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1.  Reliability and validity of the Dutch version of the foot and ankle outcome score (FAOS) 
Background
The Foot and Ankle Outcome Score (FAOS) is a patient-reported questionnaire measuring symptoms and functional limitations of the foot and ankle. Aim is to translate and culturally adapt the Dutch version of the FAOS and to investigate internal consistency, validity, repeatability and responsiveness.
Methods
According to the Cross Cultural Adaptation of Self-Report Measures guideline, the FAOS was translated into Dutch. Eighty-nine patients who had undergone an ankle arthroscopy, ankle arthrodesis, ankle ligament reconstruction or hallux valgus correction completed the FAOS, FFI, WOMAC and SF-36 questionnaires and were included in the validity study. Sixty-five of them completed the FAOS a second time to determine repeatability. Responsiveness was analysed in an additional 15 patients who were being treated for foot or ankle problems.
Results
Internal consistency of the FAOS is high (Cronbach’s alphas varying between 0.90 and 0.96). Repeatability can be considered good, with ICC’s ranging from 0.90 to 0.96. Construct validity can be classified as good with moderate-to-high correlations between the FAOS subscales and subscales of the FFI (0.55 to 0.90), WOMAC (0.57 to 0.92) and SF-36 subscales physical functioning, pain, social functioning and role-physical (0.33 to 0.81). Low standard response means were found for responsiveness (0.0 to 0.4).
Conclusions
The results of this study show that the Dutch version of the FAOS is a reliable and valid questionnaire to assess symptoms and functional limitations of the foot and ankle.
doi:10.1186/1471-2474-14-183
PMCID: PMC3681600  PMID: 23758917
Foot; Ankle; Questionnaire; FAOS; Dutch; Reliability; Validity; Orthopaedics
2.  The development of a comprehensive multidisciplinary care pathway for patients with a hip fracture: design and results of a clinical trial 
Background
Hip fractures frequently occur in older persons and severely decrease life expectancy and independence. Several care pathways have been developed to lower the risk of negative outcomes but most pathways are limited to only one aspect of care. The aim of this study was therefore to develop a comprehensive care pathway for older persons with a hip fracture and to conduct a preliminary analysis of its effect.
Methods
A comprehensive multidisciplinary care pathway for patients aged 60 years or older with a hip fracture was developed by a multidisciplinary team. The new care pathway was evaluated in a clinical trial with historical controls. The data of the intervention group were collected prospectively. The intervention group included all patients with a hip fracture who were admitted to University Medical Center Groningen between 1 July 2009 and 1 July 2011. The data of the control group were collected retrospectively. The control group comprised all patients with a hip fracture who were admitted between 1 January 2006 and 1 January 2008. The groups were compared with the independent sample t-test, the Mann–Whitney U-test or the Chi-squared test (Phi test). The effect of the intervention on fasting time and length of stay was adjusted by linear regression analysis for differences between the intervention and control group.
Results
The intervention group included 256 persons (women, 68%; mean age (SD), 78 (9) years) and the control group 145 persons (women, 72%; mean age (SD), 80 (10) years). Median preoperative fasting time and median length of hospital stay were significantly lower in the intervention group: 9 vs. 17 hours (p < 0.001), and 7 vs. 11 days (p < 0.001), respectively. A similar result was found after adjustment for age, gender, living condition and American Society of Anesthesiologists (ASA) classification. In-hospital mortality was also lower in the intervention group: 2% vs. 6% (p < 0.05). There were no statistically significant differences in other outcome measures.
Conclusions
The new comprehensive care pathway was associated with a significant decrease in preoperative fasting time and length of hospital stay.
doi:10.1186/1471-2474-15-188
PMCID: PMC4053577  PMID: 24885674
Care pathway; Elderly; Hip fracture; Fasting time; Length of stay
3.  The influence of computer-assisted surgery on rotational, coronal and sagittal alignment in revision total knee arthroplasty 
Background
Despite good results of primary total knee arthroplasty (TKA), the number of revision total knee arthroplasties (rTKAs) is rising. Proper implant position is essential, since malposition leads to worse clinical outcome. In rTKA most anatomical landmarks have disappeared because of extensive bone loss, making it more difficult to adequately implant the knee prosthesis. In primary TKA, computer-assisted surgery (CAS) leads to better prosthetic alignment than mechanical navigation guides. Literature about the use of CAS in rTKA is scarce though, and the effect on rotational prosthetic alignment has not been investigated yet. Hence the primary objective of this study is to compare rotational prosthetic alignment when using CAS in rTKA compared to a mechanical navigation guide. Secondary objectives are to compare prosthetic alignment in the coronal and sagittal planes. It is hypothesized that CAS leads to better rotational, coronal and sagittal prosthetic alignment when used during rTKA.
