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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:
Participants will be asked to answer a 22-item questionnaire.
The study is registered at the Capitol region of Denmark's regional research listing (Pactius) with identifier P-2023-4, approved 4 January 2023. The resulting paper will be reported according to the CROSS checklist for standardised reporting of survey studies. Wherever needed, a trained linguist translated questions from English to Danish and vice versa. The Danish and an English version of the questionnaire will be available in the final publication.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Primary knee arthroplasty | Procedure | All patients surveyed have undergone primary knee arthroplasty approximately 1 year prior to survey distribution |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| How satisfied are you with the outcome of your knee replacement surgery? Very satisfied, Satisfied, Neither satisfied nor dissatisfied, Dissatisfied, Very dissatisfied | Reported as n (%) for each response option. The 1st question assesses overall satisfaction with surgery and have been translated directly from the questionnaire used by the Swedish Arthroplasty Register. | 11-15 months postsurgically |
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Inclusion Criteria:
- Patients operated with primary knee arthroplasty for osteoarthritis 12-15 months before survey distribution
Exclusion Criteria:
- Legally incompetent citizens, i.e., persons with a legal guardian, will not be asked to participate.
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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]).
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| Name | Affiliation | Role |
|---|---|---|
| Søren Overgaard, MD, PhD, Professor | Department of orthopedic surgery, Bispebjerg University Hospital, Denmark | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bispebjerg University Hospital | Copenhagen | 2200 | Denmark |
The full dataset will be stored at the Danish national archive (www.rigsarkivet.dk) if possible
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 2, 2023 | Jun 2, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| D009437 | Neuralgia |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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| 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 | Reported as n (%) for each response option. | 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 | Reported as n (%) for each response option. | 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'. | Reported as median (interquartile range [IQR]) and number of respondents | 11-15 months postsurgically |
| Pain domain of the likert-scale version 3.1 of the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC). | The five questions in the WOMAC pain domain can be scored 0-4, where 0 is 'none' and 4 is 'extreme'. This results in an overall score of 0-20, which will be reported as median (IQR). Moreover, each response option of the individual questions are reported as n (%). | 11-15 months postsurgically |
| Pain interference: In total, how much does the pain in the operated knee bother you in your everyday life? Not at all, A little, Some, Much, Very Much | Reported as n (%) for each response option | 11-15 months postsurgically |
| Douleur Neuropathique 4 questions (DN4) interview | Each of the seven questions in the DN4 interview can be scored 0/1 (no/yes), which results in an overall score of 0-7. A score ≥3 constitutes 'possible' neuropathic pain. Both the median (IQR) DN4 interview score and number of patients (% of all patients) with possible neuropathic pain will be reported. | 11-15 months postsurgically |
| Other pain: Do you have chronic pain, other than from your operated knee? Yes; No. [If yes] -> Please describe your pain condition | Pain conditions will be categorised independently by two authors and reported as n (%). | 11-15 months postsurgically |
| Analgesic use: Do you take analgesic medication(s) daily or almost daily? Yes; due to pain in the operated knee; Yes, due to other pain; No. [If yes] -> Which medication(s)?: | Reported as n (%). | 11-15 months postsurgically |
| Height (cm) | 11-15 months postsurgically |
| Weight (kg) | 11-15 months postsurgically |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |