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  1. Article ; Online: Comparison of early migration patterns between a ceramic and polyethylene liner in uncemented Trabecular Titanium cups: a 2-year randomized controlled trial of 52 hips using radiostereometric analysis.

    Klaassen, Amanda D / Schäffer, Elisabeth A / Willigenburg, Nienke W / Van Beers, Loes W A H / Scholtes, Vanessa A B / Van der Hulst, Victor P M / Koster, Lennard A / Kaptein, Bart L / Moojen, Dirk Jan F / Poolman, Rudolf W

    Acta orthopaedica

    2022  Volume 93, Page(s) 451–458

    Abstract: 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 ... ...

    Abstract 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.
    MeSH term(s) Arthroplasty, Replacement, Hip/adverse effects ; Ceramics ; Hip Prosthesis ; Humans ; Polyethylene ; Prospective Studies ; Prosthesis Design ; Prosthesis Failure ; Quality of Life ; Radiostereometric Analysis ; Titanium
    Chemical Substances Polyethylene (9002-88-4) ; Titanium (D1JT611TNE)
    Language English
    Publishing date 2022-04-28
    Publishing country Sweden
    Document type Journal Article ; Randomized Controlled Trial
    ZDB-ID 2180677-9
    ISSN 1745-3682 ; 1745-3674
    ISSN (online) 1745-3682
    ISSN 1745-3674
    DOI 10.2340/17453674.2022.2267
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  2. Article ; Online: Digital medical history implementation to triage orthopaedic patients during COVID-19: Findings from a rapid cycle, semi-randomised A/B testing quality improvement project.

    Bernstein, David N / van de Graaf, Victor A / Meijers, Irina / Portengen, Anne / Klaassen, Amanda / Scholtes, Vanessa A B / Poolman, Rudolf W / Kempen, Diederik H R

    Musculoskeletal care

    2021  Volume 20, Issue 2, Page(s) 390–395

    Abstract: ... utilised.: Methods: We analysed 640 patients using a rapid cycle, semi-randomised A/B testing approach ...

    Abstract Introduction: The COVID-19 pandemic severely impacted musculoskeletal care. To better triage the notable backlog of patients, we assessed whether a digital medical history (DMH), a summary of health information and concerns completed by the patient prior to a clinic visit, could be routinely collected and utilised.
    Methods: We analysed 640 patients using a rapid cycle, semi-randomised A/B testing approach. Four rapid cycles of different randomised interventions were conducted across five unique patient groups. Descriptive statistics were used to report DMH completion rates by cycle/patient group and intervention. Multivariable logistic regression was used to determine whether age or anatomic injury location was associated DMH completion.
    Ethical approval: N/A (Quality Improvement Project) RESULTS: Across all patients, the DMH completion rate was 48% (307/640). Phone calls were time consuming and resource intensive without an increased completion rate. The highest rate of DMH completion was among patients who were referred and called the clinic themselves (78% of patients [63 out of 81 patients]). Across all patients, increasing age (odds ratio [OR]: 0.985 (95% CI: 0.976-0.995), p = 0.002), patients with back concerns (OR: 0.395 (95% CI: 0.234-0.666), p = 0.001), and patients with non-specific/other musculoskeletal concerns (OR: 0.331 (95% CI: 0.176-0.623), p = 0.001) were associated with decreased odds of DMH completion.
    Discussion and conclusion: DMHs can be valuable in helping triage orthopaedic patients in resource-strapped settings, times of crisis, or as we transition towards value-based health care delivery. However, further work is needed to continue to increase the completion rate about 50%.
    MeSH term(s) COVID-19/epidemiology ; Dimenhydrinate ; Humans ; Orthopedics ; Pandemics ; Quality Improvement ; Triage
    Chemical Substances Dimenhydrinate (JB937PER5C)
    Language English
    Publishing date 2021-11-30
    Publishing country England
    Document type Journal Article ; Randomized Controlled Trial
    ZDB-ID 2171452-6
    ISSN 1557-0681 ; 1478-2189
    ISSN (online) 1557-0681
    ISSN 1478-2189
    DOI 10.1002/msc.1605
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  3. Article ; Online: Responsiveness and interpretability of the Animated Activity Questionnaire for assessing activity limitations of patients with hip or knee osteoarthritis.

