Clinical Phenotypes in Persons With Hip Osteoarthritis and Prognostic Factors for Outcome After Total Hip Arthroplasty

Study Overview
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Brief Summary
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This prospective longitudinal cohort study aims (1) to identify clinical phenotypes in persons with hip osteoarthritis and after total hip arthroplasty, and (2) to identify prognostic factors for outcomes after total hip arthroplasty.

Detailed Description
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Osteoarthritis (OA) is one of the leading causes of pain and disability worldwide, with more than 300 million people currently affected by the disease. The hip joint is clinically one of the most affected locations of OA. Each year, more than 40 million prevalent cases and more than 2 million incident cases of hip OA are reported worldwide. The global prevalence and incidence of hip OA are expected to increase considerably in the upcoming decades, as a result of the aging population and an increasing prevalence of risk factors such as obesity and sedentary lifestyle. Since the population with hip OA is highly heterogeneous, individualized care pathways are needed instead of the current one-size-fits-all approach in clinical management. The identification of distinct subgroups within the population with hip OA might offer a foundation for individualized care pathways with the potential improvement of clinical outcomes. Therefore, the first aim of this longitudinal prospective cohort study is to identify clinical phenotypes in persons with hip osteoarthritis based on a set of contributing biopsychosocial variables, and to compare these phenotypes in terms of pain and disability before and after total hip arthroplasty (THA). Correspondingly with the increasing prevalence and incidence of hip OA, the mean utilization rate of hip implants per 100.000 inhabitants in Organisation for Economic Co-operation and Development (OECD) countries is expected to increase from 145 in 2010 to 275 in 2050. Annually, more than 30.000 THA's are performed in Belgium. This number is growing considerably, especially in younger, working-age patients. Total hip arthroplasty (THA) is a cost-effective procedure in patients with end-stage hip OA. However, previous studies have reported that 8% of patients are dissatisfied with the outcome, and up to 23% of patients report long-term pain after THA. Furthermore, over 30% of patients report activity limitations and about 25% of patients report participation restrictions after THA. An important step towards understanding and improving outcomes after THA is prognostic factor research. Therefore, the second aim of this clinical study is to identify prognostic factors for outcomes of pain and disability after THA in persons with hip OA. In this prospective longitudinal cohort study, 200 persons undergoing total hip arthroplasty for hip OA will be followed one-year post-surgery. Participants are recruited at the orthopaedic department of 'Ziekenhuis Oost-Limburg' in Genk and at 'de heuppraktijk' in Herselt. Participants will be assessed on a set of biopsychosocial variables, including pain-related fear-avoidance behavior, perceived injustice, psychopathology, traumatic experiences, social support, and self-efficacy. Furthermore, the somatosensory function will be assessed with thermal quantitative sensory testing (QST) and muscle strength will be assessed with a handheld dynamometer (MicroFet 2). Outcome measures include the Hip Disability and Osteoarthritis Outcome Score (HOOS), the OARSI recommended minimum core set of performance-based outcome measures (PBMs), the Patient-Specific Functional Scale (PSFS), Pain intensity (NPRS), Global Perceived Effect (GPE), and satisfaction (NRS). All these measurements will be performed before surgery, as well as 6 weeks, 3 months, and 12 months after surgery. Pain-related fear-avoidance behavior, perceived injustice, anxiety, depression, and pain will be assessed in the early postoperative phase.

