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1.
Acta Orthop ; 95: 99-107, 2024 Feb 06.
Artículo en Inglés | MEDLINE | ID: mdl-38318961

RESUMEN

BACKGROUND AND PURPOSE: To date, the mid- and long-term outcomes of the Collum Femoris Preserving (CFP) stem compared with conventional straight stems are unknown. We aimed to compare physical function at a 5-year follow-up and implant survival at an average of 10-year follow-up in an randomized controlled trial (RCT). METHODS: This is a secondary report of a double-blinded RCT in 2 hospitals. Patients aged 18-70 years with hip osteoarthritis undergoing an uncemented primary THA were randomized to a CFP or a Zweymüller stem. Patient-reported outcomes, clinical tests, and radiographs were collected at baseline, 2, 3, 4, and 5 years postoperatively. Primary outcome was the Hip disability and Osteoarthritis Outcome Score (HOOS) function in activities of daily living (ADL) subscale. Secondary outcomes were other patient-reported outcomes, clinical tests, adverse events, and implant survival. Kaplan-Meier and competing risk survival analyses were performed with data from the Dutch Arthroplasty Registry. RESULTS: We included 150 patients. Mean difference between groups on the HOOS ADL subscale at 5 years was -0.07 (95% confidence interval -5.1 to 4.9). Overall survival was 92% for the CFP and 96% for the Zweymüller stem. No significant difference was found. CONCLUSION: No significant differences were found in physical function at 5-year and implant survival at 10-year follow-up between the CFP and Zweymüller stems. When taking cup revisions into account, the CFP group showed clinically inferior survival.


Asunto(s)
Artroplastia de Reemplazo de Cadera , Prótesis de Cadera , Osteoartritis de la Cadera , Humanos , Artroplastia de Reemplazo de Cadera/efectos adversos , Artroplastia de Reemplazo de Cadera/métodos , Prótesis de Cadera/efectos adversos , Resultado del Tratamiento , Osteoartritis de la Cadera/cirugía , Osteoartritis de la Cadera/etiología , Cuello Femoral/cirugía , Estudios de Seguimiento , Falla de Prótesis
2.
JAMA Netw Open ; 7(1): e2350765, 2024 Jan 02.
Artículo en Inglés | MEDLINE | ID: mdl-38206628

RESUMEN

Importance: Hip fractures in older adults are serious injuries that result in disability, higher rates of illness and death, and a substantial strain on health care resources. High-quality evidence to improve hip fracture care regarding the surgical approach of hemiarthroplasty is lacking. Objective: To compare 6-month outcomes of the posterolateral approach (PLA) and direct lateral approach (DLA) for hemiarthroplasty in patients with acute femoral neck fracture. Design, Setting, and Participants: This multicenter, randomized clinical trial (RCT) comparing DLA and PLA was performed alongside a natural experiment (NE) at 14 centers in the Netherlands. Patients aged 18 years or older with an acute femoral neck fracture were included, with or without dementia. Secondary surgery of the hip, pathological fractures, or patients with multitrauma were excluded. Recruitment took place between February 2018 and January 2022. Treatment allocation was random or pseudorandom based on geographical location and surgeon preference. Statistical analysis was performed from July 2022 to September 2022. Exposure: Hemiarthroplasty using PLA or DLA. Main Outcome and Measures: The primary outcome was health-related quality of life 6 months after surgery, quantified with the EuroQol Group 5-Dimension questionnaire (EQ-5D-5L). Secondary outcomes included dislocations, fear of falling and falls, activities of daily living, pain, and reoperations. To improve generalizability, a novel technique was used for data fusion of the RCT and NE. Results: A total of 843 patients (542 [64.3%] female; mean [SD] age, 82.2 [7.5] years) participated, with 555 patients in the RCT (283 patients in the DLA group; 272 patients in the PLA group) and 288 patients in the NE (172 patients in the DLA group; 116 patients in the PLA group). In the RCT, mean EQ-5D-5L utility scores at 6 months were 0.50 (95% CI, 0.45-0.55) after DLA and 0.49 (95% CI, 0.44-0.54) after PLA, with 77% completeness. The between-group difference (-0.04 [95% CI, -0.11 to 0.04]) was not statistically significant nor clinically meaningful. Most secondary outcomes were comparable between groups, but PLA was associated with more dislocations than DLA (RCT: 15 of 272 patients [5.5%] in PLA vs 1 of 283 patients [0.4%] in DLA; NE: 6 of 113 patients [5.3%]) in PLA vs 2 of 175 patients [1.1%] in DLA). Data fusion resulted in an effect size of 0.00 (95% CI, -0.04 to 0.05) for the EQ-5D-5L and an odds ratio of 12.31 (95% CI, 2.77 to 54.70) for experiencing a dislocation after PLA. Conclusions and Relevance: This combined RCT and NE found that among patients treated with a cemented hemiarthroplasty after an acute femoral neck fracture, PLA was not associated with a better quality of life than DLA. Rates of dislocation and reoperation were higher after PLA. Randomized and pseudorandomized data yielded similar outcomes, which suggests a strengthening of these findings. Trial Registration: ClinicalTrials.gov Identifier: NCT04438226.