    Peter, Wilfred F / Poolman, Rudolf W / Scholtes, Vanessa A B / de Vet, Henrika C W / Terwee, Caroline B

    Musculoskeletal care

    2019  Volume 17, Issue 4, Page(s) 327–334

    Abstract: Purpose: The aim of the study was to determine the responsiveness and interpretability of the Animated Activity Questionnaire (AAQ), an online questionnaire in which osteoarthritis patients select animations that best match their performance of daily ... ...

    Abstract Purpose: The aim of the study was to determine the responsiveness and interpretability of the Animated Activity Questionnaire (AAQ), an online questionnaire in which osteoarthritis patients select animations that best match their performance of daily activities.
    Methods: A longitudinal study was carried out, in which 94 patients with hip or knee osteoarthritis were assessed at baseline, and 3 and 6 months after treatment (conservative and surgical). Responsiveness was assessed by means of testing hypotheses about expected correlations between change in AAQ, a Global Rating Scale of change (GRS) and change in the Activities of Daily Living subscale of the Hip disability or Knee injury and Osteoarthritis Outcome Score (H/KOOS), and a combination of performance-based tests (the 30 s chair-stand test, the timed up-and-go test and the nine-step stair climbing test). The minimal important change (MIC) was estimated by means of the receiving operating characteristics (ROC) method.
    Results: The correlations of the AAQ with the H/KOOS were as expected, but other correlations were lower than anticipated. The area under the ROC curve was 0.74 at 6 months. At 3 months' follow-up, the correlations were too low to calculate a MIC. A total of 20% of the results at 3 months and 80% of the results at 6 months were in accordance with the hypotheses. The MIC was 9 points at 6 months.
    Conclusions: The AAQ was sufficiently responsive at the six-months follow-up, but not at the three-month follow-up. The MIC at the 6-month follow-up (9 points) was slightly lower than the smallest detectable change of 14 points found in a previous study.
    MeSH term(s) Activities of Daily Living ; Aged ; Female ; Humans ; Longitudinal Studies ; Male ; Middle Aged ; Osteoarthritis, Hip/rehabilitation ; Osteoarthritis, Knee/rehabilitation ; Severity of Illness Index ; Surveys and Questionnaires
    Language English
    Publishing date 2019-08-12
    Publishing country England
    Document type Evaluation Study ; Journal Article ; Research Support, Non-U.S. Gov't
    ZDB-ID 2171452-6
    ISSN 1557-0681 ; 1478-2189
    ISSN (online) 1557-0681
    ISSN 1478-2189
    DOI 10.1002/msc.1418
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  4. Article ; Online: Can We Measure the Heel Bump? Radiographic Evaluation of Haglund's Deformity.

    Bulstra, Gythe H / van Rheenen, Thijs A / Scholtes, Vanessa A B

    The Journal of foot and ankle surgery : official publication of the American College of Foot and Ankle Surgeons

    2015  Volume 54, Issue 3, Page(s) 338–340

    Abstract: Haglund's deformity is a symptomatic posterosuperior deformity of the heel. The lateral radiograph of the ankle will show a prominent, large, posterosuperior part of the calcaneus, which can be measured using the Fowler and Philips angle (FPA, the angle ... ...

