Background
Methods/design
CONSORT
Ethical principles
Study design
Study population
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Patients < 65 years of age
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Debilitating knee osteoarthritis with an indication for KA, but not yet operated
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Currently participating in a job (either paid or voluntary)
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Able to perform usual rehabilitation care
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Cognitive or mental impairment
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No adequate levels of reading and writing the Dutch language
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Any disabling condition apart from knee osteoarthritis that restricts patients from performing their normal activities (e.g. pulmonary or cardiac disease, systemic inflammatory disease or pre-existing arthroplasty of hip or contralateral knee)
Sample size
Recruitment
Randomization and allocation concealment
Intervention
Usual care physiotherapy rehabilitation
Training of intervention physiotherapists performing GAS rehabilitation
Data collection
Outcome measures
Intervention group | Control group | |||||||
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Pre-operative | 3 months | 6 months | 12 months | Preoperative | 3 months | 6 months | 12 months | |
PROMs | ||||||||
- VASa | X | X | X | X | X | X | X | X |
- KOOS | X | X | X | X | X | X | X | X |
- OKS (-APQ) | X | X | X | X | X | X | X | X |
- SQUASH | X | X | X | X | X | X | X | X |
- WORQ | X | X | X | X | X | X | X | X |
- HADS | X | X | X | X | ||||
- PAM | X | X | X | X | ||||
- NPS | X | X | X | X | X | X | ||
- PT evaluationb | X | X | X | X | X | X | ||
Performance measures | ||||||||
- Activ8® | X | X | X | X | ||||
- GAS scores | X | X | X |
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The Knee injury and Osteoarthritis Outcome Score (KOOS) is a knee-specific questionnaire designed to assess symptoms and knee function in a young, physically active patient with knee damage and knee OA [25, 26]. It comprises five subscales (pain, other symptoms, function in daily living, function in sport and recreation, and knee-related quality of life) with a total of 42 questions. Standardized answering options are given (5-point Likert boxes) and each question is assigned a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale.
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The Oxford Knee Score Activity and Participation Questionnaire supplement (OKS-APQ) is a supplement to the original OKS, developed to assess higher levels of activity and participation in younger and more active KA patients [27]. It contains eight extra questions, making 20 in all, on patients’ perspective concerning pain and function of the knee after KA [27‐29]. Standardized answer options are given (5-point Likert boxes) and each question is assigned a score from 0 to 4. The sum of items results in a 0 – 48 score with 0 being the best score and 48 the worst.
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The Short QUestionnaire to ASsess Health-enhancing physical activity (SQUASH) is a self-reported questionnaire comprising questions on (A) daily living activities; (B) activities at work and school; (C) household activities; and (D) leisure time activities [30]. Questions concerning the frequency, duration and intensity of the performed activities are asked, and the number of minutes spent on each activity are totalled. A calculation can then be made to determine whether patients meet the Dutch Recommendation for Health-Enhancing Physical Activity (NNGB) [31]. In the Netherlands, the SQUASH is currently the standard instrument used to assess the physical activity level in the general Dutch population.
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The Work, Osteoarthritis or joint-Replacement Questionnaire (WORQ) was developed to assess physical difficulty experienced in work before or following TKA [32]. The questionnaire comprises 13 physical activities and patients are asked to grade the difficulty they have performing these activities on a five-point scale: none, mild, moderate, severe or extreme difficulty, corresponding with the scores 4, 3, 2, 1 and 0 respectively. The sum of the items is converted to a 0 – 100 score, with 100 being the best score and zero the worst.
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The Net Promotor Score (NPS) is a single question asking patients how likely it is that they would recommend their operation (KA) to friends or family [33]. It is a 0 – 10 point scale with zero representing very unlikely and ten very likely. Responses are divided into three groups: 10 – 9 are ‘promotors’, 8 – 7 are ‘passives’ and 6 – 0 are ‘detractors’. The overall score is then calculated by subtracting the percentage of detractors from the percentage of promotors, resulting in a score between -100 and +100.
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The Patient Activation Measure (PAM) is a non-knee-specific questionnaire for measuring the level of patient self-management concerning their health [34]. It contains 13 items and asks patients about their beliefs, knowledge and confidence concerning their engagement in a wide range of health behaviours. It assigns an activation score ranging from 0 to 100, based on the responses to the 13-item scale, with 100 representing the highest level of self-management.
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The Hospital Anxiety and Depression Scale (HADS) is a 14-item scale containing seven questions that relate to anxiety and seven questions that relate to depression [35, 36]. Each item is rated on a four-point scale ranging from 0 (not at all) to 3 (very often). Responses are based on the relative frequency of symptoms over the preceding week. Possible scores range from 0 to 21 for each subscale, with 0 meaning no symptoms and 21 meaning severe symptoms.
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Physiotherapy evaluation questions will be asked on topics such as the average duration and frequency of PT sessions, location of physiotherapy and patients’ satisfaction concerning their PT treatment.
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The Activ8® activity monitor is a newly designed, recently validated accelerometer that measures acceleration in three planes (3D) (Horemans et al, The Activ8 Activity Monitor: validation of detection of body postures and movements, submitted). It is a small device (2×3cm) that can be fixed with Tegaderm™ waterproof transparent dressing on the ventral side of the upper leg, halfway between hip and knee. This allows patients to take a shower while wearing the Activ8®. Patients will wear the Activ8® continuously for one week +/- 1 month preoperatively and continuously for one week 6 months postoperatively.
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GAS scores will be collected for patients in the intervention group at three and six months postoperatively.