Asunto(s)
Fracturas del Cuello Femoral , Fracturas Espontáneas , Hemiartroplastia , Fracturas de Cadera , Anciano , Anciano de 80 o más Años , Femenino , Humanos , Masculino , Fracturas del Cuello Femoral/cirugía , Fracturas de Cadera/cirugía
3.
Spine J ; 24(3): 462-471, 2024 Mar.
Artículo en Inglés | MEDLINE | ID: mdl-38029931

RESUMEN

BACKGROUND CONTEXT: Congenital and juvenile scoliosis are both early-onset deformities that develop before the age of 10. Children are treated to prevent curve progression and problems in adulthood such as back pain and a decreased quality of life but literature on long-term outcomes remains scarce. PURPOSE: To evaluate the health-related quality of life (HRQoL) and potential disability of children with congenital scoliosis (CS) or juvenile idiopathic scoliosis (JIS) after a minimum of 20 years follow-up. STUDY DESIGN: Comparative cohort study. PATIENT SAMPLE: A consecutive cohort of CS and JIS patients were retrospectively identified from a single-center scoliosis database. Patients born between 1968 and 1981 and treated during skeletal growth were eligible for participation. OUTCOME MEASURES: HRQoL (SF-36, SRS-22r, ODI). METHODS: The primary aim was to evaluate the HRQoL of CS and JIS patients using the general SF-36 questionnaire. Both patient cohorts were compared with age-matched national norms. The secondary aim was to analyze the differences between conservatively and surgically treated patients using the scoliosis-specific Scoliosis Research Society-22r questionnaire (SRS-22r) and the Oswestry Disability Index (ODI). T-tests were used for statistical comparison. RESULTS: In total, 114 patients (67% of the eligible patients) completed the questionnaire, with a mean follow-up of 25.5±5.5 years after their final clinical follow-up. Twenty-nine patients with CS were included with a mean age of 44.4±3.8 years (79.3% female), and 85 patients with JIS with a mean age of 43.7±4.2 years (89.4% female). Of the SF-36 domains, only the vitality score (60.6±18.0 for CS and 58.1±17.6 for JIS cohort) and mental health score (70.0±18.4 for CS and 72.1±18.1 for JIS cohort) were significantly lower compared with the general population (68.6±19.3 for vitality, and 76.8±17.4 for mental health). These decreased scores were larger than the determined minimum clinically important difference threshold of 4.37. Surgically treated JIS patients had a significantly lower score on the SRS-22r pain domain than their nonsurgically treated peers (3.6±0.9 vs 4.1±0.7l p=.019). Surgically treated CS patients had a significantly higher score on the SRS-22r mental health domain than their nonsurgically treated peers (4.3±0.5 vs 3.5±1.0; p=.023). No significant differences were found in the other domains. CONCLUSIONS: Except for vitality and mental health domains, congenital and juvenile idiopathic scoliosis patients treated during skeletal growth had similar HRQoL on most SF-36 domains in adulthood compared with national norms. Surgical treated JIS patients experienced more pain compared with brace treated patients, while braced CS patients had a significantly lower mental scores compared with surgical treated patients. These long-term outcomes are essential to inform patients and can guide shared decision-making between clinicians and patients.


Asunto(s)
Escoliosis , Niño , Humanos , Femenino , Adulto , Persona de Mediana Edad , Masculino , Escoliosis/cirugía , Escoliosis/psicología , Calidad de Vida , Estudios de Cohortes , Estudios de Seguimiento , Estudios Retrospectivos , Dolor
4.
Injury ; 54 Suppl 5: 110764, 2023 Oct.
Artículo en Inglés | MEDLINE | ID: mdl-37923502

RESUMEN

Clinical relevance and statistical significance are different concepts, linked via the sample size calculation. Threshold values for detecting a minimal important change over time are frequently (mis)interpreted as a threshold for the clinical relevance of a difference between groups. The magnitude of a difference between groups that is considered clinically relevant directly impacts the sample size calculation, and thereby the statistical significance in clinical study outcomes. Especially in non-inferiority trials the threshold for clinical relevance, i.e. the predefined margin for non-inferiority, is a crucial choice. A truly inferior treatment will be accepted as non-inferior when this margin is chosen too large. The magnitude of a clinically relevant difference between groups should be carefully considered, by determining the smallest effect for each specific study that is considered worthwhile. This means taking into account the (dis)advantages of both study interventions in terms of benefits, harms, costs, and potential side effects. This article clarifies common sources of confusion, illustrates the implications for clinical research with an example and provides specific suggestions to improve the design and interpretation of clinical research.


Asunto(s)
Relevancia Clínica , Proyectos de Investigación , Humanos
5.
Eur Spine J ; 32(9): 3084-3093, 2023 09.
Artículo en Inglés | MEDLINE | ID: mdl-37318597

