Persistent Pain After Knee Replacement

NCT05900791 | Completed

• 1 other identifier: P-2023-4
• Study Type: observational
• Target: 3,710
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a nationwide cross-sectional survey on pain and satisfaction after knee arthroplasty (KA). Please find the full protocol uploaded at ClinicalTrials.gov The goal of this observational study is to study pain and satisfaction in patients operated with knee arthroplasty. The main question it aims to answer are:

• What is the incidence of persistent postsurgical pain in unselected knee arthroplasty patients
• What is the level of satisfaction in unselected knee arthroplasty patients? Participants will be asked to answer a 22-item questionnaire.

Conditions

Persistent Postsurgical Pain; Arthritis Knee; Neuropathic Pain; Opioid Use

Outcome Measures

Primary Outcomes (1)

• Moderate/Severe persistent postsurgical pain

  The main outcome is the number of patients with moderate or severe persistent postsurgical pain in the operated knee, defined as patients with a numerical rating scale (NRS) score higher than 3. The NRS score was dichotomised for the primary outcome because this is more intuitively understood by patients and clinicians. This outcome will be reported as percentage of all patients with 95% confidence interval, which is calculated with assumed binomial distribution as p ± 1.96 √( (p (1 - p) ) / n)

  11-15 months postsurgically

Secondary Outcomes (11)

• How satisfied are you with the outcome of your knee replacement surgery? Very satisfied, Satisfied, Neither satisfied nor dissatisfied, Dissatisfied, Very dissatisfied

  11-15 months postsurgically

• Knowing what your knee replacement surgery did for you, if you could go back in time, would you still have undergone this surgery? Yes, No, Uncertain

  11-15 months postsurgically

• Pain frequency: Do you still have pain in the operated knee? Yes, constantly; Yes, daily; Yes, a few times a week; Yes, more rarely; No

  11-15 months postsurgically

• Numerical Rating Scale (NRS) pain: Please rate your pain in the operated knee by indicating the number that best describes your pain on average during the last week. 0 means 'No pain' and '10' means 'Pain as bad as you can imagine'.

  11-15 months postsurgically

• Pain domain of the likert-scale version 3.1 of the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC).

  11-15 months postsurgically

Interventions

Primary knee arthroplasty PROCEDURE

All patients surveyed have undergone primary knee arthroplasty approximately 1 year prior to survey distribution

Also known as: Primary knee replacement

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

For total KA, patients are identified from the Danish National Patient Register through the Danish Health Data Authority (SKS-code DM17 \[knee osteoarthritis\] + KNGB20, KNGB30 or KNGB40 \[primary total knee arthroplasty\]). For medial unicompartmental KA, patients are identified from the Danish National Patient Register through the Danish Health Data Authority (SKS-code DM17 \[knee osteoarthritis\] + KNGB01 or KNGB11 \[primary medial unicompartmental knee arthroplasty\]).

You may qualify if:

• \- Patients operated with primary knee arthroplasty for osteoarthritis 12-15 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

• University Hospital Bispebjerg and Frederiksberg: lead

Study Sites (1)

Bispebjerg University Hospital

Copenhagen, 2200, Denmark

Location

MeSH Terms

Conditions

Pain, Postoperative; Neuralgia

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases

Study Officials

• Søren Overgaard, MD, PhD, Professor

  Department of orthopedic surgery, Bispebjerg University Hospital, Denmark

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: June 2, 2023
• First Posted: June 13, 2023
• Study Start: November 1, 2023
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: May 15, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)