Official Title
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Clinical Phenotypes in Persons With Hip Osteoarthritis and Prognostic Factors for Outcome After Total Hip Arthroplasty

Conditions
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Hip Osteoarthritis, Total Hip Arthroplasty

Intervention / Treatment
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* Procedure: Total Hip Arthroplasty


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Persons with a confirmed clinical or radiographic primary diagnosis of hip osteoarthritis who will undergo total hip arthroplasty (THA) Exclusion Criteria: Rheumatoid arthritis or other rheumatic diseases Another pathological condition explaining the symptoms (e.g. avascular necrosis) Neurological condition (e.g. Parkinson's disease, stroke...) significantly influencing the symptoms of hip osteoarthritis. Revision THA History of pathological fractures (e.g. osteoporosis, tumor...) Contralateral THA during follow-up period Total knee arthroplasty (TKA) during follow-up period Another surgery planned during follow-up period
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with hip osteoarthritis<br>Patients with hip osteoarthritis who will undergo total hip arthroplasty | Procedure: Total Hip Arthroplasty<br>* Direct Anterior Approach (DAA) Total Hip Arthroplasty (THA)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hip disability and Osteoarthritis Outcome Score (HOOS) | The HOOS is a self-reported questionnaire for evaluating symptoms and disability in patients with hip complaints. The questionnaire has been validated in Dutch and consists of 40 items, divided into five subscales: symptoms (5 items), pain (10 items), functioning in activities of daily living (ADL)(17 items), functioning in sport and recreation (4 items), and quality of life (4 items). Each question is scored on a 5-point Likert scale, in which a higher score reflects fewer complaints. A normalized score from 0 to 100 is calculated for the total scale, and for each subscale individually. | 1 week before THA | 
| Hip disability and Osteoarthritis Outcome Score (HOOS) | The HOOS is a self-reported questionnaire for evaluating symptoms and disability in patients with hip complaints. The questionnaire has been validated in Dutch and consists of 40 items, divided into five subscales: symptoms (5 items), pain (10 items), functioning in activities of daily living (ADL)(17 items), functioning in sport and recreation (4 items), and quality of life (4 items). Each question is scored on a 5-point Likert scale, in which a higher score reflects fewer complaints. A normalized score from 0 to 100 is calculated for the total scale, and for each subscale individually. | 6 weeks after THA | 
| Hip disability and Osteoarthritis Outcome Score (HOOS) | The HOOS is a self-reported questionnaire for evaluating symptoms and disability in patients with hip complaints. The questionnaire has been validated in Dutch and consists of 40 items, divided into five subscales: symptoms (5 items), pain (10 items), functioning in activities of daily living (ADL)(17 items), functioning in sport and recreation (4 items), and quality of life (4 items). Each question is scored on a 5-point Likert scale, in which a higher score reflects fewer complaints. A normalized score from 0 to 100 is calculated for the total scale, and for each subscale individually. | 3 months after THA | 
| Hip disability and Osteoarthritis Outcome Score (HOOS) | The HOOS is a self-reported questionnaire for evaluating symptoms and disability in patients with hip complaints. The questionnaire has been validated in Dutch and consists of 40 items, divided into five subscales: symptoms (5 items), pain (10 items), functioning in activities of daily living (ADL)(17 items), functioning in sport and recreation (4 items), and quality of life (4 items). Each question is scored on a 5-point Likert scale, in which a higher score reflects fewer complaints. A normalized score from 0 to 100 is calculated for the total scale, and for each subscale individually. | 12 months after THA | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Specific Functional Scale (PSFS) | The PSFS measures the functional status of the patient. The patient is asked to name the three most important activities for him that are difficult for him or which he is unable to perform because of his problems. Finally, the patient scores the degree of impairment in the activities on an 11-point NRS scale (0-10), where 0 stands for 'cannot perform the activity' and 10 'can perform the activity just as well as before occurrence of the problem'. | 1 week before THA | 
