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

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

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 Overview

• Status: Not yet recruiting
• Conditions: Obesity; Weight Loss; Weight Gain; Arthropathy of Knee; Arthropathy of Hip; Arthritis Knee; Persistent Postsurgical Pain
• Intervention / Treatment: Other: Weight gain; Other: Weight loss; Other: Weight unchanged

• Study Type: Observational
• Enrollment (Estimated): 6400

Contacts and Locations

• Study Contact: Name: Saber M. Saber, MD; Phone Number: 004521299265; Email: ssab0009@regionh.dk
• Study Contact Backup: Name: Jens Laigaard, MD; Email: jens.holm.laigaard@regionh.dk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

Patients will be identified based on the NOMESCO (Nordic Medico-Statistical Committee) Classification of Surgical Procedures from the the Danish National Patient Register by using SKS-code the codes for THA patients will be SKS-code DM16 [hip osteoarthritis] + KNFB20 or KNFB30 or KNFB40[Primary Total Hip Arthroplasty]. For total knee arthroplasty (TKA), SKS-code DM17 [knee osteoarthritis] + KNGB20, KNGB30 or KNGB40 [primary total knee arthroplasty]. For medial unicompartmental knee arthroplasty (UKA), SKS-code DM17 [knee osteoarthritis] + KNGB01 or KNGB11 [primary medial unicompartmental knee arthroplasty].

Description

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 Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
Use of analgaesic	The outcome will be presented as Odd Ratio (OR) with its' corresponding 95% Confidence Interval (CI)	11-15 months postsurgically
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
WOMAC pain score	mean (standard deviaiton [SD]). We will report the mean difference (MD) and the corresponding 95% CI	11-15 months postsurgically

Collaborators and Investigators

• Sponsor: Bispebjerg Hospital
• Investigators: Study Director: Søren Overgaard, MD,DMSc,Prof, Department of orthopedic surgery, Bispebjerg University Hospital, Denmark

Study record dates

Study Major Dates

• Study Start (Estimated): November 1, 2023
• Primary Completion (Estimated): March 31, 2024
• Study Completion (Estimated): November 30, 2024

Study Registration Dates

• First Submitted: August 29, 2023
• First Submitted That Met QC Criteria: August 29, 2023
• First Posted (Actual): September 6, 2023

Study Record Updates

• Last Update Posted (Actual): September 6, 2023
• Last Update Submitted That Met QC Criteria: August 29, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Musculoskeletal Diseases; Pain, Postoperative; Chronic Pain; Weight Loss; Joint Diseases; Body Weight; Body Weight Changes; Weight Gain
• Other Study ID Numbers: p-2023-14578

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No