RESUMEN

BACKGROUND CONTEXT: Previous studies on the natural history of moderate to severe idiopathic scoliosis show contradictory results. Some studies reported an increased incidence of back pain and disability in severe curves, while other studies reported no difference in health-related quality of life (HRQoL) compared to age-matched adult controls. None of these studies addressed HRQoL using currently recommended and validated questionnaires. PURPOSE: To examine the long-term HRQoL in non-surgically treated adult idiopathic scoliosis patients with a curve of 45° or higher. METHODS: In this retrospective cohort study, all patients were retrospectively identified in the hospital's scoliosis database. Patients (1) with idiopathic scoliosis; (2) born before 1981 (to ensure 25-year follow-up after skeletal maturity); (3) with a curve of 45° or more by Cobb's method at the end of growth; and (4) no spinal surgical treatment were selected. Patients received digital questionnaires of the Short Form-36, Scoliosis Research Society-22, Oswestry Disability Index and Numeric Rating Scale. Outcomes of the SF-36 were compared with a national reference cohort. Additional measures with questions regarding choice of education and occupation were used. RESULTS: Forty-eight of 79 (61%) eligible patients completed the questionnaires, at an average follow-up time of 29.9 ± 7.7 years. Their average age was 51.9 ± 8.0, and median Cobb angle at adolescence was 48.5°. Five of the eight SF-36 subdomains were significantly lower in the scoliosis group compared to the nationwide cohort: physical functioning (73 vs 83, p = 0.011), social functioning (75 vs 84, p = 0.022), role physical functioning (63 vs 76, p = 0.002), role emotional functioning (73 vs 82, p = 0.032), and vitality (56 vs 69, p = < 0.001). The scoliosis-specific SRS-22r score of the patients was 3.7 ± 0.7 on a 0-5 scale. The mean NRS score for pain of all patients was 4.9 ± 3.2, and eight patients (17%) reported a NRS of 0 and 31 (65%) a NRS above 3. At the Oswestry Disability Index, 79% of the patients reported minimal disabilities. Thirty-three patients (69%) reported that their scoliosis had influenced their choice of education. Fifteen patients (31%) reported that their scoliosis had influenced their choice of work. CONCLUSION: Patients with idiopathic scoliosis and curves of 45° or higher have reduced HRQoL. Although many patients experience back pain, the disability reported on the ODI was limited. Scoliosis had noteworthy effect on choice of education.


Asunto(s)
Escoliosis , Adolescente , Humanos , Adulto , Persona de Mediana Edad , Escoliosis/epidemiología , Escoliosis/cirugía , Estudios Retrospectivos , Calidad de Vida , Estudios Transversales , Estudios de Seguimiento , Dolor de Espalda/etiología , Resultado del Tratamiento
6.
Arthroplast Today ; 19: 101053, 2023 Feb.
Artículo en Inglés | MEDLINE | ID: mdl-36845287

RESUMEN

Background: Intraoperative chlorhexidine irrigation could be a valuable additive to systemic antibiotics to prevent infections after total joint arthroplasties. However, it may cause cytotoxicity and impair wound healing. This study evaluates the incidence of infection and wound leakage before and after the introduction of intraoperative chlorhexidine lavage. Methods: All 4453 patients receiving a primary hip or knee prosthesis between 2007 and 2013 in our hospital were retrospectively included. They all underwent intraoperative lavage before wound closure. Initially, wound irrigation with 0.9% NaCl was standard care (n = 2271). In 2008, additional irrigation with a chlorhexidine-cetrimide (CC) solution was gradually introduced (n = 2182). Data on the incidence of prosthetic joint infections and wound leakage, as well as relevant baseline and surgical characteristics, were derived from medical charts. Chi-square analysis was used to compare the incidence of infection and wound leakage between patients with and without CC irrigation. Multivariable logistic regression was used to assess robustness of these effects by adjusting for potential confounders. Results: The prosthetic infection rate was 2.2% in the group without CC irrigation vs 1.3% in the group with CC irrigation (P = .021). Wound leakage occurred in 15.6% of the group without CC irrigation and in 18.8% of the group with CC irrigation (P = .004). However, multivariable analyses showed that both findings were likely due to confounding variables, rather than by the change in intraoperative CC irrigation. Conclusions: Intraoperative wound irrigation using a CC solution does not seem to affect the risk of prosthetic joint infection or wound leakage. Observational data easily yield misleading results, so prospective randomized studies are needed to verify causal inference. Level of Evidence: Level III-uncontrolled before and after the study.

7.
J Shoulder Elbow Surg ; 32(6): 1207-1213, 2023 Jun.
Artículo en Inglés | MEDLINE | ID: mdl-36586507

RESUMEN

BACKGROUND: In this study, we aimed to provide insight into the 90-day complication rates following the Latarjet procedure. Data from 2015 were collected from multiple hospitals in the Netherlands, with different volumes of Latarjet procedures. Our second aim was to examine which patient and surgical factors were associated with complications. METHODS: We conducted a retrospective chart review of 13 hospitals between 2015 and 2022. Data regarding complications within 90 days of Latarjet procedures were extracted. The effect of sex, age, body mass index (BMI), smoking, previous shoulder operations, fixation material, hospital volume, screw size, and operation time on the complication rate was assessed by multivariable logistic regression analysis. RESULTS: Of the 532 included patients, 58 (10.9%) had complications. The most common complications were material failure (n = 19, 3.6%) and nerve injury (n = 13, 2.4%). The risk of complications was lower for male patients than for female patients (odds ratio, 0.40; 95% confidence interval, 0.21-0.77; P = .006). Age, BMI, smoking, previous shoulder operations, type of fixation material, hospital volume, screw size, and operation time were not associated with complications. CONCLUSION: The 90-day complication rate after the Latarjet procedure was 10.9% and was higher in female patients than in male patients. Age, BMI, smoking, previous shoulder operations, type of fixation material, hospital volume, screw size, and operation time did not affect complication rates. We advise setting up a national registry to prevent under-reporting of complications.


