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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06024161
• Other study ID #: p-2023-14578
• Status: Not yet recruiting
• Start date: November 1, 2023
• Est. completion date: November 30, 2024

Study information

• Verified date: August 2023
• Source: Bispebjerg Hospital
• Contact: Saber M. Saber, MD
• Phone: 004521299265
• Email: ssab0009[@]regionh.dk
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 6400
• Est. completion date: November 30, 2024
• Est. primary completion date: March 31, 2024
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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.

Related Conditions & MeSH terms

• Arthritis Knee
• Arthropathy of Hip
• Arthropathy of Knee
• Body Weight
• Body Weight Changes
• Chronic Pain
• Joint Diseases
• Obesity
• Pain, Postoperative
• Persistent Postsurgical Pain
• Weight Gain
• Weight Loss

Intervention

Other:
• Weight gain
=5% weight gain
• Weight loss
=5% weight loss after arthroplasty
• Weight unchanged
<5% weight change after arthroplasty

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bispebjerg Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Moderate/Severe Persistent Postoperative Pain	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)	11-15 months postsurgically
Secondary	Satisfaction	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)	11-15 months postsurgically
Secondary	Willingness to repeat the surgery	Answering "yes" in willlingness question The outcome will be presented as Odd Ratio (OR) with its' corresponding 95% Confidence Interval (CI)	11-15 months postsurgically
Secondary	Frequent pain	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)	11-15 months postsurgically
Secondary	Use of analgaesic	The outcome will be presented as Odd Ratio (OR) with its' corresponding 95% Confidence Interval (CI)	11-15 months postsurgically
Secondary	Interference with daily activities	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)	11-15 months postsurgically
Secondary	WOMAC pain score	mean (standard deviaiton [SD]). We will report the mean difference (MD) and the corresponding 95% CI	11-15 months postsurgically