Methods/Design
A prospective clinical intervention study with use of a historical control group will be conducted. Forty-four patients with a minimum age of 18 to be admitted for CAS-rTKA between September 2012 and September 2015 will be included in the intervention group. Forty-four patients with a minimum age of 18 who underwent rTKA with the use of a mechanical navigation guide between January 2002 and April 2012 will form the historical control group. Both groups will be matched according to gender and type of revision prosthesis. Rotational prosthesis alignment will be evaluated using a CT-scan of the knee joint.
Discussion
Proper implant position is essential, since malposition leads to worse clinical outcome. Several studies show a significantly positive influence of CAS on prosthetic alignment in primary TKA, but literature about the use of CAS in rTKA is limited. The purpose of this study is thus to investigate the influence of CAS during rTKA on postoperative prosthetic alignment, compared to mechanical navigation guides.
Trial registration
Netherlands National Trial Register NTR3512
doi:10.1186/1471-2474-15-94
PMCID: PMC3995112  PMID: 24646028
4.  Evaluation of the effect of a comprehensive multidisciplinary care pathway for hip fractures: design of a controlled study 
Background
Hip fractures constitute an economic burden on healthcare resources. Most persons with a hip fracture undergo surgery. As morbidity and mortality rates are high, perioperative care leaves room for improvement. Improvement can be achieved if it is organized in comprehensive care pathways, but the effectiveness of these pathways is not yet clear. Hence the objective of this study is to compare the clinical effectiveness of a comprehensive care pathway with care as usual on self-reported limitations in Activities of Daily Living.
Methods/Design
A controlled trial will be conducted in which the comprehensive care pathway of University Medical Center Groningen will be compared with care as usual in two other, nonacademic, hospitals. In this trial, propensity scores will be used to adjust for differences at baseline between the intervention and control group. Propensity scores can be used in intervention studies where a classical randomized controlled trial is not feasible. Patients aged 60 years and older will be included. The hypothesis is that 15% more patients at University Medical Center Groningen compared with patients in the care-as-usual condition will have recovered at least as well at 6 months follow-up to pre-fracture levels for Activities of Daily Living.
Discussion
This study will yield new knowledge with respect to the clinical effectiveness of a comprehensive care pathway for the treatment of hip fractures. This is relevant because of the growing incidence of hip fractures and the consequent massive burden on the healthcare system. Additionally, this study will contribute to the growing knowledge of the application of propensity scores, a relatively novel statistical technique to simulate a randomized controlled trial in studies where it is not possible or difficult to execute this kind of design.
Trial registration
Nederlands Trial Register NTR3171
doi:10.1186/1471-2474-14-291
PMCID: PMC3815070  PMID: 24119130
Hip fracture; Care pathway; Propensity score; Elderly; Physical functioning
5.  Reliability and concurrent validity of the Dutch hip and knee replacement expectations surveys 
Background
Preoperative expectations of outcome of total hip and knee arthroplasty are important determinants of patients' satisfaction and functional outcome. Aims of the study were (1) to translate the Hospital for Special Surgery Hip Replacement Expectations Survey and Knee Replacement Expectations Survey into Dutch and (2) to study test-retest reliability and concurrent validity.
Methods
Patients scheduled for total hip (N = 112) or knee replacement (N = 101) were sent the Dutch Expectations Surveys twice with a 2 week interval to determine test-retest reliability. To determine concurrent validity, the Expectation WOMAC was sent.
Results
The results for the Dutch Hip Replacement Expectations Survey revealed good test-retest reliability (ICC 0.87), no bias and good internal consistency (alpha 0.86) (N = 72). The correlation between the Hip Expectations Score and the Expectation WOMAC score was 0.59 (N = 86). The results for the Dutch Knee Replacement Expectations Survey revealed good test-retest reliability (ICC 0.79), no bias and good internal consistency (alpha 0.91) (N = 46). The correlation with the Expectation WOMAC score was 0.52 (N = 57).