Asunto(s)
Inestabilidad de la Articulación , Procedimientos Ortopédicos , Luxación del Hombro , Articulación del Hombro , Humanos , Masculino , Femenino , Luxación del Hombro/cirugía , Articulación del Hombro/cirugía , Procedimientos Ortopédicos/métodos , Estudios Retrospectivos , Inestabilidad de la Articulación/cirugía , Recurrencia , Artroscopía/métodos
8.
Acta Orthop ; 93: 732-738, 2022 09 12.
Artículo en Inglés | MEDLINE | ID: mdl-36097694

RESUMEN

BACKGROUND AND PURPOSE: The posterolateral and direct lateral surgical approach are the 2 most common surgical approaches for performing a hemiarthroplasty in patients with a hip fracture. It is unknown which surgical approach is preferable in terms of (cost-)effectiveness and quality of life. METHODS AND ANALYSIS: We designed a multicenter randomized controlled trial (RCT) with an economic evaluation and a natural experiment (NE) alongside. We will include 555 patients ≥ 18 years with an acute femoral neck fracture. The primary outcome is patient-reported health-related quality of life assessed with the EQ-5D-5L. Secondary outcomes include healthcare costs, complications, mortality, and balance (including fear of falling, actual falls, and injuries due to falling). An economic evaluation will be performed for quality adjusted life years (QALYs). We will use variable block randomization stratified for hospital. For continuous outcomes, we will use linear mixed-model analysis. Dichotomous secondary outcome measures will be analyzed using chi-square statistics and logistic regression models. Primary analyses are based on the intention-to-treat principle. Additional as treated analyses will be performed to evaluate the effect of protocol deviations. Study summary: (i) Largest RCT addressing the health-related patient outcome of the main surgical approaches of hemiarthroplasty. (ii) Focus on outcomes that are important for the patient. (iii) Pragmatic and inclusive RCT with few exclusion criteria, e.g., patients with dementia can participate. (iv) Natural experiment alongside to amplify the generalizability. (v) The first study conducting a costutility analysis comparing both surgical approaches.


Asunto(s)
Artroplastia de Reemplazo de Cadera , Fracturas del Cuello Femoral , Hemiartroplastia , Fracturas de Cadera , Artroplastia de Reemplazo de Cadera/métodos , Análisis Costo-Beneficio , Fracturas del Cuello Femoral/cirugía , Hemiartroplastia/efectos adversos , Hemiartroplastia/métodos , Fracturas de Cadera/cirugía , Humanos , Estudios Multicéntricos como Asunto , Ensayos Clínicos Controlados Aleatorios como Asunto
9.
JAMA Netw Open ; 5(7): e2220394, 2022 07 01.
Artículo en Inglés | MEDLINE | ID: mdl-35802374

RESUMEN

Importance: There is a paucity of high-quality evidence about the long-term effects (ie, 3-5 years and beyond) of arthroscopic partial meniscectomy vs exercise-based physical therapy for patients with degenerative meniscal tears. Objectives: To compare the 5-year effectiveness of arthroscopic partial meniscectomy and exercise-based physical therapy on patient-reported knee function and progression of knee osteoarthritis in patients with a degenerative meniscal tear. Design, Setting, and Participants: A noninferiority, multicenter randomized clinical trial was conducted in the orthopedic departments of 9 hospitals in the Netherlands. A total of 321 patients aged 45 to 70 years with a degenerative meniscal tear participated. Data collection took place between July 12, 2013, and December 4, 2020. Interventions: Patients were randomly allocated to arthroscopic partial meniscectomy or 16 sessions of exercise-based physical therapy. Main Outcomes and Measures: The primary outcome was patient-reported knee function (International Knee Documentation Committee Subjective Knee Form (range, 0 [worst] to 100 [best]) during 5 years of follow-up based on the intention-to-treat principle, with a noninferiority threshold of 11 points. The secondary outcome was progression in knee osteoarthritis shown on radiographic images in both treatment groups. Results: Of 321 patients (mean [SD] age, 58 [6.6] years; 161 women [50.2%]), 278 patients (87.1%) completed the 5-year follow-up with a mean follow-up time of 61.8 months (range, 58.8-69.5 months). From baseline to 5-year follow-up, the mean (SD) improvement was 29.6 (18.7) points in the surgery group and 25.1 (17.8) points in the physical therapy group. The crude between-group difference was 3.5 points (95% CI, 0.7-6.3 points; P < .001 for noninferiority). The 95% CI did not exceed the noninferiority threshold of 11 points. Comparable rates of progression of radiographic-demonstrated knee osteoarthritis were noted between both treatments. Conclusions and Relevance: In this noninferiority randomized clinical trial after 5 years, exercise-based physical therapy remained noninferior to arthroscopic partial meniscectomy for patient-reported knee function. Physical therapy should therefore be the preferred treatment over surgery for degenerative meniscal tears. These results can assist in the development and updating of current guideline recommendations about treatment for patients with a degenerative meniscal tear. Trial Registration: ClinicalTrials.gov Identifier: NCT01850719.


Asunto(s)
Traumatismos de la Rodilla , Osteoartritis de la Rodilla , Lesiones de Menisco Tibial , Femenino , Estudios de Seguimiento , Humanos , Meniscectomía/efectos adversos , Meniscectomía/métodos , Persona de Mediana Edad , Osteoartritis de la Rodilla/cirugía , Modalidades de Fisioterapia , Lesiones de Menisco Tibial/etiología , Lesiones de Menisco Tibial/cirugía
10.
JSES Int ; 6(3): 396-400, 2022 May.
Artículo en Inglés | MEDLINE | ID: mdl-35572444

