An observational study in Persistent Postsurgical Pain, Arthritis Knee and Arthropathy of Knee, sponsored by Bispebjerg Hospital. Not yet recruiting. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2023-09-06.
Sponsored by Bispebjerg Hospital · Observational
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.
5,640 studies on the registry are indexed under Pain, Postoperative; 1,230 are open to participants now.
This study's planned enrollment of 6,400 is above the median of 102 across 683 observational studies indexed under Pain, Postoperative.
Browse Pain, Postoperative studies →Bispebjerg Hospital is the lead sponsor of 289 studies on the registry; 29 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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].
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Weight gain 11-15 months after arthroplasty
Other: Weight gain
Weight loss11-15 months after arthroplasty
Other: Weight loss
Weight unchanged 11-15 months after arthroplasty
Other: Weight unchanged
≥5% weight gain
≥5% weight loss after arthroplasty
\<5% weight change after arthroplasty
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)
Time frame: 11-15 months postsurgically
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)
Time frame: 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)
Time frame: 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)
Time frame: 11-15 months postsurgically
Use of analgaesic
The outcome will be presented as Odd Ratio (OR) with its' corresponding 95% Confidence Interval (CI)
Time frame: 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)
Time frame: 11-15 months postsurgically
WOMAC pain score
mean (standard deviaiton \[SD\]). We will report the mean difference (MD) and the corresponding 95% CI
Time frame: 11-15 months postsurgically
No study locations are listed for this record.
PDFs hosted by the registry, ClinicalTrials.gov.
Start is estimated for Nov 2023; primary completion for Mar 2024, 4 months later.
Of 391 non-industry observational studies under Pain, Postoperative, half reached primary completion within 13 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 32. This study's planned 4 months is below that.
Counting every sponsor, half of 395 studies reached it within 13 months; a quarter within 5 and three quarters within 33.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Aug 2023. You cannot join it, but the record below documents what was studied.
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