    Abstract Haglund's deformity is a symptomatic posterosuperior deformity of the heel. The lateral radiograph of the ankle will show a prominent, large, posterosuperior part of the calcaneus, which can be measured using the Fowler and Philips angle (FPA, the angle between the posterior and plantar surface of the calcaneus) and the calcaneal pitch angle (CPA, the angle between the sole of the foot and the plantar part of the calcaneus). Although these angles are commonly used, these radiographic angle measurements have never shown a relationship with Haglund's deformity. In 78 patients (51% male) with symptomatic Haglund's deformity and a control group of 100 patients (41% male) with no heel complaints, we measured the FPA and CPA on weightbearing lateral radiographs of the foot. Using an unpaired t tests, no significant difference was found between the 2 groups in the FPA (p = .40). We measured a significant difference in the CPA between the Haglund group and the control group (p = .014). Subgroup analysis showed that this difference was mainly found in females (p < .00), with no significant difference seen in the males (p < .48). Females with Haglund's deformity will have a greater CPA than will females without Haglund's deformity. The CPA showed a difference between the Haglund and non-Haglund groups, although mainly in females. Although the evidence from our study is limited, it would be interesting to study the CPA further, because it implicates the verticalization of the calcaneus. This change in position results in extra traction on the Achilles tendon and can eventually cause tendinitis and bursitis. Radiographic measurement should be used as an auxiliary tool. If the calcaneus tends to change position, it would be interesting to understand this process, which could eventually lead to improvement in the treatment of Haglund's deformity.
    MeSH term(s) Calcaneus/anatomy & histology ; Female ; Foot/diagnostic imaging ; Heel/abnormalities ; Heel/diagnostic imaging ; Humans ; Male ; Radiography
    Language English
    Publishing date 2015-05
    Publishing country United States
    Document type Journal Article
    ZDB-ID 1146972-9
    ISSN 1542-2224 ; 1067-2516
    ISSN (online) 1542-2224
    ISSN 1067-2516
    DOI 10.1053/j.jfas.2014.07.006
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  5. Article ; Online: Increased Persistent Mid-Thigh Pain After Short-Stem Compared With Wedge-Shaped Straight-Stem Uncemented Total Hip Arthroplasty at Medium-Term Follow-Up: A Randomized Double-Blinded Cross-Sectional Study.

    Gielis, Willem Paul / van Oldenrijk, Jakob / Ten Cate, Nick / Scholtes, Vanessa A B / Geerdink, Carel H / Poolman, Rudolf W

    The Journal of arthroplasty

    2019  Volume 34, Issue 5, Page(s) 912–919

    Abstract: Background: Femoral prosthesis design may impact the frequency of mid-thigh pain. We compared current, incidental, and persistent mid-thigh pain between the short-stem, Collum Femoris femur prosthesis, and the wedge shaped straight-stem, Zweymüller ... ...

    Abstract Background: Femoral prosthesis design may impact the frequency of mid-thigh pain. We compared current, incidental, and persistent mid-thigh pain between the short-stem, Collum Femoris femur prosthesis, and the wedge shaped straight-stem, Zweymüller femur prosthesis and studied the associations between demographics, radiographic measurements, and mid-thigh pain.
    Methods: We contacted patients from a randomized controlled trial who underwent uncemented total hip arthroplasty (THA) for hip osteoarthritis at a mean follow-up of 44 months (range 24-64 months). Patients were specifically assessed for current (during assessment), incidental (any time postoperatively for >1 week) mid-thigh pain, and persistent (any time postoperatively for >2 years) mid-thigh pain. Furthermore, we used regression analysis to study associations between demographics, radiographic measurements, and mid-thigh pain.
    Results: One hundred forty of 150 patients (93%) responded to our assessment. Mean age at the time of operation was 62 years (±7.0). Current mid-thigh pain occurred in 16 patients (23%) in the Collum Femoris Preserving (CFP) group compared with 10 patients (14%) in the Zweymüller group (P = .192). Incidental mid-thigh pain occurred in 24 patients (34%) in the CFP group compared with 15 patients (21%) in the Zweymüller group (P = .090). Persistent mid-thigh pain was found in 13 patients (19%) in the CFP group compared with five patients (7%) in the Zweymüller group (P = .043). Varus malalignment (odds ratio 1.819 [95% confidence interval 1.034-3.200]) and leg lengthening (odds ratio 1.107 per cm lengthening [95% confidence interval 1.026-1.195]) showed significant associations with mid-thigh pain.
    Conclusions: We found more persistent mid-thigh pain after short-stem uncemented THA compared to wedge-shaped straight-stem uncemented THA during medium-term follow-up. Varus malalignment and leg lengthening were associated with mid-thigh pain.
    MeSH term(s) Aged ; Arthroplasty, Replacement, Hip/adverse effects ; Arthroplasty, Replacement, Hip/instrumentation ; Cross-Sectional Studies ; Double-Blind Method ; Female ; Femur/surgery ; Femur Neck/surgery ; Hip Prosthesis/adverse effects ; Humans ; Male ; Middle Aged ; Osteoarthritis, Hip/surgery ; Pain, Postoperative/etiology ; Postoperative Period ; Prosthesis Design/adverse effects ; Thigh ; Treatment Outcome
    Language English
    Publishing date 2019-01-23
    Publishing country United States
    Document type Journal Article ; Multicenter Study ; Randomized Controlled Trial ; Research Support, Non-U.S. Gov't
    ZDB-ID 632770-9
    ISSN 1532-8406 ; 0883-5403
    ISSN (online) 1532-8406
    ISSN 0883-5403
    DOI 10.1016/j.arth.2019.01.014
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  6. Article ; Online: Feedback to Patients About Patient-reported Outcomes Does Not Improve Empowerment or Satisfaction.