RESUMEN

Background: It is unclear whether greater tuberosity fractures (GTF) in the setting of a shoulder dislocation are due to an avulsion of the rotator cuff or a result of an extensive Hill-Sachs lesion (HSL). To explore whether these lesions have similar etiology, the primary aim of this study is to compare the postinjury morphology of the proximal humerus after GTF and HSL. Methods: Computed tomography scans of 19 patients with HSL and 18 patients with GTF after first-time shoulder dislocations were analyzed. We assessed the location by measuring height in relation to the highest point of the humerus and angles for the origin (most medial point of lesion), center, and endpoint (most lateral point of lesion) between GTF and HSL and the bicipital groove. For both GTF and HSL, we assessed whether infraspinatus and supraspinatus insertions were involved and whether they were off-track or on-track. Results: Measured from the bicipital groove, HSLs and GTFs have different origins (153˚ vs. 110˚; P < .0001, respectively), centers (125˚ vs. 60˚; P < .0001, respectively), and endpoints (92˚ vs. 37˚; P < .0001, respectively). HSLs had a higher position (0.76 cm vs. 1.71 cm; P < .0001), involved the supraspinatus footprint less often (16% vs. 72%; P = .0008), and were less likely to be off-track (31% vs. 94%; P = .0002). Half of the GTF were on the lateral side of the glenoid track and thus extra-capsular, versus 0% of HSL. Conclusion: HSLs and GTFs have different anatomical characteristics and thus GTFs are likely to be distinct from extensive HSLs.

11.
Children (Basel) ; 9(4)2022 Apr 15.
Artículo en Inglés | MEDLINE | ID: mdl-35455607

RESUMEN

(1) In countries where scoliosis screening programs ended, the responsibility for detection shifted from healthcare professionals to parents. Since recognizing scoliosis is difficult for parents, more patients are presenting late. Increased awareness of scoliosis may favor earlier detection. This study examines the effect of educating parents to recognize scoliosis. (2) In this cross-sectional study a consecutive group of parents completed a digital assessment. They had to complete two identical series of fourteen cases (eight with scoliosis and six without). Each case displayed two photographs of the child's back; one in standing position and one during forward-bending. Based on visual inspection, parents had to indicate if the child had to be referred to a physician. After assessing the first series, information was given on how to detect scoliosis. Subsequently, parents assessed the second series of cases. Sensitivity and specificity were calculated before and after education. (3) A total of 100 parents completed the assessment. The sensitivity to detect scoliosis was slightly but significantly higher after education (68.8% versus 74.0%; p = 0.002), while specificity was not (74.0% versus 74.8%; p = 0.457). (4) This study showed that educating parents improved their ability to recognize scoliosis without increasing the false positive referral rate. Although written instructions can bridge the gap with professional screening programs, the overall sensitivity in this study remained low. Therefore, education can improve the awareness and ability to detect scoliosis, but will not replace screening by professionals.

12.
Acta Orthop ; 93: 451-458, 2022 04 28.
Artículo en Inglés | MEDLINE | ID: mdl-35485295

RESUMEN

BACKGROUND AND PURPOSE: Ceramic liners may reduce early stability of uncemented acetabular components due to higher stiffness. However, the bone ingrowth capacities of porous trabecular titanium might compensate for this effect. This prospective randomized trial quantifies migration patterns of the Delta-TT cup, and compares polyethylene and ceramic liners. PATIENTS AND METHODS: Patients undergoing primary uncemented total hip arthroplasty with the Delta-TT cup and femoral stem with ceramic head were randomized to a polyethylene (n = 25) or ceramic (n = 28) liner. Radiostereometric analysis (RSA) radiographs, patient-reported hip function (HOOS-PS, OHS), and quality of life (EQ5D) were collected at baseline and 1.5, 3, 6, 12, and 24 months postoperatively. Model-based RSA was used to calculate 3D cup translation and rotation, and mixed models were used to compare effects over time between groups. RESULTS: At 2 years follow-up, Delta-TT cups showed similar mean proximal translation of 0.56 mm (95% CI 0.38-0.75) in the ceramic (CE) group and 0.54 mm (0.30-0.77) in the polyethylene (PE) group, with a between group effect of 0.02 mm (-0.20-0.23). Most cup migration occurred in the first 1.5 to 3 months, stabilizing within 6 months. Any between-group effects were ≤ 0.30 mm for translation and ≤ 0.45° for rotation. Improvements in patient-reported hip function and quality of life were similar in both groups. INTERPRETATION: Regardless of liner type, Delta-TT cups showed some initial migration and stabilized within 6 months, which seems promising for long-term fixation in both cup-liner constructs.


Asunto(s)
Artroplastia de Reemplazo de Cadera , Prótesis de Cadera , Artroplastia de Reemplazo de Cadera/efectos adversos , Cerámica , Humanos , Polietileno , Estudios Prospectivos , Diseño de Prótesis , Falla de Prótesis , Calidad de Vida , Análisis Radioestereométrico , Titanio
13.
Knee Surg Sports Traumatol Arthrosc ; 30(6): 1937-1948, 2022 Jun.
Artículo en Inglés | MEDLINE | ID: mdl-35122496

RESUMEN

PURPOSE: Marker-by-treatment analyses are promising new methods in internal medicine, but have not yet been implemented in orthopaedics. With this analysis, specific cut-off points may be obtained, that can potentially identify whether meniscal surgery or physical therapy is the superior intervention for an individual patient. This study aimed to introduce a novel approach in orthopaedic research to identify relevant treatment selection markers that affect treatment outcome following meniscal surgery or physical therapy in patients with degenerative meniscal tears. METHODS: Data were analysed from the ESCAPE trial, which assessed the treatment of patients over 45 years old with a degenerative meniscal tear. The treatment outcome of interest was a clinically relevant improvement on the International Knee Documentation Committee Subjective Knee Form at 3, 12, and 24 months follow-up. Logistic regression models were developed to predict the outcome using baseline characteristics (markers), the treatment (meniscal surgery or physical therapy), and a marker-by-treatment interaction term. Interactions with p < 0.10 were considered as potential treatment selection markers and used these to develop predictiveness curves which provide thresholds to identify marker-based differences in clinical outcomes between the two treatments. RESULTS: Potential treatment selection markers included general physical health, pain during activities, knee function, BMI, and age. While some marker-based thresholds could be identified at 3, 12, and 24 months follow-up, none of the baseline characteristics were consistent markers at all three follow-up times. CONCLUSION: This novel in-depth analysis did not result in clear clinical subgroups of patients who are substantially more likely to benefit from either surgery or physical therapy. However, this study may serve as an exemplar for other orthopaedic trials to investigate the heterogeneity in treatment effect. It will help clinicians to quantify the additional benefit of one treatment over another at an individual level, based on the patient's baseline characteristics. LEVEL OF EVIDENCE: II.


