Hip OsteoarthritisHIPPROCLIPSNCT05265858
Clinical Phenotypes in Persons With Hip Osteoarthritis and Prognostic Factors for Outcome After Total Hip Arthroplasty
An observational study of Hip Osteoarthritis and Total Hip Arthroplasty, run by Hasselt University at 2 sites in Belgium.
Trial summary
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hip Osteoarthritis, Total Hip Arthroplasty
- What is being tested?
- Total Hip Arthroplasty
- Type of treatment
- Surgery or procedure
- How many people
- 200 participants
- Where
- 2 sitesBelgium
- Study dates
- 4 May 2021to Feb 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Persons with hip osteoarthritis who will undergo THA
Who may be able to join
- Persons with a confirmed clinical or radiographic primary diagnosis of hip osteoarthritis who will undergo total hip arthroplasty (THA)
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Belgium2 sites, 2 recruiting
- Recruiting
Ziekenhuis Oost-Limburg
Genk, Limburg, 3600
Abner Sergooris, 003211299187, abner.sergooris@uhasselt.be
- Recruiting
Heuppraktijk
Herselt, Antwerpen, 2230
Abner Sergooris, 003211299187, abner.sergooris@uhasselt.be
About this study
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.
Read the detailed description
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.
- Conditions
- Hip Osteoarthritis, Total Hip Arthroplasty
- Being tested
- Total Hip Arthroplasty
- Keywords
- Hip Osteoarthritis, Total Hip Arthroplasty, Prognostic factors, Pain, Disability, Psychotraumatic events, Fear-Avoidance, Self-efficacy, Perceived Injustice, Quantitative Sensory Testing, Clinical phenotype, Psychopathology
- Medical subject headings
- Osteoarthritis, Hip, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Total Hip ArthroplastyProcedure or surgery
Direct Anterior Approach (DAA) Total Hip Arthroplasty (THA)
| Study group | Role | What they receive |
|---|---|---|
| Patients with hip osteoarthritis | Patients with hip osteoarthritis who will undergo total hip arthroplasty Receives: Procedure: Total Hip Arthroplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 12 months after THA
Secondary outcomes (42)
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'.
Measured: 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'.
Measured: 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'.
Measured: 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'.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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".
Measured: 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".
Measured: 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".
Measured: 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".
Measured: 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".
Measured: 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".
Measured: 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".
Measured: 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".
Measured: 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".
Measured: 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".
Measured: 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".
Measured: 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".
Measured: 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".
Measured: 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".
Measured: 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".
Measured: 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".
Measured: 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".
Measured: 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".
Measured: 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".
Measured: 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".
Measured: 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".
Measured: 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".
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 12 months after THA
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2022
- Study start4 May 2021
- Primary completionFeb 2024 (estimated)
- Study completionFeb 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Hip OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hasselt University
- Sponsor type
- University, hospital or other
- Collaborators
- Bijzonder onderzoeksfonds (BOF), Ziekenhuis Oost-Limburg
- Responsible party
- Principal investigator, Annick Timmermans, Hasselt University
- Investigators
- Annick Timmermans, Principal investigator, Hasselt UniversityKristoff Corten, Principal investigator, Ziekenhuis Oost-LimburgKatleen Bogaerts, Principal investigator, Hasselt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05265858
- Sponsor's protocol ID
- B3712021000002
- Other IDs
- CTU2020128
- Acronym
- HIPPROCLIPS
- Status last verified
- Feb 2022
- First submitted
- 9 Feb 2022
- Last updated
- 4 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sergooris A, Verbrugghe J, Bonnechere B, Matheve T, Corten K, Bogaerts K, Timmermans A. Inter-individual differences in early post-operative pain, cognitions, and emotions after total hip arthroplasty: A longitudinal cohort study. Clin Rehabil. 2025 Jun;39(6):784-795. doi: 10.1177/02692155251333537. Epub 2025 Apr 21.
PubMed 40255065Sergooris A, Verbrugghe J, Matheve T, Van Den Houte M, Bonnechere B, Corten K, Bogaerts K, Timmermans A. Clinical phenotypes and prognostic factors in persons with hip osteoarthritis undergoing total hip arthroplasty: protocol for a longitudinal prospective cohort study (HIPPROCLIPS). BMC Musculoskelet Disord. 2023 Mar 25;24(1):224. doi: 10.1186/s12891-023-06326-9.
PubMed 36964541
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Phenotypes in Persons With Hip Osteoarthritis and Prognostic Factors for Outcome After Total Hip Arthroplasty
- ClinicalTrials.gov ID
- NCT05265858
- Acronym / sponsor ID
- HIPPROCLIPS / B3712021000002
- Conditions
- Hip Osteoarthritis, Total Hip Arthroplasty
- Keywords
- Hip Osteoarthritis, Total Hip Arthroplasty, Prognostic factors, Pain, Disability, Psychotraumatic events, Fear-Avoidance, Self-efficacy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Hasselt UniversityUniversity, hospital or other
- Collaborators
- Bijzonder onderzoeksfonds (BOF), Ziekenhuis Oost-Limburg
- Study start
- 4 May 2021 (actual)
- Primary completion
- Feb 2024 (estimated)
- Study completion
- Feb 2024 (estimated)
- First posted
- 4 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with hip osteoarthritis | – | Procedure: Total Hip ArthroplastyPatients with hip osteoarthritis who will undergo total hip arthroplasty |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Persons with hip osteoarthritis who will undergo THA
Key inclusion criteria (1 listed)
- Persons with a confirmed clinical or radiographic primary diagnosis of hip osteoarthritis who will undergo total hip arthroplasty (THA)
Key exclusion criteria (8 listed)
- 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...)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Total Hip ArthroplastyDirect Anterior Approach (DAA) Total Hip Arthroplasty (THA) | Procedure or surgery | Patients with hip osteoarthritis |
Primary outcome
Hip disability and Osteoarthritis Outcome Score (HOOS)
Time frame: 1 week before THA
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.
