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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.  Cross-cultural adaptation and reliability and validity of the Dutch Patient-Rated Tennis Elbow Evaluation (PRTEE-D) 
Background
Lateral Epicondylalgia (LE) is a common injury for which no reliable and valid measure exists to determine severity in the Dutch language. The Patient-Rated Tennis Elbow Evaluation (PRTEE) is the first questionnaire specifically designed for LE but in English. The aim of this study was to translate into Dutch and cross-culturally adapt the PRTEE and determine reliability and validity of the PRTEE-D (Dutch version).
Methods
The PRTEE was cross-culturally adapted according to international guidelines. Participants (n = 122) were asked to fill out the PRTEE-D twice with a one week interval to assess test-retest reliability. Internal consistency of the PRTEE-D was determined by calculating Crohnbach’s alphas for the questionnaire and subscales. Intraclass Correlation Coefficients (ICC) were calculated for the overall PRTEE-D score, pain and function subscale and individual questions to determine test-retest reliability. Additionally, the Disabilities for the Arm, Shoulder and Hand questionnaire (DASH) and Visual Analogue Scale (VAS) pain scores were obtained from 30 patients to assess construct validity; Spearman’s correlation coefficients were calculated between the PRTEE-D (subscales) and DASH and VAS-pain scores.
Results
The PRTEE was successfully cross-culturally adapted into Dutch (PRTEE-D). Crohnbach’s alpha for the first assessment of the PRTEE-D was 0.98; Crohnbach’s alpha was 0.93 for the pain subscale and 0.97 for the function subscale. ICC for the PRTEE-D was 0.98; subscales also showed excellent ICC values (pain scale 0.97 and function scale 0.97). A significant moderate correlation exists between PRTEE-D and DASH (0.65) and PRTEE-D and VAS pain (0.68).
Conclusion
The PRTEE was successfully cross-culturally adapted and this study showed that the PRTEE-D is reliable and valid to obtain an indication of severity of LE. An easy-to-use instrument for practitioners is now available and this facilitates comparing Dutch and international research data.
Electronic supplementary material
The online version of this article (doi:10.1186/1471-2474-15-270) contains supplementary material, which is available to authorized users.
doi:10.1186/1471-2474-15-270
PMCID: PMC4243580  PMID: 25112272
Arm injuries; Tennis elbow; Tendon; Tendinopathy; Lateral epicondylitis; PRTEE; PRFEQ
3.  Wear, bone density, functional outcome and survival in vitamin E-incorporated polyethylene cups in reversed hybrid total hip arthroplasty: design of a randomized controlled trial 
Background
Aseptic loosening of total hip arthroplasties is generally caused by periprosthetic bone resorption due to tissue reactions on polyethylene wear particles. In vitro testing of polyethylene cups incorporated with vitamin E shows increased wear resistance. The objective of this study is to compare vitamin E-stabilized highly cross-linked polyethylene with conventional cross-linked polyethylene in “reversed hybrid” total hip arthroplasties (cemented all-polyethylene cups combined with uncemented femoral stems). We hypothesize that the adjunction of vitamin E leads to a decrease in polyethylene wear in the long-term. We also expect changes in bone mineral density, less osteolysis, equal functional scores and increased implant survival in polyethylene cemented cups incorporated with vitamin E in the long-term.
Design
A double-blinded randomized controlled trial will be conducted. Patients to be included are aged under 70, suffer from non-inflammatory degenerative joint disease of the hip and are scheduled for a primary total hip arthroplasty. The study group will receive a reversed hybrid total hip arthroplasty with a vitamin E-stabilized highly cross-linked polyethylene cemented cup. The control group will receive a reversed hybrid total hip arthroplasty with a conventional cross-linked polyethylene cemented cup. Radiological follow-up will be assessed at 6 weeks and at 1, 3, 5, 7 and 10 years postoperatively, to determine polyethylene wear and osteolysis. Patient-reported functional status (HOOS), physician-reported functional status (Harris Hip Score) and patients’ physical activity behavior (SQUASH) will also be assessed at these intervals. Acetabular bone mineral density will be assessed by dual energy X-ray absorptiometry (DEXA) at 6 weeks and at 1 year and 2 years postoperatively. Implant survival will be determined at 10 years postoperatively.
Discussion
In vitro results of vitamin E-stabilized polyethylene are promising, showing increased wear resistance. However, controlled clinical follow-up data are not available at this moment.
This randomized controlled trial has been designed to determine wear, bone mineral density, functional outcome and survival in reversed hybrid total hip arthroplasty comparing cemented vitamin E-stabilized highly cross-linked polyethylene cups with cemented conventional cross-linked polyethylene cups.