Conclusions
Both Dutch Expectations Surveys are reliable instruments to determine patients' expectations before total hip or knee arthroplasty. As for concurrent validity, the correlation between both surveys and the Expectation WOMAC was moderate confirming that the same construct was determined. However, patients scored systematically lower on the Expectation WOMAC compared to the Dutch Expectation Surveys. Research on patients' expectations before total hip and knee replacement has only been performed in a limited amount of countries. With the Dutch Expectations Surveys it is now possible to determine patients' expectations in another culture and healthcare setting.
doi:10.1186/1471-2474-11-242
PMCID: PMC2973929  PMID: 20958990
6.  Minimally invasive and computer-navigated total hip arthroplasty: a qualitative and systematic review of the literature 
Background
Both minimally invasive surgery (MIS) and computer-assisted surgery (CAS) for total hip arthroplasty (THA) have gained popularity in recent years. We conducted a qualitative and systematic review to assess the effectiveness of MIS, CAS and computer-assisted MIS for THA.
Methods
An extensive computerised literature search of PubMed, Medline, Embase and OVIDSP was conducted. Both randomised clinical trials and controlled clinical trials on the effectiveness of MIS, CAS and computer-assisted MIS for THA were included. Methodological quality was independently assessed by two reviewers. Effect estimates were calculated and a best-evidence synthesis was performed.
Results
Four high-quality and 14 medium-quality studies with MIS THA as study contrast, and three high-quality and four medium-quality studies with CAS THA as study contrast were included. No studies with computer-assisted MIS for THA as study contrast were identified. Strong evidence was found for a decrease in operative time and intraoperative blood loss for MIS THA, with no difference in complication rates and risk for acetabular outliers. Strong evidence exists that there is no difference in physical functioning, measured either by questionnaires or by gait analysis. Moderate evidence was found for a shorter length of hospital stay after MIS THA. Conflicting evidence was found for a positive effect of MIS THA on pain in the early postoperative period, but that effect diminished after three months postoperatively. Strong evidence was found for an increase in operative time for CAS THA, and limited evidence was found for a decrease in intraoperative blood loss. Furthermore, strong evidence was found for no difference in complication rates, as well as for a significantly lower risk for acetabular outliers.
Conclusions
The results indicate that MIS THA is a safe surgical procedure, without increases in operative time, blood loss, operative complication rates and component malposition rates. However, the beneficial effect of MIS THA on functional recovery has to be proven. The results also indicate that CAS THA, though resulting in an increase in operative time, may have a positive effect on operative blood loss and operative complication rates. More importantly, the use of CAS results in better positioning of acetabular component of the prosthesis.
doi:10.1186/1471-2474-11-92
PMCID: PMC2879237  PMID: 20470443
7.  Attentional and visual demands for sprint performance in non-fatigued and fatigued conditions: reliability of a repeated sprint test 
Background
Physical performance measures are widely used to assess physical function, providing information about physiological and biomechanical aspects of motor performance. However they do not provide insight into the attentional and visual demands for motor performance. A figure-of-eight sprint test was therefore developed to measure the attentional and visual demands for repeated-sprint performance. The aims of the study were: 1) to assess test-retest reliability of the figure-of-eight sprint test, and 2) to study the attentional and visual demands for sprint performance in a non-fatigued and fatigued condition.
Methods
Twenty-seven healthy athletes were included in the study. To determine test-retest reliability, a subgroup of 19 athletes performed the figure-of-eight sprint test twice. The figure-of-eight sprint test consisted of nine 30-second sprints. The sprint test consisted of three test parts: sprinting without any restriction, with an attention-demanding task, and with restricted vision. Increases in sprint times with the attention-demanding task or restricted vision are reflective of the attentional and visual demands for sprinting. Intraclass correlation coefficients (ICCs) and mean difference between test and retest with 95% confidence limits (CL) were used to assess test-retest reliability. Repeated-measures ANOVA were used for comparisons between the sprint times and fatigue measurements of the test parts in both a non-fatigued and fatigued condition.