| Patient Specific Functional Scale (PSFS) | The PSFS measures the functional status of the patient. The patient is asked to name the three most important activities for him that are difficult for him or which he is unable to perform because of his problems. Finally, the patient scores the degree of impairment in the activities on an 11-point NRS scale (0-10), where 0 stands for 'cannot perform the activity' and 10 'can perform the activity just as well as before occurrence of the problem'. | 6 weeks after THA | 
| Patient Specific Functional Scale (PSFS) | The PSFS measures the functional status of the patient. The patient is asked to name the three most important activities for him that are difficult for him or which he is unable to perform because of his problems. Finally, the patient scores the degree of impairment in the activities on an 11-point NRS scale (0-10), where 0 stands for 'cannot perform the activity' and 10 'can perform the activity just as well as before occurrence of the problem'. | 3 months after THA | 
| Patient Specific Functional Scale (PSFS) | The PSFS measures the functional status of the patient. The patient is asked to name the three most important activities for him that are difficult for him or which he is unable to perform because of his problems. Finally, the patient scores the degree of impairment in the activities on an 11-point NRS scale (0-10), where 0 stands for 'cannot perform the activity' and 10 'can perform the activity just as well as before occurrence of the problem'. | 12 months after THA | 
| 36-Item Short Form Health Survey (SF-36) | The SF-36 is used to measure perceived health and health-related quality of life. The questionnaire has 36 items containing eight health-related categories: physical functioning, role limitations due to physical problems, role limitations due to emotional problems, pain, mental health, energy, general health perception, and social functioning. A high score corresponds to a better state of health. | 1 week before THA | 
| 36-Item Short Form Health Survey (SF-36) | The SF-36 is used to measure perceived health and health-related quality of life. The questionnaire has 36 items containing eight health-related categories: physical functioning, role limitations due to physical problems, role limitations due to emotional problems, pain, mental health, energy, general health perception, and social functioning. A high score corresponds to a better state of health. | 6 weeks after THA | 
| 36-Item Short Form Health Survey (SF-36) | The SF-36 is used to measure perceived health and health-related quality of life. The questionnaire has 36 items containing eight health-related categories: physical functioning, role limitations due to physical problems, role limitations due to emotional problems, pain, mental health, energy, general health perception, and social functioning. A high score corresponds to a better state of health. | 3 months after THA | 
| 36-Item Short Form Health Survey (SF-36) | The SF-36 is used to measure perceived health and health-related quality of life. The questionnaire has 36 items containing eight health-related categories: physical functioning, role limitations due to physical problems, role limitations due to emotional problems, pain, mental health, energy, general health perception, and social functioning. A high score corresponds to a better state of health. | 12 months after THA | 
| Global Perceived Effect (GPE) | The patient's opinion about recovery after THA will be measured using the Global Perceived Effect (GPE) score on a 7-point Likert scale, where 1 stands for a lot worse and 7 for a lot better. | 1 day after THA | 
| Global Perceived Effect (GPE) | The patient's opinion about recovery after THA will be measured using the Global Perceived Effect (GPE) score on a 7-point Likert scale, where 1 stands for a lot worse and 7 for a lot better. | 3 days after THA | 
| Global Perceived Effect (GPE) | The patient's opinion about recovery after THA will be measured using the Global Perceived Effect (GPE) score on a 7-point Likert scale, where 1 stands for a lot worse and 7 for a lot better. | 5 days after THA | 
| Global Perceived Effect (GPE) | The patient's opinion about recovery after THA will be measured using the Global Perceived Effect (GPE) score on a 7-point Likert scale, where 1 stands for a lot worse and 7 for a lot better. | 7 days after THA | 
| Global Perceived Effect (GPE) | The patient's opinion about recovery after THA will be measured using the Global Perceived Effect (GPE) score on a 7-point Likert scale, where 1 stands for a lot worse and 7 for a lot better. | 6 weeks after THA | 