Trial registration
Dutch Trial Registry NTR3049
doi:10.1186/1471-2474-13-178
PMCID: PMC3517763  PMID: 22994935
4.  Hemiarthroplasty versus angle-stable locking compression plate osteosynthesis in the treatment of three- and four-part fractures of the proximal humerus in the elderly: design of a randomized controlled trial 
Background
The optimal surgical management of dislocated three- and four-part fractures of the proximal humerus in elderly patients remains unclear. Most used techniques are hemiarthroplasty and angle-stable locking compression plate osteosynthesis. In the current literature there is no evidence available presenting superior results between hemiarthroplasty and angle-stable locking compression plate osteosynthesis in terms of speed of recovery, pain, patient satisfaction, functional outcome, quality of life or complications.
Methods/Design
A randomized controlled multicenter trial will be conducted. Patients older than 60 years of age with a dislocated three- or four-part fracture of the proximal humerus as diagnosed by X-rays and CT-scans will be included. Exclusion criteria are a fracture older than 14 days, multiple comorbidity, multitrauma, a pathological fracture, previous surgery on the injured shoulder, severely deranged function caused by a previous disease, "head-split" proximal humerus fracture and unwillingness or inability to follow instructions. Participants will be randomized between surgical treatment with hemiarthroplasty and angle-stable locking compression plate osteosynthesis. Measurements will take place preoperatively and 3 months, 6 months, 9 months, 12 months and 24 months postoperatively. Primary outcome measure is speed of recovery of functional capacity of the affected upper limb using the Disabilities of Arm, Shoulder and Hand score (DASH). Secondary outcome measures are pain, patient satisfaction, shoulder function, quality of life, radiological evaluation and complications. Data will be analyzed on an intention-to-treat basis, using univariate and multivariate analyses.
Discussion
Both hemiarthroplasty and angle-stable locking compression plate osteosynthesis are used in the current treatment of dislocated three-and four-part fractures of the proximal humerus. There is a lack of level-1 studies comparing these two most-used surgical treatment options. This randomized controlled multicenter trial has been designed to determine which surgical treatment option provides the fastest recovery of functional capacity of the affected upper limb, and will provide better outcomes in pain, satisfaction, shoulder function, quality of life, radiological evaluation and complications.
Trial registration number
The trial is registered in the Netherlands Trial Registry (NTR2461)
doi:10.1186/1471-2474-13-16
PMCID: PMC3299658  PMID: 22321162
5.  The TOPSHOCK study: Effectiveness of radial shockwave therapy compared to focused shockwave therapy for treating patellar tendinopath - design of a randomised controlled trial 
Background
Patellar tendinopathy is a chronic overuse injury of the patellar tendon that is especially prevalent in people who are involved in jumping activities. Extracorporeal Shockwave Therapy is a relatively new treatment modality for tendinopathies. It seems to be a safe and promising part of the rehabilitation program for patellar tendinopathy. Extracorporeal Shockwave Therapy originally used focused shockwaves. Several years ago a new kind of shockwave therapy was introduced: radial shockwave therapy. Studies that investigate the effectiveness of radial shockwave therapy as treatment for patellar tendinopathy are scarce. Therefore the aim of this study is to compare the effectiveness of focussed shockwave therapy and radial shockwave therapy as treatments for patellar tendinopathy.
Methods/design
The TOPSHOCK study (Tendinopathy Of Patella SHOCKwave) is a two-armed randomised controlled trial in which the effectiveness of focussed shockwave therapy and radial shockwave therapy are directly compared. Outcome assessors and patients are blinded as to which treatment is given. Patients undergo three sessions of either focused shockwave therapy or radial shockwave therapy at 1-week intervals, both in combination with eccentric decline squat training. Follow-up measurements are scheduled just before treatments 2 and 3, and 1, 4, 7 and 12 weeks after the final treatment. The main outcome measure is the Dutch VISA-P questionnaire, which asks for pain, function and sports participation in subjects with patellar tendinopathy. Secondary outcome measures are pain determined with a VAS during ADL, sports and decline squats, rating of subjective improvement and overall satisfaction with the treatment. Patients will also record their sports activities, pain during and after these activities, and concurrent medical treatment on a weekly basis in a web-based diary. Results will be analysed according to the intention-to-treat principle.
Discussion
The TOPSHOCK study is the first randomised controlled trial that directly compares the effectiveness of focused shockwave therapy and radial shockwave therapy, both in combination with eccentric decline squat training, for treating patellar tendinopathy.