    Ackermans, Lisette / Hageman, Michiel G / Bos, A H / Haverkamp, Daniel / Scholtes, Vanessa A B / Poolman, Rudolf W

    Clinical orthopaedics and related research

    2018  Volume 476, Issue 4, Page(s) 716–722

    Abstract: Background: Although patient-reported outcome measures (PROMs) are helpful to define whether an intervention has improved a patient's status in ways the patient feels are important, they may also serve an empowering educational role; specifically, ... ...

    Abstract Background: Although patient-reported outcome measures (PROMs) are helpful to define whether an intervention has improved a patient's status in ways the patient feels are important, they may also serve an empowering educational role; specifically, sharing a patient's scores might help the patient understand his or her progress during treatment. However, whether sharing PROM scores in this way improves the sense of empowerment or satisfaction with the process of care has not been well explored. Also, less is known whether specific demographic factors or coping strategies are associated with empowerment.
    Questions/purposes: We asked the following: (1) Does giving patients feedback on their PROM scores improve a patient's sense of empowerment or satisfaction? (2) Do demographic factors, duration of disability, or self-efficacy correlate with patient empowerment?
    Methods: In this prospective cohort study, we assigned patients with osteoarthritis of the knee or hip sequentially such that the first 70 patients did not receive the intervention and the next 72 did. Patients enrolled in the control cohort were managed according to standard care, whereas patients enrolled in the intervention cohort completed web-based questionnaires measuring their physical function and pain. After filling out the questionnaires, a printout with the scores was given to the patients providing feedback about their physical function and pain. The primary outcome measure was patient empowerment, as measured by the Patient Activation Measure. Secondary outcomes were patient satisfaction, as measured by an 11-point Likert scale and Patient Doctor Relation Questionnaire. Independent variables were demographic factors and coping, measured by the Pain Self-efficacy Questionnaire. Bivariate and multivariable analyses were performed to determine the influence of the feedback. Although no minimum clinically important differences have been defined for the patient empowerment or satisfaction scales, we believe that differences smaller than 10% are unlikely to be clinically important, even if they are statistically significant.
    Results: Although the group that received PROM feedback had higher scores for empowerment than the group that did not, the effect size was small and likely not to have been clinically important (2.8 ± 0.85 versus 3.1 ± 0.811; mean difference -0.31; 95% confidence interval, 2.8-3.1; p = 0.037). With the numbers available, there were no differences between the group given PROM feedback and the group that did not receive such feedback in terms of satisfaction scores (8.6 ± 1.4 versus 8.8 ± 1.2; mean difference -0.19; p = 0.39). After controlling for demographic factors such as level of education and duration of complaint, we found that the group that received PROM feedback and who had a higher level of self-efficacy had higher scores for empowerment than the group that did not, although the effect size was small.
    Conclusions: PROM feedback did not have a clinically important impact on empowerment or satisfaction. This might indicate that counseling based on PROMs during a single visit may be ineffective. The most important positive finding is that more effective coping strategies are associated with greater patient empowerment.
    Level of evidence: Level II, therapeutic study.
    MeSH term(s) Adaptation, Psychological ; Aged ; Disability Evaluation ; Feedback, Psychological ; Female ; Health Knowledge, Attitudes, Practice ; Humans ; Male ; Middle Aged ; Osteoarthritis, Hip/diagnosis ; Osteoarthritis, Hip/physiopathology ; Osteoarthritis, Hip/psychology ; Osteoarthritis, Hip/therapy ; Osteoarthritis, Knee/diagnosis ; Osteoarthritis, Knee/physiopathology ; Osteoarthritis, Knee/psychology ; Osteoarthritis, Knee/therapy ; Pain Measurement ; Patient Participation ; Patient Reported Outcome Measures ; Patient Satisfaction ; Predictive Value of Tests ; Prospective Studies ; Self Efficacy
    Language English
    Publishing date 2018-03-23
    Publishing country United States
    Document type Journal Article
    ZDB-ID 80301-7
    ISSN 1528-1132 ; 0009-921X
    ISSN (online) 1528-1132
    ISSN 0009-921X
    DOI 10.1007/s11999.0000000000000069
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  7. Article ; Online: What makes a measurement instrument valid and reliable?