| Global Perceived Effect (GPE) | The patient's opinion about recovery after THA will be measured using the Global Perceived Effect (GPE) score on a 7-point Likert scale, where 1 stands for a lot worse and 7 for a lot better. | 3 months after THA | 
| Global Perceived Effect (GPE) | The patient's opinion about recovery after THA will be measured using the Global Perceived Effect (GPE) score on a 7-point Likert scale, where 1 stands for a lot worse and 7 for a lot better. | 12 months after THA | 
| Numerical Rating Scale (NRS) of Patient Satisfaction | Patient satisfaction will be measured on an 11-point Numerical Rating Scale (NRS), where 0 stands for no pain and 10 for worst imaginable pain. | 1 day after THA | 
| Numerical Rating Scale (NRS) of Patient Satisfaction | Patient satisfaction will be measured on an 11-point Numerical Rating Scale (NRS), where 0 stands for no pain and 10 for worst imaginable pain. | 3 days after THA | 
| Numerical Rating Scale (NRS) of Patient Satisfaction | Patient satisfaction will be measured on an 11-point Numerical Rating Scale (NRS), where 0 stands for no pain and 10 for worst imaginable pain. | 5 days after THA | 
| Numerical Rating Scale (NRS) of Patient Satisfaction | Patient satisfaction will be measured on an 11-point Numerical Rating Scale (NRS), where 0 stands for no pain and 10 for worst imaginable pain. | 7 days after THA | 
| Numerical Rating Scale (NRS) of Patient Satisfaction | Patient satisfaction will be measured on an 11-point Numerical Rating Scale (NRS), where 0 stands for no pain and 10 for worst imaginable pain. | 6 weeks after THA | 
| Numerical Rating Scale (NRS) of Patient Satisfaction | Patient satisfaction will be measured on an 11-point Numerical Rating Scale (NRS), where 0 stands for no pain and 10 for worst imaginable pain. | 3 months after THA | 
| Numerical Rating Scale (NRS) of Patient Satisfaction | Patient satisfaction will be measured on an 11-point Numerical Rating Scale (NRS), where 0 stands for no pain and 10 for worst imaginable pain. | 12 months after THA | 
| Numerical Pain Rating Scale (NPRS) | Average pain intensity last week and pain intensity at the moment will be measured on an 11-point Numerical Pain Rating Scale (NPRS), where 0 stands for no pain and 10 for worst imaginable pain. | 1 week before THA | 
| Numerical Pain Rating Scale (NPRS) | Average pain intensity last week and pain intensity at the moment will be measured on an 11-point Numerical Pain Rating Scale (NPRS), where 0 stands for no pain and 10 for worst imaginable pain. | 1 day after THA | 
| Numerical Pain Rating Scale (NPRS) | Average pain intensity last week and pain intensity at the moment will be measured on an 11-point Numerical Pain Rating Scale (NPRS), where 0 stands for no pain and 10 for worst imaginable pain. | 3 days after THA | 
| Numerical Pain Rating Scale (NPRS) | Average pain intensity last week and pain intensity at the moment will be measured on an 11-point Numerical Pain Rating Scale (NPRS), where 0 stands for no pain and 10 for worst imaginable pain. | 5 days after THA | 
| Numerical Pain Rating Scale (NPRS) | Average pain intensity last week and pain intensity at the moment will be measured on an 11-point Numerical Pain Rating Scale (NPRS), where 0 stands for no pain and 10 for worst imaginable pain. | 7 days after THA | 
| Numerical Pain Rating Scale (NPRS) | Average pain intensity last week and pain intensity at the moment will be measured on an 11-point Numerical Pain Rating Scale (NPRS), where 0 stands for no pain and 10 for worst imaginable pain. | 6 weeks after THA | 
| Numerical Pain Rating Scale (NPRS) | Average pain intensity last week and pain intensity at the moment will be measured on an 11-point Numerical Pain Rating Scale (NPRS), where 0 stands for no pain and 10 for worst imaginable pain. | 3 months after THA | 
| Numerical Pain Rating Scale (NPRS) | Average pain intensity last week and pain intensity at the moment will be measured on an 11-point Numerical Pain Rating Scale (NPRS), where 0 stands for no pain and 10 for worst imaginable pain. | 12 months after THA | 
| 30-second Chair Stand Test | The 30-second Chair Stand Test will be used to assess sit-to-stand activity (physical function). The maximum number of chair stand repetitions within 30 seconds will be used as the outcome value. Movement quality during the performance-based tests is assessed based on acceleration data measured with an Inertial Measurement Unit (IMU). | 1 week before THA | 