Trial registration
Trial registration number NTR2774.
doi:10.1186/1471-2474-12-229
PMCID: PMC3212818  PMID: 21989041
6.  Clinical and radiological outcome of conservative vs. surgical treatment of atraumatic degenerative rotator cuff rupture: design of a randomized controlled trial 
Background
Subacromial impingement syndrome is a frequently observed disorder in orthopedic practice. Lasting symptoms and impairment may occur when a subsequent atraumatic rotator cuff rupture is also present. However, degenerative ruptures of the rotator cuff can also be observed in asymptomatic elderly individuals. Treatment of these symptomatic degenerative ruptures may be conservative or surgical. Acceptable results are reported for both treatment modalities. No evidence-based level-1 studies have been conducted so far to compare these treatment modalities. The objective of this study is to determine whether there is a difference in outcome between surgical reconstruction and conservative treatment of a degenerative atraumatic rotator cuff tendon rupture.
Methods/Design
A randomized controlled trial will be conducted. Patients aged between 45 and 75 with a symptomatic atraumatic rotator cuff rupture as diagnosed by MRI will be included. Exclusion criteria are traumatic rotator cuff rupture, frozen shoulder and diabetes mellitus. Patients will be randomized into two groups. Conservative treatment includes physical therapy according to a standardized protocol, NSAIDs and, if indicated, subacromial infiltration with a local anesthetic and corticosteroids. Surgical reconstruction is performed under general anesthesia in combination with an interscalenus plexus block. An acromioplasty with reconstruction of the rotator cuff tendon is performed, as described by Rockwood et al. Measurements take place preoperatively and 6 weeks, 3 months, 6 months and 1 year postoperatively. The primary outcome measure is the Constant score. Secondary measures include both disease-specific and generic outcome measures, and an economic evaluation. Additionally, one year after inclusion a second MRI will be taken of all patients in order to determine whether extent and localization of the rupture as well as the amount of fatty degeneration are prognostic factors.
Discussion
Both surgical as conservative treatment of a symptomatic atraumatic rotator cuff tendon rupture is used in current practice. There is a lack of level-1 studies comparing surgical vs. conservative treatment. This randomized controlled trial has been designed to determine whether the surgical treatment of a degenerative atraumatic rotator cuff tendon rupture may lead to a better functional and radiological outcome than conservative treatment after one year of follow-up.
Trial registration number
Netherlands Trial Register (NTR): NTRTC2343
doi:10.1186/1471-2474-12-25
PMCID: PMC3057192  PMID: 21269421
7.  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
8.  The TOPGAME-study: effectiveness of extracorporeal shockwave therapy in jumping athletes with patellar tendinopathy. Design of a randomised controlled trial 
Background
Patellar tendinopathy is a major problem for many athletes, especially those involved in jumping activities. Despite its frequency and negative impact on athletic careers, no evidence-based guidelines for management of this overuse injury exist. Since functional outcomes of conservative and surgical treatments remain suboptimal, new diagnostic and therapeutic strategies have to be developed and evaluated.
Extracorporeal shockwave therapy (ESWT) appears to be a promising treatment in patients with chronic patellar tendinopathy. ESWT is most often applied after the known conservative treatments have failed. However, its effectiveness as primary therapy has not been studied in athletes who keep playing sports despite having patellar tendon pain.
The aim of this study is to determine the effectiveness of ESWT in athletes with patellar tendinopathy who are still in training and competition.
Methods/design
The TOPGAME-study (Tendinopathy of Patella Groningen Amsterdam Maastricht ESWT) is a multicentre two-armed randomised controlled trial with blinded participants and outcome assessors, in which the effectiveness of patient-guided focussed ESWT treatment (compared to placebo ESWT) on pain reduction and recovery of function in athletes with patellar tendinopathy will be investigated. Participants are volleyball, handball and basketball players with symptoms of patellar tendinopathy for a minimum of 3 to a maximum duration of 12 months who are still able to train and compete. The intervention group receives three patient-guided focussed medium-energy density ESWT treatments without local anaesthesia at a weekly interval in the first half of the competition. The control group receives placebo treatment. The follow-up measurements take place 1, 12 and 22 weeks after the final ESWT or placebo treatment, when athletes are still in competition. Primary outcome measure is the VISA-P (Victorian Institute of Sport Assessment - patella) score. Data with regard to pain during function tests (jump tests and single-leg decline squat) and ultrasound characteristics are also collected. During the follow-up period participants also register pain, symptoms, sports participation, side effects of treatment and additional medical consumption in an internet-based diary.
