Psychosocial Predictors of Poor Outcomes After a Knee Arthroplasty

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

115 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-12-17

Study Completion Date

2020-09-08

Brief Summary

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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.

Detailed Description

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Conditions

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Osteoarthritis, Knee

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Marc Terradas Monllor

Marc Terradas-Monllor, PhD Student

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Francisco Maculé-Beneyto, PhD

Role: STUDY_DIRECTOR

Hospital Clinic of Barcelona

Locations

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Iriteb S.L.

Badalona, Barcelona, Spain

Site Status

Countries

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Spain

References

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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.

Reference Type DERIVED

PMID: 39666075 (View on PubMed)

Other Identifiers

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TKA-02

Identifier Type: -

Identifier Source: org_study_id