    Scholtes, Vanessa A / Terwee, Caroline B / Poolman, Rudolf W

    Injury

    2011  Volume 42, Issue 3, Page(s) 236–240

    Abstract: High quality instruments are useful tools for clinical and research purposes. To determine whether an instrument has high quality, measurement properties such as reliability and validity need to be assessed, using standardised criteria. This paper ... ...

    Abstract High quality instruments are useful tools for clinical and research purposes. To determine whether an instrument has high quality, measurement properties such as reliability and validity need to be assessed, using standardised criteria. This paper discusses these quality domains and measurement properties using the standardised criteria that were recently published by the COSMIN group. Examples are given of studies evaluating the measurement properties of instruments frequently used in trauma. This paper presents a helpful tool for readers who want to evaluate or assess the quality of a measurement instrument on reliability and validity.
    MeSH term(s) Clinical Protocols/standards ; Data Interpretation, Statistical ; Health Status Indicators ; Humans ; Outcome Assessment (Health Care)/standards ; Reproducibility of Results ; Research Design/standards ; Selection Bias ; Wounds and Injuries/therapy
    Language English
    Publishing date 2011-03
    Publishing country Netherlands
    Document type Journal Article
    ZDB-ID 218778-4
    ISSN 1879-0267 ; 0020-1383
    ISSN (online) 1879-0267
    ISSN 0020-1383
    DOI 10.1016/j.injury.2010.11.042
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  8. Article: Does Computed Tomography Change our Observation and Management of Fracture Non-Unions?

    Kleinlugtenbelt, Ydo V / Scholtes, Vanessa A B / Toor, Jay / Amaechi, Christian / Maas, Mario / Bhandari, Mohit / Poolman, Rudolf W / Kloen, Peter

    The archives of bone and joint surgery

    2016  Volume 4, Issue 4, Page(s) 337–342

    Abstract: Background: The purpose of this study was to determine whether Multi-Detector Computed Tomography (MDCT) in addition to plain radiographs influences radiologists' and orthopedic surgeons' diagnosis and treatment plans for delayed unions and non-unions.!# ...

