Psychosocial Predictors of Poor Outcomes After a Knee Arthroplasty

NCT03378440 | Completed

• 1 other identifier: TKA-02
• Study Type: observational
• Target: 115
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteoarthritis, Knee

Outcome Measures

Primary Outcomes (2)

• Self-reported Pain

  Participants will be asked to rate their pain at resting, walking and flexing their knee on a horizontal 100-mm Visual Analogue Scale (VAS). The horizontal line anchors will be "no pain" and "worst imaginable pain". The VAS is a valid and reliable instrument compared with other pain rating scales, and has been well established in clinical practice and research for measuring pain levels in arthritis populations.

  Change from baseline to 1, 3 and 6 months after surgical intervention

• Disability / Limitations

  Western Ontario and McMaster University Osteoarthritis Index (WOMAC) (Spanish version) will be used to assess patient´s physical function. This questionnaire can be completed in less than 5 minutes. It's a widely used, reliable, valid and responsive measure of outcome in people with osteoarthritis of the hip or knee.

  Change from baseline to 1, 3 and 6 months after surgical intervention

Secondary Outcomes (8)

• Self-reported Quality of life

  1 week, 1 month, 3 months and 6 months after surgical intervention

• Kinesiophobia

  1 week, 1 month, 3 months and 6 months after surgical intervention

• Pain Attitudes

  1 week, 1 month, 3 months and 6 months after surgical intervention

• Depression and anxiety

  1 week, 1 month, 3 months and 6 months after surgical intervention

• Range of Motion

  1 week, 1 month, 3 months and 6 months after surgical intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Senior subjects with osteoarthritis scheduled for a total knee arthroplasty.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Barcelona: lead
• Hector Beltran-Alacreu, PhD: collaborator

Study Sites (1)

Iriteb S.L.

Badalona, Barcelona, 08912, Spain

Location

Related Publications (1)

• Terradas-Monllor M, Rierola-Fochs S, Merchan-Baeza JA, Pares-Martinez C, Font-Jutgla C, Hernandez-Hermoso JA, Ochandorena-Acha M. Comparison of pain, functional and psychological trajectories between total and unicompartmental knee arthroplasties: secondary analysis of a 6-month prospective observational study. Arch Orthop Trauma Surg. 2024 Dec 12;145(1):32. doi: 10.1007/s00402-024-05710-x.

  PMID: 39666075 DERIVED

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Francisco Maculé-Beneyto, PhD

  Hospital Clinic of Barcelona

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Marc Terradas-Monllor, PhD Student

Study Record Dates

• First Submitted: December 11, 2017
• First Posted: December 19, 2017
• Study Start: December 17, 2018
• Primary Completion: August 10, 2020
• Study Completion: September 8, 2020
• Last Updated: November 3, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)