Results
The figure-of-eight sprint test showed good test-retest reliability, with ICCs ranging from 0.75 to 0.94 (95% CL: 0.40-0.98). Zero lay within the 95% CL of the mean differences, indicating that no bias existed between sprint performance at test and retest. Sprint times during the test parts with attention-demanding task (P = 0.01) and restricted vision (P < 0.001) increased significantly compared to the base measurement. Furthermore the sprint times and fatigue measurements increased significantly in fatigued condition. There was a significant interaction effect between test part and level of fatigue (P = 0.03).
Conclusions
High ICCs and the absence of systematic variation indicate good test-retest reliability of the figure-of-eight sprint test. The attentional and visual demands for sprint performance, in both a non-fatigued and fatigued condition, can be measured in healthy team-sport athletes with the figure-of-eight sprint test.
doi:10.1186/1471-2474-11-84
PMCID: PMC3003243  PMID: 20438646
8.  The effects of exercise and weight loss in overweight patients with hip osteoarthritis: design of a prospective cohort study 
Background
Hip osteoarthritis (OA) is recognised as a substantial source of disability, with pain and loss of function as principal symptoms. An aging society and a growing number of overweight people, which is considered a risk factor for OA, contribute to the growing number of cases of hip OA. In knee OA patients, exercise as a single treatment is proven to be very effective towards counteracting pain and physical functionality, but the combination of weight loss and exercise is demonstrated to be even more effective. Exercise as a treatment for hip OA patients is also effective, however evidence is lacking for the combination of weight loss and exercise. Consequently, the aim of this study is to get a first impression of the potential effectiveness of exercise and weight loss in overweight patients suffering from hip OA.
Methods/Design
This is a prospective cohort study. Patients aged 25 or older, overweight (BMI > 25) or obese (BMI > 30), with clinical and radiographic evidence of OA of the hip and able to attend exercise sessions will be included. The intervention is an 8-month exercise and weight-loss lifestyle program. Main goal is to increase aerobic capacity, lose weight and stimulate a low-calorie and active lifestyle. Primary outcome is self-reported physical functioning. Secondary outcomes include pain, stiffness, health-related quality of life and habitual activity level. Weight loss in kilograms and percentage of fat-free mass will also be measured.
Discussion
The results of this study will give a first impression of potential effectiveness of exercise and weight loss as a combination program for patients with OA of the hip. Once this program is proven to be effective it may lead to postponing the moment of total hip replacement.
Trial Registration number
NTR1053
doi:10.1186/1471-2474-10-24
PMCID: PMC2649885  PMID: 19236692
9.  Reliability and validity of the short questionnaire to assess health-enhancing physical activity (SQUASH) in patients after total hip arthroplasty 
Background
Despite recognized benefits of regular physical activity on musculoskeletal fitness as well as general health, little is known about the physical activity behavior of patients after Total Hip Arthroplasty (THA). So far, no physical activity questionnaire has been validated in this category of patients. As the Short Questionnaire to Assess Health-enhancing physical activity (SQUASH) has been shown to be a fairly reliable and valid tool to gauge the physical activity behavior of the general Dutch adult population, we measured the reliability and relative validity of this tool in patients after THA.
Methods
44 patients (17 men and 27 women, mean age 71 ± 8 years) completed the SQUASH twice with an in-between period of 2 to 6 weeks (mean 3.7). Reliability was determined by calculating the Spearman correlation coefficient between the activity scores of the separate questions as well as the total activity scores from both administrations. Additionally, a Bland & Altman analysis was performed for the total activity scores. Relative validity was determined using the Actigraph™ accelerometer, worn by 39 patients (15 men and 24 women, mean age 70 ± 8 years) for a 2-week period following the second questionnaire, as a criterion measure.
Results
Spearman's correlation coefficient for overall reliability was 0.57. It varied between 0.45 and 0.90 for the separate questions. No systematic biases between readings were found. The Spearman correlation between Actigraph™ readings and total activity score was 0.67. It was 0.56 for total minutes of activity, 0.20 for time spent in light intensity activity, 0.40 for moderate activity and 0.35 for vigorous activity. Systematic bias was found between the SQUASH and the Actigraph™.