    Abstract Background: The purpose of this study was to determine whether Multi-Detector Computed Tomography (MDCT) in addition to plain radiographs influences radiologists' and orthopedic surgeons' diagnosis and treatment plans for delayed unions and non-unions.
    Methods: A retrospective database of 32 non-unions was reviewed by 20 observers. On a scale of 1 to 5, observers rated on X-Ray and a subsequent Multi Detector Helical Computer Tomography (MDCT) scan was performed to determine the following categories: "healed", "bridging callus present", "persistent fracture line" or "surgery advised". Interobserver reliability in each category was calculated using the Interclass Correlation Coefficient (ICC). The influence of the MDCT scan on the raters' observations was determined in each case by subtracting the two scores of both time points.
    Results: All four categories show fair interobserver reliability when using plain radiographs. MDCT showed no improvement, the reliability was poor for the categories "bridging callus present" and "persistent fracture line", and fair for "healed" and "surgery advised". In none of the cases, MDCT led to a change of management from nonoperative to operative treatment or vice versa. For 18 out of 32 cases, the treatment plans did not alter. In seven cases MDCT led to operative treatment while on X-ray the treatment plan was undecided.
    Conclusion: In this study, the interobserver reliability of MDCT scan is not greater than conventional radiographs for determining non-union. However, a MDCT scan did lead to a more invasive approach in equivocal cases. Therefore a MDCT is only recommended for making treatment strategies in those cases.
    Language English
    Publishing date 2016-11-09
    Publishing country Iran
    Document type Journal Article
    ZDB-ID 2782053-1
    ISSN 2345-461X ; 2345-4644
    ISSN (online) 2345-461X
    ISSN 2345-4644
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  9. Article ; Online: Test-retest reliability of the 20-sec Wingate test to assess anaerobic power in children with cerebral palsy.

    Dallmeijer, Annet J / Scholtes, Vanessa A B / Brehm, Merel-Anne / Becher, Jules G

    American journal of physical medicine & rehabilitation

    2013  Volume 92, Issue 9, Page(s) 762–767

    Abstract: Objective: The aim of this study was to determine the test-retest reliability of the 20-sec Wingate anaerobic test in children with cerebral palsy.: Design: Participants were 22 ambulant children with cerebral palsy, with Gross Motor Function ... ...

    Abstract Objective: The aim of this study was to determine the test-retest reliability of the 20-sec Wingate anaerobic test in children with cerebral palsy.
    Design: Participants were 22 ambulant children with cerebral palsy, with Gross Motor Function Classification System levels I (limitations in advanced motor skills, n = 11), II (limitations in walking, n = 7), and III (walking with walking aids, n = 4), aged 7-13 yrs. All children performed two 20-sec full-out sprint tests on a bicycle ergometer within 1-3 wks. Mean power and peak power (W/kg) were calculated as an estimate of anaerobic power. Test-retest reliability was determined by calculating the intraclass correlation coefficient (ICC) and standard error of measurement (SEM). Values were shown for the total group and Gross Motor Function Classification System I and II/III separately.
    Results: The test-retest reliability of mean power output was excellent for children with Gross Motor Function Classification System level I (ICC, 0.96; SEM, 5.4%) and II/III (ICC, 0.99; SEM, 6.1%). Peak power output showed a lower reliability in both Gross Motor Function Classification System I (ICC, 0.87; SEM, 9.4%) and II/III (ICC, 0.96; SEM, 11.7%).
    Conclusions: Anaerobic testing using a 20-sec Wingate bicycle test is reliable in ambulant school-aged children with cerebral palsy.
    MeSH term(s) Adolescent ; Anaerobic Threshold/physiology ; Cerebral Palsy/diagnosis ; Cerebral Palsy/rehabilitation ; Child ; Cohort Studies ; Disability Evaluation ; Disabled Children ; Exercise Test/methods ; Female ; Humans ; Male ; Physical Endurance/physiology ; Reproducibility of Results ; Risk Factors ; Severity of Illness Index ; Time Factors ; Walking/physiology
    Language English
    Publishing date 2013-09
    Publishing country United States
    Document type Comparative Study ; Journal Article
    ZDB-ID 219390-5
    ISSN 1537-7385 ; 0002-9491 ; 0894-9115
    ISSN (online) 1537-7385
    ISSN 0002-9491 ; 0894-9115
    DOI 10.1097/PHM.0b013e318278a7ab
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  10. Article ; Online: Better early functional outcome after short stem total hip arthroplasty? A prospective blinded randomised controlled multicentre trial comparing the Collum Femoris Preserving stem with a Zweymuller straight cementless stem total hip replacement for the treatment of primary osteoarthritis of the hip.