Asunto(s)
Traumatismos de la Rodilla , Lesiones de Menisco Tibial , Artroscopía/métodos , Humanos , Traumatismos de la Rodilla/etiología , Traumatismos de la Rodilla/cirugía , Articulación de la Rodilla/cirugía , Meniscectomía/métodos , Persona de Mediana Edad , Modalidades de Fisioterapia , Lesiones de Menisco Tibial/cirugía
14.
Spine J ; 22(7): 1178-1190, 2022 07.
Artículo en Inglés | MEDLINE | ID: mdl-34963629

RESUMEN

BACKGROUND CONTEXT: One of the controversies in untreated idiopathic scoliosis is the influence of curve size on respiratory function. Whereas scoliosis patients with curves over 90 to 100 degrees are agreed to be at risk for cardiorespiratory failure in later life, the impairment of curves below 90 degrees is generally considered mild. Although various studies showed that pulmonary function is affected in patients with scoliosis, quantification of the relation between curve size and pulmonary function is lacking. PURPOSE: This systematic review with meta-regression analysis aims to characterize the relation between pulmonary function tests and scoliosis severity in children and adolescents with idiopathic scoliosis. STUDY DESIGN: Systematic review with meta-regression analysis. METHODS: Pubmed, Embase, Cochrane, and CINAHL were systematically searched until November 3, 2020, for original articles that reported (1) severity of scoliosis quantified in Cobb angle, and (2) pulmonary function tests in children and adolescents with untreated idiopathic scoliosis. Exclusion criteria were other types of scoliosis, non-original data, post-treatment data, and case reports. All study designs were included, and relevant study details and patient characteristics were extracted. The primary outcome was the effect of Cobb angle on pulmonary function as expressed by the slope coefficient of a linear meta-regression analysis. RESULTS: A total of 126 studies, including 8,723 patients, were retrieved. Meta-regression analysis revealed a statistically significant inverse relation between thoracic Cobb angle and absolute and predicted forced vital capacity in 1 second, forced vital capacity, vital capacity, and total lung capacity. For these outcomes, the slope coefficients showed a decrease of 1% of the predicted pulmonary function per 2.6 to 4.5 degrees of scoliosis. A multivariable meta-regression analysis of potential confounders (age, year of publication, and kyphosis) hardly affected the majority of the outcomes. CONCLUSION: This meta-regression analysis of summary data (means) from 126 studies showed an inverse relationship between the thoracic Cobb angle and pulmonary function. In contrast to previous conclusions, the decline in pulmonary function appears to be gradual over the full range of Cobb angles between <20 and >120 degrees. These findings strengthen the relevance of minimizing curve progression in children with idiopathic scoliosis.


Asunto(s)
Cifosis , Escoliosis , Adolescente , Niño , Humanos , Pulmón , Análisis de Regresión
15.
Clin Shoulder Elb ; 24(2): 98-105, 2021 06.
Artículo en Inglés | MEDLINE | ID: mdl-34078018

RESUMEN

BACKGROUND: Our aim is to determine the interobserver reliability for surgeons to detect Hill-Sachs lesions on magnetic resonance imaging (MRI), the certainty of judgement, and the effects of surgeon characteristics on agreement. METHODS: Twenty-nine patients with Hill-Sachs lesions or other lesions with a similar appearance on MRIs were presented to 20 surgeons without any patient characteristics. The surgeons answered questions on the presence of Hill-Sachs lesions and the certainty of diagnosis. Interobserver agreement was assessed using the Fleiss' kappa (κ) and percentage of agreement. Agreement between surgeons was compared using a technique similar to the pairwise t-test for means, based on large-sample linear approximation of Fleiss' kappa, with Bonferroni correction. RESULTS: The agreement between surgeons in detecting Hill-Sachs lesions on MRI was fair (69% agreement; κ, 0.304; p<0.001). In 84% of the cases, surgeons were certain or highly certain about the presence of a Hill-Sachs lesion. CONCLUSIONS: Although surgeons reported high levels of certainty for their ability to detect Hill-Sachs lesions, there was only a fair amount of agreement between surgeons in detecting Hill-Sachs lesions on MRI. This indicates that clear criteria for defining Hill-Sachs lesions are lacking, which hampers accurate diagnosis and can compromise treatment.

