghani K Robertson I Mulford J Prentice B Mathew R Van Winden P Ogden K

Aims

Platelet-rich plasma (PRP) intra-articular injections may provide a simple and minimally invasive treatment for early-stage knee osteoarthritis (OA). This has led to an increase in its adoption as a treatment for knee OA, although there is uncertainty about its efficacy and benefit. We hypothesized that patients with early-stage symptomatic knee OA who receive multiple PRP injections will have better clinical outcomes than those receiving single PRP or placebo injections.

Methods

A double-blinded, randomized placebo-controlled trial was performed with three groups receiving either placebo injections (Normal Saline), one PRP injection followed by two placebo injections, or three PRP injections. Each injection was given one week apart. Outcomes were prospectively collected prior to intervention and then at six weeks, three months, six months, and 12 months post-intervention. Primary outcome measures were Knee Injury and Osteoarthritis Outcome Score (KOOS) and EuroQol five-dimension five-level index (EQ-5D-5L). Secondary outcomes included visual analogue scale for pain and patient subjective assessment of the injections.


The Bone & Joint Journal
Vol. 104-B, Issue 4 | Pages 444 - 451
1 Apr 2022
Laende EK Mills Flemming J Astephen Wilson JL Cantoni E Dunbar MJ

Aims

Thresholds of acceptable early migration of the components in total knee arthroplasty (TKA) have traditionally ignored the effects of patient and implant factors that may influence migration. The aim of this study was to determine which of these factors are associated with overall longitudinal migration of well-fixed tibial components following TKA.

Methods

Radiostereometric analysis (RSA) data over a two-year period were available for 419 successful primary TKAs (267 cemented and 152 uncemented in 257 female and 162 male patients). Longitudinal analysis of data using marginal models was performed to examine the associations of patient factors (age, sex, BMI, smoking status) and implant factors (cemented or uncemented, the size of the implant) with maximum total point motion (MTPM) migration. Analyses were also performed on subgroups based on sex and fixation.


The Bone & Joint Journal
Vol. 98-B, Issue 7 | Pages 867 - 873
1 Jul 2016
Dalury DF

As the number of younger and more active patients treated with total knee arthroplasty (TKA) continues to increase, consideration of better fixation as a means of improving implant longevity is required. Cemented TKA remains the reference standard with the largest body of evidence and the longest follow-up to support its use. However, cementless TKA, may offer the opportunity of a more bone-sparing procedure with long lasting biological fixation to the bone. We undertook a review of the literature examining advances of cementless TKA and the reported results. . Cite this article: Bone Joint J 2016;98-B:867–73


The Bone & Joint Journal
Vol. 104-B, Issue 3 | Pages 376 - 385
1 Mar 2022
Gramlich Y Hofmann L Kress S Ruckes C Kemmerer M Klug A Hoffmann R Kremer M

Aims

This study compared the cobalt and chromium serum ion concentration of patients treated with two different metal-on-metal (MoM) hinged total knee arthroplasty (TKA) systems, as well as a titanium nitride (TiN)-coated variant.

Methods

A total of 63 patients (65 implants) were treated using either a MoM-coated (n = 29) or TiN-coated (n = 7) hinged TKA (GenuX mobile bearing, MUTARS; Implantcast, Germany) versus the BPKS (Brehm, Germany) hinged TKA (n = 27), in which the weight placed on the MoM hinge is diffused through a polyethylene (PE) inlay, reducing the direct load on the MoM hinge. Serum cobalt and chromium ion concentrations were assessed after minimum follow-up of 12 months, as well as functional outcome and quality of life.


The Bone & Joint Journal
Vol. 95-B, Issue 3 | Pages 301 - 304
1 Mar 2013
Brennan SA Devitt BM O’Neill CJ Nicholson P

Focal femoral inlay resurfacing has been developed for the treatment of full-thickness chondral defects of the knee. This technique involves implanting a defect-sized metallic or ceramic cap that is anchored to the subchondral bone through a screw or pin. The use of these experimental caps has been advocated in middle-aged patients who have failed non-operative methods or biological repair techniques and are deemed unsuitable for conventional arthroplasty because of their age. This paper outlines the implant design, surgical technique and biomechanical principles underlying their use. Outcomes following implantation in both animal and human studies are also reviewed. Cite this article: Bone Joint J 2013;95-B:301–4


The Bone & Joint Journal
Vol. 103-B, Issue 11 | Pages 1686 - 1694
1 Nov 2021
Yang H Kwak W Kang SJ Song E Seon J

Aims

To determine the relationship between articular cartilage status and clinical outcomes after medial opening-wedge high tibial osteotomy (MOHTO) for medial compartmental knee osteoarthritis at intermediate follow-up.