    van Oldenrijk, Jakob / Scholtes, Vanessa A B / van Beers, Loes W A H / Geerdink, Carel H / Niers, Bob B A M / Runne, Wouter / Bhandari, Mohit / Poolman, Rudolf W

    BMJ open

    2017  Volume 7, Issue 10, Page(s) e014522

    Abstract: Objectives: Primary aim was to compare the functional results at 3 months and 2 years between short and conventional cementless stem total hip arthroplasty (THA). Secondary aim was to determine the feasibility of a double-blind implant-related trial.: ...

    Abstract Objectives: Primary aim was to compare the functional results at 3 months and 2 years between short and conventional cementless stem total hip arthroplasty (THA). Secondary aim was to determine the feasibility of a double-blind implant-related trial.
    Design: A prospective blinded randomised controlled multicentre trial in patients with osteoarthritis of the hip. All patients, research assistants, clinical assessors, investigators and data analysts were blinded to the type of prosthesis.
    Population: 150 patients between 18 and 70 years with osteoarthritis of the hip, 75 in the short stem and 75 in the conventional stem group. Mean age: 60 years (SD 7).
    Interventions: the Collum Femoris Preserving short stem versus the Zweymuller Alloclassic conventional stem.
    Main outcome measures: The Dutch version of the Hip Disability and Osteoarthritis Outcome Score (HOOS). Secondary outcomes measures: Harris Hip Score, the Physical Component Scale of the SF12, the Timed Up and Go test, Pain and the EQ-5D. Feasibility outcomes: continued blinding, protocol adherence and follow-up success rate.
    Results: No significant difference between the two groups. Mean HOOS total score in the short stem group increased 32.7 points from 36.6 (95% CI 32.9 to 40.2) preoperatively to 69.3 (95% CI 66.4 to 72.1) at 3 months follow-up. Mean HOOS total score in the conventional straight stem group increased 36.3 points from 37.1 (95% CI 33.9 to 40.3) preoperatively to 73.4 (95% CI 70.3 to 76.4) at 3 months follow-up. 91.2% of patients remained blinded at 2 years follow-up. Both protocol adherence and follow-up success rate were 98%.
    Conclusions: Functional result at 3 months and 2 years after short stem THA is not superior to conventional cementless THA. There were more perioperative and postoperative complications in the short stem group. Direct comparison of two hip implants in a double-blinded randomised controlled trial is feasible.
    Trial registration number: NTR1560.
    MeSH term(s) Aged ; Arthroplasty, Replacement, Hip/adverse effects ; Arthroplasty, Replacement, Hip/methods ; Double-Blind Method ; Female ; Femur Neck/surgery ; Hip Joint/physiopathology ; Hip Joint/surgery ; Humans ; Male ; Middle Aged ; Osteoarthritis, Hip/surgery ; Postoperative Complications/epidemiology ; Prospective Studies ; Prosthesis Design ; Quality of Life ; Recovery of Function ; Severity of Illness Index ; Time Factors ; Treatment Outcome
    Language English
    Publishing date 2017-10-16
    Publishing country England
    Document type Comparative Study ; Journal Article ; Multicenter Study ; Randomized Controlled Trial
    ZDB-ID 2747269-3
    ISSN 2044-6055 ; 2044-6055 ; 2053-3624
    ISSN (online) 2044-6055
    ISSN 2044-6055 ; 2053-3624
    DOI 10.1136/bmjopen-2016-014522
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