16.
Arthroscopy ; 37(6): 1767-1776.e1, 2021 06.
Artículo en Inglés | MEDLINE | ID: mdl-33556551

RESUMEN

PURPOSE: To determine if long head of the biceps (LHB) tenotomy is not inferior to suprapectoral LHB tenodesis when performed in conjunction with arthroscopic repair of small- to medium-sized nontraumatic rotator cuff tears. METHODS: This multicenter, randomized, non-inferiority trial recruited 100 participants older than 50 years who had a supraspinatus and/or infraspinatus tear sagittally smaller than 3 cm and arthroscopically confirmed LHB pathology. During arthroscopic rotator cuff repair, we randomized 48 patients to undergo suprapectoral LHB tenodesis and 52 patients to undergo LHB tenotomy. Data were collected preoperatively and at 6 weeks, 3 months, and 1 year postoperatively. The primary outcome was non-inferiority of the Constant-Murley score (CMS) at 1-year follow-up. Secondary outcomes included the Dutch Oxford Shoulder Score; Disabilities of the Arm, Shoulder and Hand questionnaire; Popeye deformity; elbow flexion strength index; arm cramping pain; and quality of life (EQ-5D score). The integrity of the rotator cuff repair was assessed with magnetic resonance imaging. Differences between intervention groups were analyzed by mixed modeling. RESULTS: The mean CMS in the LHB tenotomy group improved from 44 (95% confidence interval [CI], 39-48) to 73 (95% CI, 68-79). In patients with LHB tenodesis, the mean CMS improved from 42 (95% CI, 37-48) to 78 (95% CI, 74-82). The difference between groups at 1-year follow-up was 4.8 (97.5% CI, -∞ to 11.4), with a P value for non-inferiority of .06. The secondary outcomes also improved over time, with no remarkable differences between groups. A Popeye deformity occurred in 33% of tenodesis patients and 47% of tenotomy patients (P = .17). Tenotomy was performed with a shorter operative time (73 minutes vs 82 minutes, P = .03). Magnetic resonance imaging showed a recurrent rotator cuff tear in 20% of all cases. CONCLUSIONS: Although statistically "inconclusive" regarding non-inferiority of the CMS at 1-year follow-up, any observed differences between patients with LHB tenotomy and those with LHB tenodesis in all outcome scores were small. LEVEL OF EVIDENCE: Level I, randomized controlled trial and treatment study.


Asunto(s)
Lesiones del Manguito de los Rotadores , Tenodesis , Brazo , Artroscopía , Humanos , Estudios Prospectivos , Calidad de Vida , Lesiones del Manguito de los Rotadores/cirugía , Tenotomía
17.
Health Qual Life Outcomes ; 19(1): 35, 2021 Jan 27.
Artículo en Inglés | MEDLINE | ID: mdl-33499876

RESUMEN

OBJECTIVES: To determine the level of agreement between both proxy versions and the self-completed EQ-5D-5L. DESIGN: A randomized agreement study. SETTING AND PARTICIPANTS: We recruited 120 patients (compos mentis) and their proxies at the orthopaedic outpatient clinic. Patients completed the regular EQ-5D-5L and their proxy completed the proxy version of the EQ-5D-5L and rated the patients' health from their own (proxy-proxy) perspective (i.e. how do you rate the health of the patient), and from the patient's (proxy-patient) perspective (i.e. how do you think the patient would rate their own health if they were able to). MEASURES: The primary outcome was the agreement between patients and their proxy, quantified as the intra class correlation coefficient for the EQ-5D-5L Utility score. RESULTS: Average Utility scores were 0.65 with the self completed EQ-5D-5L, versus 0.60 with the proxy-patient version and 0.58 with the proxy-proxy version. The ICC was 0.66 (95% CI 0.523, 0.753) for the proxy-patient perspective and 0.58 (95% CI 0.411, 0.697) for the proxy-proxy perspective. The mean gold standard score of the VAS-Health was 69.7 whereas the proxy-proxy perspective was 66.5 and the proxy-patient perspective was 66.3. CONCLUSION AND IMPLICATIONS: The proxy-patient perspective yielded substantial agreement with the self completed EQ-5D-5L, while the agreement with the proxy-proxy perspective was moderate. In this study population of patients without cognitive impairment, proxies tended to underestimate the quality of life of their relative.


Asunto(s)
Apoderado , Calidad de Vida/psicología , Esposos/psicología , Adulto , Femenino , Humanos , Masculino , Persona de Mediana Edad , Ortopedia , Psicometría , Encuestas y Cuestionarios
18.
Hip Int ; 31(2): 154-165, 2021 Mar.
Artículo en Inglés | MEDLINE | ID: mdl-32552010

RESUMEN

BACKGROUND: The posterolateral approach (PLA) and direct lateral approach (DLA) are the most commonly used approaches for inserting a hemiarthroplasty in the treatment of femoral neck fractures. A recent review concluded that the routine use of PLA should be questioned, but this conclusion itself can be questioned. The aim of this study is to provide an updated overview and critical appraisal of the available evidence, focussing on outcomes most relevant for patients. METHODS: We conducted a comprehensive search of literature in the MEDLINE and EMBASE databases and Cochrane Library. Studies (till June 2018) to identify hip fracture clinical trials/comparative studies comparing alternative surgical approaches (PLA and DLA). We explored sources of heterogeneity and conducted pooled analyses when appropriate. RESULTS: 264 potentially eligible studies were identified of which 1 RCT, 3 prospective, 3 registry data and 5 retrospective studies were included. The RCT consisted performance and attrition bias. The mean MINORS score of the prospective/register studies was 17.3 (SD 3.5) and 13.8 (SD 1.9) of the 5 retrospective studies. The GRADE score for all the outcomes was very low. Due to the high and various types of biases across the included studies, we did not pool the data. None of studies assessed the activities of daily living functionality. 6 studies reported significantly more dislocations or reoperations due to dislocation in the PLA group, 6 other studies found no differences. DLA patients were more likely to develop abductor insufficiency leading to limping and more need for walking aids. The PLA patients tended to have better quality of life, less pain and more satisfaction compared to the DLA patients. CONCLUSION: Based on low-quality studies, PLA may be associated with more dislocations, but patients had less walking problems and a lower tendency to abductor insufficiency compared with DLA. Further clinical trials with methodology rigor are needed to determine which approach is more effective in terms of outcomes relevant to patients.


