Clinical trial NCT05265858: Clinical Phenotypes in Persons With Hip Osteoarthritis and Prognostic Factors for Outcome After Total Hip Arthroplasty
Official title: Clinical Phenotypes in Persons With Hip Osteoarthritis and Prognostic Factors for Outcome After Total Hip Arthroplasty
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hip Osteoarthritis
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
Lead sponsor: Hasselt University
Sponsor class: OTHER
Collaborators: name: Bijzonder onderzoeksfonds (BOF)
name: Ziekenhuis Oost-Limburg
First posted: 2022-03-04
Enrollment: 200
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Persons with hip osteoarthritis who will undergo THA

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Hip disability and Osteoarthritis Outcome Score (HOOS)
timeFrame: 1 week before THA
measure: Hip disability and Osteoarthritis Outcome Score (HOOS)
timeFrame: 6 weeks after THA
measure: Hip disability and Osteoarthritis Outcome Score (HOOS)
timeFrame: 3 months after THA
measure: Hip disability and Osteoarthritis Outcome Score (HOOS)
timeFrame: 12 months after THA
Secondary outcomes:
measure: Patient Specific Functional Scale (PSFS)
timeFrame: 1 week before THA
measure: Patient Specific Functional Scale (PSFS)
timeFrame: 6 weeks after THA
measure: Patient Specific Functional Scale (PSFS)
timeFrame: 3 months after THA
measure: Patient Specific Functional Scale (PSFS)
timeFrame: 12 months after THA
measure: 36-Item Short Form Health Survey (SF-36)
timeFrame: 1 week before THA
measure: 36-Item Short Form Health Survey (SF-36)
timeFrame: 6 weeks after THA
measure: 36-Item Short Form Health Survey (SF-36)
timeFrame: 3 months after THA
measure: 36-Item Short Form Health Survey (SF-36)
timeFrame: 12 months after THA
measure: Global Perceived Effect (GPE)
timeFrame: 1 day after THA
measure: Global Perceived Effect (GPE)
timeFrame: 3 days after THA
measure: Global Perceived Effect (GPE)
timeFrame: 5 days after THA
measure: Global Perceived Effect (GPE)
timeFrame: 7 days after THA
measure: Global Perceived Effect (GPE)
timeFrame: 6 weeks after THA
measure: Global Perceived Effect (GPE)
timeFrame: 3 months after THA
measure: Global Perceived Effect (GPE)
timeFrame: 12 months after THA
measure: Numerical Rating Scale (NRS) of Patient Satisfaction
timeFrame: 1 day after THA
measure: Numerical Rating Scale (NRS) of Patient Satisfaction
timeFrame: 3 days after THA
measure: Numerical Rating Scale (NRS) of Patient Satisfaction
timeFrame: 5 days after THA
measure: Numerical Rating Scale (NRS) of Patient Satisfaction
timeFrame: 7 days after THA
measure: Numerical Rating Scale (NRS) of Patient Satisfaction
timeFrame: 6 weeks after THA
measure: Numerical Rating Scale (NRS) of Patient Satisfaction
timeFrame: 3 months after THA
measure: Numerical Rating Scale (NRS) of Patient Satisfaction
timeFrame: 12 months after THA
measure: Numerical Pain Rating Scale (NPRS)
timeFrame: 1 week before THA
measure: Numerical Pain Rating Scale (NPRS)
timeFrame: 1 day after THA
measure: Numerical Pain Rating Scale (NPRS)
timeFrame: 3 days after THA
measure: Numerical Pain Rating Scale (NPRS)
timeFrame: 5 days after THA
measure: Numerical Pain Rating Scale (NPRS)
timeFrame: 7 days after THA
measure: Numerical Pain Rating Scale (NPRS)
timeFrame: 6 weeks after THA
measure: Numerical Pain Rating Scale (NPRS)
timeFrame: 3 months after THA
measure: Numerical Pain Rating Scale (NPRS)
timeFrame: 12 months after THA
measure: 30-second Chair Stand Test
timeFrame: 1 week before THA
measure: 30-second Chair Stand Test
timeFrame: 6 weeks after THA
measure: 30-second Chair Stand Test
timeFrame: 3 months after THA
measure: 30-second Chair Stand Test
timeFrame: 12 months after THA
measure: 11-step Stair Climb Test
timeFrame: 1 week before THA
measure: 11-step Stair Climb Test
timeFrame: 6 weeks after THA
measure: 11-step Stair Climb Test
timeFrame: 3 months after THA
measure: 11-step Stair Climb Test
timeFrame: 12 months after THA
measure: 40-meter (4x10-meter) Fast Paced Walk Test
timeFrame: 1 week before THA
measure: 40-meter (4x10-meter) Fast Paced Walk Test
timeFrame: 6 weeks after THA
measure: 40-meter (4x10-meter) Fast Paced Walk Test
timeFrame: 3 months after THA
measure: 40-meter (4x10-meter) Fast Paced Walk Test
timeFrame: 12 months after THA
Other outcomes:
measure: Thermal Detection and Pain Threshold Temperatures
timeFrame: 1 week before THA
measure: Thermal Detection and Pain Threshold Temperatures
timeFrame: 6 weeks after THA
measure: Thermal Detection and Pain Threshold Temperatures
timeFrame: 3 months after THA