Methods

We reviewed 155 patients (155 knees) who underwent MOHTO from January 2008 to December 2016 followed by second-look arthroscopy with a mean 5.3-year follow-up (2.0 to 11.7). Arthroscopic findings were assessed according to the International Cartilage Repair Society (ICRS) Cartilage Repair Assessment (CRA) grading system. Patients were divided into two groups based on the presence of normal or nearly normal quality cartilage in the medial femoral condyle: good (second-look arthroscopic) status (ICRS grade I or II; n = 70), and poor (second-look arthroscopic) status (ICRS grade III or IV; n = 85) groups at the time of second-look arthroscopy. Clinical outcomes were assessed using the International Knee Documentation Committee (IKDC) score, Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), and 36-Item Short Form survey.


The Bone & Joint Journal
Vol. 103-B, Issue 8 | Pages 1373 - 1379
1 Aug 2021
Matar HE Bloch BV Snape SE James PJ

Aims

Single-stage revision total knee arthroplasty (rTKA) is gaining popularity in treating chronic periprosthetic joint infections (PJIs). We have introduced this approach to our clinical practice and sought to evaluate rates of reinfection and re-revision, along with predictors of failure of both single- and two-stage rTKA for chronic PJI.

Methods

A retrospective comparative cohort study of all rTKAs for chronic PJI between 1 April 2003 and 31 December 2018 was undertaken using prospective databases. Patients with acute infections were excluded; rTKAs were classified as single-stage, stage 1, or stage 2 of two-stage revision. The primary outcome measure was failure to eradicate or recurrent infection. Variables evaluated for failure by regression analysis included age, BMI, American Society of Anesthesiologists grade, infecting organisms, and the presence of a sinus. Patient survivorship was also compared between the groups.


The Bone & Joint Journal
Vol. 103-B, Issue 8 | Pages 1358 - 1366
2 Aug 2021
Wei C Quan T Wang KY Gu A Fassihi SC Kahlenberg CA Malahias M Liu J Thakkar S Gonzalez Della Valle A Sculco PK

Aims

This study used an artificial neural network (ANN) model to determine the most important pre- and perioperative variables to predict same-day discharge in patients undergoing total knee arthroplasty (TKA).

Methods

Data for this study were collected from the National Surgery Quality Improvement Program (NSQIP) database from the year 2018. Patients who received a primary, elective, unilateral TKA with a diagnosis of primary osteoarthritis were included. Demographic, preoperative, and intraoperative variables were analyzed. The ANN model was compared to a logistic regression model, which is a conventional machine-learning algorithm. Variables collected from 28,742 patients were analyzed based on their contribution to hospital length of stay.


The Journal of Bone & Joint Surgery British Volume
Vol. 94-B, Issue 1 | Pages 62 - 67
1 Jan 2012
Aurich M Hofmann GO Mückley T Mollenhauer J Rolauffs B

We attempted to characterise the biological quality and regenerative potential of chondrocytes in osteochondritis dissecans (OCD). Dissected fragments from ten patients with OCD of the knee (mean age 27.8 years (16 to 49)) were harvested at arthroscopy. A sample of cartilage from the intercondylar notch was taken from the same joint and from the notch of ten patients with a traumatic cartilage defect (mean age 31.6 years (19 to 52)). Chondrocytes were extracted and subsequently cultured. Collagen types 1, 2, and 10 mRNA were quantified by polymerase chain reaction. Compared with the notch chondrocytes, cells from the dissecate expressed similar levels of collagen types 1 and 2 mRNA. The level of collagen type 10 message was 50 times lower after cell culture, indicating a loss of hypertrophic cells or genes. The high viability, retained capacity to differentiate and metabolic activity of the extracted cells suggests preservation of the intrinsic repair capability of these dissecates. Molecular analysis indicated a phenotypic modulation of the expanded dissecate chondrocytes towards a normal phenotype. Our findings suggest that cartilage taken from the dissecate can be reasonably used as a cell source for chondrocyte implantation procedures.


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/m2 (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.


The Bone & Joint Journal
Vol. 103-B, Issue 6 | Pages 1096 - 1102
1 Jun 2021
Hamilton DF Shim J Howie CR Macfarlane GJ

Aims

Although total knee arthroplasty (TKA) is a highly successful procedure, about 20% of patients remain dissatisfied postoperatively. This proportion is derived from dichotomous models of the assessment of surgical success or failure, which may not reflect the spectrum of outcomes. The aim of this study was to explore differing responses to surgery, and assess whether there are distinct groups of patients with differing patterns of outcome.

Methods

This was a secondary analysis of a UK multicentre TKA longitudinal cohort study. We used a group-based trajectory modelling analysis of Oxford Knee Score (OKS) in the first year following surgery with longitudinal data involving five different timepoints and multiple predictor variables. Associations between the derived trajectory groups and categorical baseline variables were assessed, and predictors of trajectory group membership were identified using Poisson regression and multinomial logistic regression, as appropriate. The final model was adjusted for sociodemographic factors (age, sex) and baseline OKS.