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

NCT06024161 | Unknown

• 1 other identifier: p-2023-14578
• Study Type: observational
• Target: 6,400
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Persistent Postsurgical Pain; Arthritis Knee; Arthropathy of Knee; Arthropathy of Hip; Weight Loss; Weight Gain; Obesity

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Satisfaction

  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

• Interference with daily activities

  11-15 months postsurgically

Study Arms (3)

Weight gainers

Weight gain 11-15 months after arthroplasty

Other: Weight gain

Weight losers

Weight loss11-15 months after arthroplasty

Other: Weight loss

Weight unchanged

Weight unchanged 11-15 months after arthroplasty

Other: Weight unchanged

Interventions

Weight gain OTHER

≥5% weight gain

Weight gainers

Weight loss OTHER

≥5% weight loss after arthroplasty

Weight losers

Weight unchanged OTHER

\<5% weight change after arthroplasty

Weight unchanged

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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 \[primary medial unicompartmental knee arthroplasty\].

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Bispebjerg Hospital: lead

MeSH Terms

Conditions

Pain, Postoperative; Weight Loss; Weight Gain; Obesity

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Body Weight Changes; Body Weight; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Study Officials

• Søren Overgaard, MD,DMSc,Prof

  Department of orthopedic surgery, Bispebjerg University Hospital, Denmark

  STUDY DIRECTOR

Central Study Contacts

Saber M. Saber, MD

CONTACT

004521299265; ssab0009@regionh.dk

Jens Laigaard, MD

CONTACT

jens.holm.laigaard@regionh.dk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 15 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD fellow

Study Record Dates

• First Submitted: August 29, 2023
• First Posted: September 6, 2023
• Study Start: November 1, 2023
• Primary Completion: March 31, 2024
• Study Completion: November 30, 2024
• Last Updated: September 6, 2023

Record last verified: 2023-08