measure: Thermal Detection and Pain Threshold Temperatures
timeFrame: 12 months after THA
measure: Temporal Summation of Pain (TSP)
timeFrame: 1 week before THA
measure: Temporal Summation of Pain (TSP)
timeFrame: 6 weeks after THA
measure: Temporal Summation of Pain (TSP)
timeFrame: 3 months after THA
measure: Temporal Summation of Pain (TSP)
timeFrame: 12 months after THA
measure: Conditioned Pain Modulation (CPM)
timeFrame: 1 week before THA
measure: Conditioned Pain Modulation (CPM)
timeFrame: 6 weeks after THA
measure: Conditioned Pain Modulation (CPM)
timeFrame: 3 months after THA
measure: Conditioned Pain Modulation (CPM)
timeFrame: 12 months after THA
measure: Mini International Neuropsychiatric Interview - Simplified (M.I.N.I.-S for DSM-V)
timeFrame: 1 week before THA
measure: Mini International Neuropsychiatric Interview - Simplified (M.I.N.I.-S for DSM-V)
timeFrame: 12 months after THA
measure: Traumatic Experiences Checklist (TEC)
timeFrame: 1 week before THA
measure: Traumatic Experiences Checklist (TEC)
timeFrame: 12 months after THA
measure: Childhood Trauma Questionnaire (CTQ)
timeFrame: 1 week before THA
measure: Childhood Trauma Questionnaire (CTQ)
timeFrame: 12 months after THA
measure: Hospital Anxiety and Depression Scale (HADS)
timeFrame: 1 week before THA
measure: Hospital Anxiety and Depression Scale (HADS)
timeFrame: 1 week after THA
measure: Hospital Anxiety and Depression Scale (HADS)
timeFrame: 6 weeks after THA
measure: Hospital Anxiety and Depression Scale (HADS)
timeFrame: 3 months after THA
measure: Hospital Anxiety and Depression Scale (HADS)
timeFrame: 12 months after THA
measure: Fear-Avoidance Component Scale (FACS)
timeFrame: 1 week before THA
measure: Fear-Avoidance Component Scale (FACS)
timeFrame: 1 week after THA
measure: Fear-Avoidance Component Scale (FACS)
timeFrame: 6 weeks after THA
measure: Fear-Avoidance Component Scale (FACS)
timeFrame: 3 months after THA
measure: Fear-Avoidance Component Scale (FACS)
timeFrame: 12 months after THA
measure: Tampa Scale for Kinesiophobia (TSK-17)
timeFrame: 1 week before THA
measure: Tampa Scale for Kinesiophobia (TSK-17)
timeFrame: 1 week after THA
measure: Tampa Scale for Kinesiophobia (TSK-17)
timeFrame: 6 weeks after THA
measure: Tampa Scale for Kinesiophobia (TSK-17)
timeFrame: 3 months after THA
measure: Tampa Scale for Kinesiophobia (TSK-17)
timeFrame: 12 months after THA
measure: Injustice Experience Questionnaire (IEQ)
timeFrame: 1 week before THA
measure: Injustice Experience Questionnaire (IEQ)
timeFrame: 1 week after THA
measure: Injustice Experience Questionnaire (IEQ)
timeFrame: 6 weeks after THA
measure: Injustice Experience Questionnaire (IEQ)
timeFrame: 3 months after THA
measure: Injustice Experience Questionnaire (IEQ)
timeFrame: 12 months after THA
measure: General Self-Efficacy Scale (GSES)
timeFrame: 1 week before THA
measure: General Self-Efficacy Scale (GSES)
timeFrame: 6 weeks after THA
measure: General Self-Efficacy Scale (GSES)
timeFrame: 3 months after THA
measure: General Self-Efficacy Scale (GSES)
timeFrame: 12 months after THA
measure: Groningen Orthopaedic Social Support Scale (GO-SSS)
timeFrame: 1 week before THA
measure: Groningen Orthopaedic Social Support Scale (GO-SSS)
timeFrame: 6 weeks after THA
measure: Groningen Orthopaedic Social Support Scale (GO-SSS)
timeFrame: 3 months after THA
measure: Groningen Orthopaedic Social Support Scale (GO-SSS)
timeFrame: 12 months after THA
measure: Muscle strength
timeFrame: 1 week before THA
measure: Muscle strength
timeFrame: 6 weeks after THA
measure: Muscle strength
timeFrame: 3 months after THA
measure: Muscle strength
timeFrame: 12 months after THA
measure: Perceived stress
timeFrame: 1 week before THA
measure: Perceived stress
timeFrame: 1 day after THA
measure: Perceived stress
timeFrame: 3 days after THA
measure: Perceived stress
timeFrame: 5 days after THA
measure: Perceived stress
timeFrame: 7 days after THA
measure: Perceived stress
timeFrame: 6 weeks after THA
measure: Perceived stress
timeFrame: 3 months after THA
measure: Perceived stress
timeFrame: 12 months after THA
Locations:
city: Herselt
country: Belgium
facility: Heuppraktijk
state: Antwerpen
city: Genk
country: Belgium
facility: Ziekenhuis Oost-Limburg
state: Limburg
Study officials:
affiliation: Hasselt University
name: Annick Timmermans
role: PRINCIPAL_INVESTIGATOR
affiliation: Ziekenhuis Oost-Limburg
name: Kristoff Corten
role: PRINCIPAL_INVESTIGATOR
affiliation: Hasselt University
name: Katleen Bogaerts
role: PRINCIPAL_INVESTIGATOR
References: