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Clinical Trials/NCT06024161
NCT06024161Not yet recruitingNot Applicable

Weight Change and the Risk of Chronic Pain Following Hip and Knee Arthroplasties: A Nationwide Registry-based Cohort Survey Study.

Bispebjerg Hospital0 sites6,400 target enrollmentStarted: November 1, 2023Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Enrollment
6,400
Primary Endpoint
Moderate/Severe Persistent Postoperative Pain
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

The study is a nationwide, register-based cohort survey study. The objective of this study is to investigate whether weight change is associated with the incidence of persistent postoperative pain following total hip arthroplasty and knee arthroplasty across non-obese and obese and patients.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to 99 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Patients operated with primary hip or knee arthroplasty for osteoarthritis 11-15 months before survey distribution

Exclusion Criteria

  • •Legally incompetent citizens, i.e., persons with a legal guardian, will not be asked to participate.

Outcomes

Primary Outcomes

Moderate/Severe Persistent Postoperative Pain

Time Frame: 11-15 months postsurgically

The primary outcome is the number of patients with moderate or severe persistent postsurgical pain in the operated hip or knee, defined as patients with a numerical rating scale (NRS) score higher than 3. The outcome will be presented as Odd Ratio (OR) with its' corresponding 95% Confidence Interval (CI)

Secondary Outcomes

  • Satisfaction(11-15 months postsurgically)
  • Interference with daily activities(11-15 months postsurgically)
  • Willingness to repeat the surgery(11-15 months postsurgically)
  • Frequent pain(11-15 months postsurgically)
  • Use of analgaesic(11-15 months postsurgically)
  • WOMAC pain score(11-15 months postsurgically)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Saber Muthanna Saber

MD, PhD fellow

Bispebjerg Hospital

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