| 30-second Chair Stand Test | The 30-second Chair Stand Test will be used to assess sit-to-stand activity (physical function). The maximum number of chair stand repetitions within 30 seconds will be used as the outcome value. Movement quality during the performance-based tests is assessed based on acceleration data measured with an Inertial Measurement Unit (IMU). | 6 weeks after THA | 
| 30-second Chair Stand Test | The 30-second Chair Stand Test will be used to assess sit-to-stand activity (physical function). The maximum number of chair stand repetitions within 30 seconds will be used as the outcome value. Movement quality during the performance-based tests is assessed based on acceleration data measured with an Inertial Measurement Unit (IMU). | 3 months after THA | 
| 30-second Chair Stand Test | The 30-second Chair Stand Test will be used to assess sit-to-stand activity (physical function). The maximum number of chair stand repetitions within 30 seconds will be used as the outcome value. Movement quality during the performance-based tests is assessed based on acceleration data measured with an Inertial Measurement Unit (IMU). | 12 months after THA | 
| 11-step Stair Climb Test | The 11-step Stair Climb Test will be used to assess ascending and descending stair activity (physical function). The time in seconds to ascend and descend 11 stairs will be used as the outcome value. Movement quality during the performance-based tests is assessed based on acceleration data measured with an Inertial Measurement Unit (IMU). | 1 week before THA | 
| 11-step Stair Climb Test | The 11-step Stair Climb Test will be used to assess ascending and descending stair activity (physical function). The time in seconds to ascend and descend 11 stairs will be used as the outcome value. Movement quality during the performance-based tests is assessed based on acceleration data measured with an Inertial Measurement Unit (IMU). | 6 weeks after THA | 
| 11-step Stair Climb Test | The 11-step Stair Climb Test will be used to assess ascending and descending stair activity (physical function). The time in seconds to ascend and descend 11 stairs will be used as the outcome value. Movement quality during the performance-based tests is assessed based on acceleration data measured with an Inertial Measurement Unit (IMU). | 3 months after THA | 
| 11-step Stair Climb Test | The 11-step Stair Climb Test will be used to assess ascending and descending stair activity (physical function). The time in seconds to ascend and descend 11 stairs will be used as the outcome value. Movement quality during the performance-based tests is assessed based on acceleration data measured with an Inertial Measurement Unit (IMU). | 12 months after THA | 
| 40-meter (4x10-meter) Fast Paced Walk Test | The 40-meter (4x10-meter) Fast Paced Walk Test will be used to assess short distance walking activity (physical function). The time in seconds to walk 4 x 10 meters for a total of 40 meters will be used as the outcome value. Movement quality during the performance-based tests is assessed based on acceleration data measured with an Inertial Measurement Unit (IMU). | 1 week before THA | 
| 40-meter (4x10-meter) Fast Paced Walk Test | The 40-meter (4x10-meter) Fast Paced Walk Test will be used to assess short distance walking activity (physical function). The time in seconds to walk 4 x 10 meters for a total of 40 meters will be used as the outcome value. Movement quality during the performance-based tests is assessed based on acceleration data measured with an Inertial Measurement Unit (IMU). | 6 weeks after THA | 
| 40-meter (4x10-meter) Fast Paced Walk Test | The 40-meter (4x10-meter) Fast Paced Walk Test will be used to assess short distance walking activity (physical function). The time in seconds to walk 4 x 10 meters for a total of 40 meters will be used as the outcome value. Movement quality during the performance-based tests is assessed based on acceleration data measured with an Inertial Measurement Unit (IMU). | 3 months after THA | 
| 40-meter (4x10-meter) Fast Paced Walk Test | The 40-meter (4x10-meter) Fast Paced Walk Test will be used to assess short distance walking activity (physical function). The time in seconds to walk 4 x 10 meters for a total of 40 meters will be used as the outcome value. Movement quality during the performance-based tests is assessed based on acceleration data measured with an Inertial Measurement Unit (IMU). | 12 months after THA | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hip Osteoarthritis, Total Hip Arthroplasty, Prognostic factors, Pain, Disability, Psychotraumatic events, Fear-Avoidance, Self-efficacy, Perceived Injustice, Quantitative Sensory Testing, Clinical phenotype, Psychopathology