Weight Change and the Risk of Chronic Pain Following Hip and Knee Arthroplasties

Not yet recruiting

• Conditions: Persistent Postsurgical Pain; Arthropathy of Knee; Arthropathy of Hip; Weight Loss; Weight Gain; Obesity; Arthritis Knee
• Interventions: Other: Weight unchanged; Other: Weight gain; Other: Weight loss

• Registration Number: NCT06024161
• Lead Sponsor: Bispebjerg Hospital

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-08
• Study First Submitted: 2023-08-29
• Study First Submitted QC: 2023-08-29
• Last Update Submitted: 2023-08-29
• Study First Posted: 2023-09-06
• Last Update Posted: 2023-09-06
• Study Start: 2023-11-01
• Primary Completion: 2024-03-31
• Study Completion: 2024-11-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 6400

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Weight unchanged	Weight unchanged	Weight unchanged 11-15 months after arthroplasty
Weight gainers	Weight gain	Weight gain 11-15 months after arthroplasty
Weight losers	Weight loss	Weight loss11-15 months after arthroplasty

Primary Outcome Measures

Name	Time	Method
Moderate/Severe Persistent Postoperative Pain	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 Outcome Measures

Name	Time	Method
Satisfaction	11-15 months postsurgically	Answering with "satisfied" or "very satisfied" in satisfaction question The outcome will be presented as Odd Ratio (OR) with its' corresponding 95% Confidence Interval (CI)
Interference with daily activities	11-15 months postsurgically	Answering "some", "much" and "very much" in the interference question The outcome will be presented as Odd Ratio (OR) with its' corresponding 95% Confidence Interval (CI)
Willingness to repeat the surgery	11-15 months postsurgically	Answering "yes" in willlingness question The outcome will be presented as Odd Ratio (OR) with its' corresponding 95% Confidence Interval (CI)
Frequent pain	11-15 months postsurgically	Experiencing pain constantly, daily or few times a week The outcome will be presented as Odd Ratio (OR) with its' corresponding 95% Confidence Interval (CI)
Use of analgaesic	11-15 months postsurgically	The outcome will be presented as Odd Ratio (OR) with its' corresponding 95% Confidence Interval (CI)
WOMAC pain score	11-15 months postsurgically	mean (standard deviaiton \[SD\]). We will report the mean difference (MD) and the corresponding 95% CI