Hip disability and Osteoarthritis Outcome Score (HOOS)
Time frame: 6 weeks after THA
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.
Hip disability and Osteoarthritis Outcome Score (HOOS)
Time frame: 3 months after THA
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.
Hip disability and Osteoarthritis Outcome Score (HOOS)
Time frame: 12 months after THA
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.
42 secondary outcomes
Patient Specific Functional Scale (PSFS)
Time frame: 1 week before THA
Patient Specific Functional Scale (PSFS)
Time frame: 6 weeks after THA
Patient Specific Functional Scale (PSFS)
Time frame: 3 months after THA
Patient Specific Functional Scale (PSFS)
Time frame: 12 months after THA
36-Item Short Form Health Survey (SF-36)
Time frame: 1 week before THA
36-Item Short Form Health Survey (SF-36)
Time frame: 6 weeks after THA
36-Item Short Form Health Survey (SF-36)
Time frame: 3 months after THA
36-Item Short Form Health Survey (SF-36)
Time frame: 12 months after THA
Global Perceived Effect (GPE)
Time frame: 1 day after THA
Global Perceived Effect (GPE)
Time frame: 3 days after THA
Global Perceived Effect (GPE)
Time frame: 5 days after THA
Global Perceived Effect (GPE)
Time frame: 7 days after THA
Global Perceived Effect (GPE)
Time frame: 6 weeks after THA
Global Perceived Effect (GPE)
Time frame: 3 months after THA
Global Perceived Effect (GPE)
Time frame: 12 months after THA
Numerical Rating Scale (NRS) of Patient Satisfaction
Time frame: 1 day after THA
Numerical Rating Scale (NRS) of Patient Satisfaction
Time frame: 3 days after THA
Numerical Rating Scale (NRS) of Patient Satisfaction
Time frame: 5 days after THA
Numerical Rating Scale (NRS) of Patient Satisfaction
Time frame: 7 days after THA
Numerical Rating Scale (NRS) of Patient Satisfaction
Time frame: 6 weeks after THA
Numerical Rating Scale (NRS) of Patient Satisfaction
Time frame: 3 months after THA
Numerical Rating Scale (NRS) of Patient Satisfaction
Time frame: 12 months after THA
Numerical Pain Rating Scale (NPRS)
Time frame: 1 week before THA
Numerical Pain Rating Scale (NPRS)
Time frame: 1 day after THA
Numerical Pain Rating Scale (NPRS)
Time frame: 3 days after THA
Numerical Pain Rating Scale (NPRS)
Time frame: 5 days after THA
Numerical Pain Rating Scale (NPRS)
Time frame: 7 days after THA
Numerical Pain Rating Scale (NPRS)
Time frame: 6 weeks after THA
Numerical Pain Rating Scale (NPRS)
Time frame: 3 months after THA
Numerical Pain Rating Scale (NPRS)
Time frame: 12 months after THA
30-second Chair Stand Test
Time frame: 1 week before THA
30-second Chair Stand Test
Time frame: 6 weeks after THA
30-second Chair Stand Test
Time frame: 3 months after THA
30-second Chair Stand Test
Time frame: 12 months after THA
11-step Stair Climb Test
Time frame: 1 week before THA
11-step Stair Climb Test
Time frame: 6 weeks after THA
11-step Stair Climb Test
Time frame: 3 months after THA
11-step Stair Climb Test
Time frame: 12 months after THA
40-meter (4x10-meter) Fast Paced Walk Test
Time frame: 1 week before THA
40-meter (4x10-meter) Fast Paced Walk Test
Time frame: 6 weeks after THA
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2022.
- Derived from this study: PubMed 40255065Sergooris A, Verbrugghe J, Bonnechere B, Matheve T, Corten K, Bogaerts K, Timmermans A. Inter-individual differences in early post-operative pain, cognitions, and emotions after total hip arthroplasty: A longitudinal cohort study. Clin Rehabil. 2025 Jun;39(6):784-795. doi: 10.1177/02692155251333537. Epub 2025 Apr 21.
- Derived from this study: PubMed 36964541Sergooris A, Verbrugghe J, Matheve T, Van Den Houte M, Bonnechere B, Corten K, Bogaerts K, Timmermans A. Clinical phenotypes and prognostic factors in persons with hip osteoarthritis undergoing total hip arthroplasty: protocol for a longitudinal prospective cohort study (HIPPROCLIPS). BMC Musculoskelet Disord. 2023 Mar 25;24(1):224. doi: 10.1186/s12891-023-06326-9.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Annick Timmermans principal investigator
Hasselt University
Kristoff Corten principal investigator
Ziekenhuis Oost-Limburg
Katleen Bogaerts principal investigator
Hasselt University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hip Osteoarthritis and Total Hip Arthroplasty, run by Hasselt University at 2 sites in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Abner Sergooris (003211299187, abner.sergooris@uhasselt.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hip disability and Osteoarthritis Outcome Score (HOOS) (time frame: 1 week before THA). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05265858, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2022.