Conclusion
The SQUASH can be considered to be a fairly reliable tool to assess the physical activity behavior of patients after THA. Validity was found to be comparable with those of other questionnaires, and as it is short and easy to fill in, it may prove to be a useful tool to assess physical activity in this particular subset of the population. However, the considerable systematic bias found in this study illustrates the need for further analysis of the validity of the SQUASH.
doi:10.1186/1471-2474-9-141
PMCID: PMC2576250  PMID: 18928545
10.  A new interdisciplinary treatment strategy versus usual medical care for the treatment of subacromial impingement syndrome: a randomized controlled trial 
Background
Subacromial impingement syndrome (SIS) is the most frequently recorded shoulder disorder. When conservative treatment of SIS fails, a subacromial decompression is warranted. However, the best moment of referral for surgery is not well defined. Both early and late referrals have disadvantages – unnecessary operations and smaller improvements in shoulder function, respectively. This paper describes the design of a new interdisciplinary treatment strategy for SIS (TRANSIT), which comprises rules to treat SIS in primary care and a well-defined moment of referral for surgery.
Methods/Design
The effectiveness of an arthroscopic subacromial decompression versus usual medical care will be evaluated in a randomized controlled trial (RCT). Patients are eligible for inclusion when experiencing a recurrence of SIS within one year after a first episode of SIS which was successfully treated with a subacromial corticosteroid injection. After inclusion they will receive injection treatment again by their general practitioner. When, after this treatment, there is a second recurrence within a year post-injection, the participants will be randomized to either an arthroscopic subacromial decompression (intervention group) or continuation of usual medical care (control group). The latter will be performed by a general practitioner according to the Dutch National Guidelines for Shoulder Problems. At inclusion, at randomization and three, six and 12 months post-randomization an outcome assessment will take place. The primary outcome measure is the patient-reported Shoulder Disability Questionnaire. The secondary outcome measures include both disease-specific and generic measures, and an economic evaluation. Treatment effects will be compared for all measurement points by using a GLM repeated measures analyses.
Discussion
The rationale and design of an RCT comparing arthroscopic subacromial decompression with usual medical care for subacromial impingement syndrome are presented. The results of this study will improve insight into the best moment of referral for surgery for SIS.
doi:10.1186/1471-2474-8-15
PMCID: PMC1821022  PMID: 17316441
11.  Effectiveness of computer-navigated minimally invasive total hip surgery compared to conventional total hip arthroplasty: design of a randomized controlled trial 
Background
Moderate to severe osteoarthrosis is the most common indication for Total Hip Arthroplasty (THA). Minimally Invasive Total Hip Surgery (MIS) and computer-navigated surgery were introduced several years ago. However, the literature lacks well-designed studies that provide evidence of superiority of computer-navigated MIS over a conventional THA technique. Hence, the purpose of this study is to compare (cost)effectiveness of computer-navigated MIS with a conventional technique for THA. It is our hypothesis that computer-navigated MIS will lead to a quicker recovery during the early postoperative period (3 months), and to an outcome at least as good 6 months postoperatively. We also hypothesize that computer-navigated MIS leads to fewer perioperative complications and better prosthesis positioning. Furthermore, cost advantages of computer-navigated MIS over conventional THA technique are expected.
Methods/design
A cluster randomized controlled trial will be executed. Patients between the ages of 18 and 75 admitted for primary cementless unilateral THA will be included. Patients will be stratified using the Charnley classification. They will be randomly allocated to have computer-navigated MIS or conventional THA technique. Measurements take place preoperatively, perioperatively, and 6 weeks and 3 and 6 months postoperatively. Degree of limping (gait analysis), self-reported functional status and health-related quality of life (questionnaires) will be assessed preoperatively as well as postoperatively. Perioperative complications will be registered. Radiographic evaluation of prosthesis positioning will take place 6 weeks postoperatively. An evaluation of costs within and outside the healthcare sector will focus on differences in costs between computer-navigated MIS and conventional THA technique.
Discussion
Based on studies performed so far, few objective data quantifying the risks and benefits of computer-navigated MIS are available. Therefore, this study has been designed to compare (cost) effectiveness of computer-navigated MIS with a conventional technique for THA. The results of this trial will be presented as soon as they become available.
doi:10.1186/1471-2474-8-4
PMCID: PMC1781447  PMID: 17214906

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