Clinical trial NCT03378440: Psychosocial Predictors of Poor Outcomes After a Knee Arthroplasty
Official title: Psychosocial Predictors of Poor Outcomes After a Knee Arthroplasty: Prospective Observational Study.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Osteoarthritis, Knee
Lead sponsor: University of Barcelona
Sponsor class: OTHER
Collaborators: name: Hector Beltran-Alacreu, PhD
First posted: 2017-12-19
Enrollment: 115
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Senior subjects with osteoarthritis scheduled for a total knee arthroplasty.

Brief summary: The purpose of this study is to explore the association between the psychosocial variables: pain catastrophizing, fear of movement, coping skills, pain attitudes, anxiety and depression with postoperative outcomes (pain, health functioning, physical performance, and quality of life) after a knee arthroplasty (KA). The prevalence of KA has increased dramatically during the last two decades, its popularity can be attributed to its evident success regarding pain improvement, deformity correction and disability reduction in knee osteoarthritis subjects. However, only a third of the patients report no functional problems after surgery, the 20% of them are unsatisfied with its functional skills and around a 20% are experiencing pain, high disability degrees and a significant quality of life reduction. This results cannot be fully explained by mechanical processes, surgical procedures or surgery variations, but seems to be related to other psychological aspects. Chronic pain subjects often develop maladaptive thoughts and behaviours (i.e. pain catastrophism, kinesiophobia, activity avoidance) which contribute to make the subject suffer physically as well as emotionally, and affect on the intensity and persistency of pain.

This study is a single centre, prospective observational study of subjects undergoing primary KA. The study is designed and aimed to examine the relationship between postoperative psychosocial factors and the development of post-operative persistent pain and disability.


Eligibility criteria: Inclusion criteria:

1. To have sufficient Spanish or Catalan reading, writing and speaking skills to comprehend all explanations and to complete the assessment tools.
2. Be able to provide the informed consent.
3. Be scheduled to undergo in a total or unicompartimental knee arthroplasty.
4. Knee osteoarthritis diagnosis.
5. Patients 18 years old or more.

Exclusion criteria:

1. Patients scheduled to undergo in a total knee arthroplasty because of prostheses replacement, tumor, infection or fracture.
2. Patients scheduled to undergo in a bilateral total knee arthroplasty.
3. Patients that will need another total knee or hip replacement surgery in less than a year regarding the current intervention.
4. Patients with other pathologies with characteristic features of a central sensitization. (i.e. Fibromyalgia)
5. Co-existing other inflammatory or rheumatic conditions (i.e. rheumatoid arthritis, psoriatic arthritis, systemic lupus erythematosus or ankylosing spondylitis)
6. Co-existing other mental condition and/or major depression.

Primary outcomes:
measure: Self-reported Pain
timeFrame: Change from baseline to 1, 3 and 6 months after surgical intervention
measure: Disability / Limitations
timeFrame: Change from baseline to 1, 3 and 6 months after surgical intervention
Secondary outcomes:
measure: Self-reported Quality of life
timeFrame: 1 week, 1 month, 3 months and 6 months after surgical intervention
measure: Kinesiophobia
timeFrame: 1 week, 1 month, 3 months and 6 months after surgical intervention
measure: Pain Attitudes
timeFrame: 1 week, 1 month, 3 months and 6 months after surgical intervention
measure: Depression and anxiety
timeFrame: 1 week, 1 month, 3 months and 6 months after surgical intervention
measure: Range of Motion
timeFrame: 1 week, 1 month, 3 months and 6 months after surgical intervention
measure: Pain Catastrophism
timeFrame: 1 week, 1 month, 3 months and 6 months after surgical intervention
measure: Function
timeFrame: 1 week, 1 month, 3 months and 6 months after surgical intervention
measure: Walking Speed
timeFrame: 1 week, 1 month, 3 months and 6 months after surgical intervention
Other outcomes:
Locations:
city: Badalona
country: Spain
facility: Iriteb S.L.
state: Barcelona
Study officials:
affiliation: Hospital Clinic of Barcelona
name: Francisco Maculé-Beneyto, PhD
role: STUDY_DIRECTOR
References: