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

Sponsor

Bispebjerg Hospital (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06024161

Collaborator

(none)

6,400

Enrollment

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Persistent Postsurgical Pain Arthritis Knee Arthropathy of Knee Arthropathy of Hip Weight Loss Weight Gain Obesity	Other: Weight gain Other: Weight loss Other: Weight unchanged

Study Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

6400 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Anticipated Study Start Date :

Nov 1, 2023

Anticipated Primary Completion Date :

Mar 31, 2024

Anticipated Study Completion Date :

Nov 30, 2024

Arms and Interventions

Arm	Intervention/Treatment
Weight gainers Weight gain 11-15 months after arthroplasty	Other: Weight gain ≥5% weight gain
Weight losers Weight loss11-15 months after arthroplasty	Other: Weight loss ≥5% weight loss after arthroplasty
Weight unchanged Weight unchanged 11-15 months after arthroplasty	Other: Weight unchanged <5% weight change after arthroplasty

Arm

Intervention/Treatment

Weight gainers

Weight gain 11-15 months after arthroplasty

Other: Weight gain

≥5% weight gain

Weight losers

Weight loss11-15 months after arthroplasty

Other: Weight loss

≥5% weight loss after arthroplasty

Weight unchanged

Weight unchanged 11-15 months after arthroplasty

Other: Weight unchanged

<5% weight change after arthroplasty

Outcome Measures

Primary Outcome Measures

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

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)
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)
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)
WOMAC pain score [11-15 months postsurgically]
mean (standard deviaiton [SD]). We will report the mean difference (MD) and the corresponding 95% CI