Asunto(s)
Fracturas del Cuello Femoral , Hemiartroplastia , Actividades Cotidianas , Fracturas del Cuello Femoral/cirugía , Hemiartroplastia/efectos adversos , Humanos , Estudios Prospectivos , Calidad de Vida , Estudios Retrospectivos , Resultado del Tratamiento
19.
Orthop J Sports Med ; 8(10): 2325967120954392, 2020 Oct.
Artículo en Inglés | MEDLINE | ID: mdl-33195707

RESUMEN

BACKGROUND: It is unknown whether the treatment effects of partial meniscectomy and physical therapy differ when focusing on activities most valued by patients with degenerative meniscal tears. PURPOSE: To compare partial meniscectomy with physical therapy in patients with a degenerative meniscal tear, focusing on patients' most important functional limitations as the outcome. STUDY DESIGN: Randomized controlled trial; Level of evidence, 1. METHODS: This study is part of the Cost-effectiveness of Early Surgery versus Conservative Treatment with Optional Delayed Meniscectomy for Patients over 45 years with non-obstructive meniscal tears (ESCAPE) trial, a multicenter noninferiority randomized controlled trial conducted in 9 orthopaedic hospital departments in the Netherlands. The ESCAPE trial included 321 patients aged between 45 and 70 years with a symptomatic, magnetic resonance imaging-confirmed meniscal tear. Exclusion criteria were severe osteoarthritis, body mass index >35 kg/m2, locking of the knee, and prior knee surgery or knee instability due to an anterior or posterior cruciate ligament rupture. This study compared partial meniscectomy with physical therapy consisting of a supervised incremental exercise protocol of 16 sessions over 8 weeks. The main outcome measure was the Dutch-language equivalent of the Patient-Specific Functional Scale (PSFS), a secondary outcome measure of the ESCAPE trial. We used crude and adjusted linear mixed-model analyses to reveal the between-group differences over 24 months. We calculated the minimal important change for the PSFS using an anchor-based method. RESULTS: After 24 months, 286 patients completed the follow-up. The partial meniscectomy group (n = 139) improved on the PSFS by a mean of 4.8 ± 2.6 points (from 6.8 ± 1.9 to 2.0 ± 2.2), and the physical therapy group (n = 147) improved by a mean of 4.0 ± 3.1 points (from 6.7 ± 2.0 to 2.7 ± 2.5). The crude overall between-group difference showed a -0.6-point difference (95% CI, -1.0 to -0.2; P = .004) in favor of the partial meniscectomy group. This improvement was statistically significant but not clinically meaningful, as the calculated minimal important change was 2.5 points on an 11-point scale. CONCLUSION: Both interventions were associated with a clinically meaningful improvement regarding patients' most important functional limitations. Although partial meniscectomy was associated with a statistically larger improvement at some follow-up time points, the difference compared with physical therapy was small and clinically not meaningful at any follow-up time point. REGISTRATION: NCT01850719 (ClinicalTrials.gov identifier) and NTR3908 (the Netherlands Trial Register).

20.
Acta Orthop ; 91(5): 514-519, 2020 10.
Artículo en Inglés | MEDLINE | ID: mdl-32746668

RESUMEN

Background and purpose - Dislocation is the leading reason for early revision surgery after total hip arthroplasty (THA). The dual-mobility (DM) cup was developed to provide more stability and mechanically reduce the risk of dislocation. Despite the increased use of DM cups, high-quality evidence of their (cost-)effectiveness is lacking. The primary objective of this randomized controlled trial (RCT) is to investigate whether there is a difference in the number of hip dislocations following primary THA, using the posterolateral approach, with a DM cup compared with a unipolar (UP) cup in elderly patients 1 year after surgery. Secondary outcomes include the number of revision surgeries, patient-reported outcome measures (PROMs), and cost-effectiveness.Methods and analysis - This is a prospective multicenter nationwide, single-blinded RCT nested in the Dutch Arthroplasty Registry. Patients ≥ 70 years old, undergoing elective primary THA using the posterolateral approach, will be eligible. After written informed consent, 1,100 participants will be randomly allocated to the intervention or control group. The intervention group receives a THA with a DM cup and the control group a THA with a UP cup. PROMs are collected preoperatively, and 3 months, 1 and 2 years postoperatively. Primary outcome is the difference in number of dislocations between the UP and DM cup within 1 year, reported in the registry (revisions), or by the patients (closed or open reduction). Data will be analyzed using multilevel models as appropriate for each outcome (linear/logistic/survival). An economic evaluation will be performed from the healthcare and societal perspective, for dislocation and quality adjusted life years (QALYs).Trial registration - This RCT is registered at www.clinicaltrials.gov with identification number NCT04031820.


Asunto(s)
Artroplastia de Reemplazo de Cadera , Luxación de la Cadera/prevención & control , Fracturas de Cadera/cirugía , Prótesis de Cadera , Complicaciones Posoperatorias/prevención & control , Ensayos Clínicos Controlados Aleatorios como Asunto/métodos , Anciano , Humanos , Países Bajos , Estudios Prospectivos , Diseño de Prótesis , Sistema de Registros , Método Simple Ciego
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