Discussion
The TOPGAME-study is the first RCT to study the effectiveness of patient-guided ESWT in athletes with patellar tendinopathy who are still in training and competition.
Trial registration
Trial registration number NTR1408.
doi:10.1186/1471-2474-11-28
PMCID: PMC2831826  PMID: 20144188
9.  Retention of the posterior cruciate ligament versus the posterior stabilized design in total knee arthroplasty: a prospective randomized controlled clinical trial 
Background
Prosthetic design for the use in primary total knee arthroplasty has evolved into designs that preserve the posterior cruciate ligament (PCL) and those in which the ligament is routinely sacrificed (posterior stabilized). In patients with a functional PCL the decision which design is chosen depends largely on the favour and training of the surgeon.
The objective of this study is to determine whether the patient's perceived outcome and speed of recovery differs between a posterior cruciate retaining total knee arthroplasty and a posterior stabilized total knee arthroplasty.
Methods/Design
A randomized controlled trial will be conducted. Patients who are admitted for primary unilateral TKA due to primary osteoarthrosis are included when the following inclusion criteria are met: non-fixed fixed varus or valgus deformity less than 10 degrees, age between 55 and 85 years, body mass index less than 35 kg/m2 and ASA score (American Society of Anaesthesiologists) I or II. Patients are randomized in 2 groups. Patients in the posterior cruciate retaining group will receive a prosthesis with a posterior cut-out for the posterior cruciate ligament and relatively flat topography. In patients allocated to the posterior stabilized group, in which the posterior cruciate ligament is excised, the design may substitute for this function by an intercondylar tibial prominence that articulates with the femur in flexion. Measurements will take place preoperatively and 6 weeks, 3 months, 6 months and 1 year postoperatively.
At all measurement points patient's perceived outcome will be assessed using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC). Secondary outcome measures are quality of life (SF-36) and physician reported functional status and range of motion as determined with the Knee Society Clinical Rating System (KSS).
Discussion
In the current practice both posterior cruciate retaining and posterior stabilized designs for total knee arthroplasty are being used. To date no studies have been performed determining whether there is a difference in patient's perceived outcome between the two designs. Additionally, there is a lack of studies determining the speed of recovery in both designs as most studies only determine the final outcome. This randomised controlled study has been designed to determine whether the patient's perceived outcome and speed of recovery differs between a posterior cruciate retaining total knee arthroplasty and a posterior stabilized total knee arthroplasty.
Trial Registration
The trial is registered in the Netherlands Trial Registry (NTR1673).
doi:10.1186/1471-2474-10-119
PMCID: PMC2761294  PMID: 19793397
10.  Validity and reliability of the Dutch translation of the VISA-P questionnaire for patellar tendinopathy 
Background
The VISA-P questionnaire evaluates severity of symptoms, knee function and ability to play sports in athletes with patellar tendinopathy. This English-language self-administered brief patient outcome score was developed in Australia to monitor rehabilitation and to evaluate outcome of clinical studies. Aim of this study was to translate the questionnaire into Dutch and to study the reliability and validity of the Dutch version of the VISA-P.
Methods
The questionnaire was translated into Dutch according to internationally recommended guidelines. Test-retest reliability was determined in 99 students with a time interval of 2.5 weeks. To determine discriminative validity of the Dutch VISA-P, 18 healthy students, 15 competitive volleyball players (at-risk population), 14 patients with patellar tendinopathy, 6 patients who had surgery for patellar tendinopathy, 17 patients with knee injuries other than patellar tendinopathy, and 9 patients with symptoms unrelated to their knees completed the Dutch VISA-P.
Results
The Dutch VISA-P questionnaire showed satisfactory test-retest reliability (ICC = 0.74). The mean (± SD) VISA-P scores were 95 (± 9) for the healthy students, 89 (± 11) for the volleyball players, 58 (± 19) for patients with patellar tendinopathy, and 56 (± 21) for athletes who had surgery for patellar tendinopathy. Patients with other knee injuries or symptoms unrelated to the knee scored 62 (± 24) and 77 (± 24).
Conclusion
The translated Dutch version of the VISA-P questionnaire is equivalent to its original version, has satisfactory test-retest reliability and is a valid score to evaluate symptoms, knee function and ability to play sports of Dutch athletes with patellar tendinopathy.
doi:10.1186/1471-2474-10-102
PMCID: PMC2734752  PMID: 19671174
11.  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
12.  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

Results 1-12 (12)