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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Weight gainers | Weight gain 11-15 months after arthroplasty |
| |
| Weight losers | Weight loss11-15 months after arthroplasty |
| |
| Weight unchanged | Weight unchanged 11-15 months after arthroplasty |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Weight gain | Other | ≥5% weight gain |
| |
| Weight loss |
| 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 |
| 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 |
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Inclusion Criteria:
- Patients operated with primary hip or knee arthroplasty for osteoarthritis 11-15 months before survey distribution
Exclusion Criteria:
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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].
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Saber M. Saber, MD | Contact | 004521299265 | ssab0009@regionh.dk | |
| Jens Laigaard, MD | Contact | jens.holm.laigaard@regionh.dk |
| Name | Affiliation | Role |
|---|---|---|
| Søren Overgaard, MD,DMSc,Prof | Department of orthopedic surgery, Bispebjerg University Hospital, Denmark | Study Director |
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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 | Aug 29, 2023 | Aug 29, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| D015431 | Weight Loss |
| D015430 | Weight Gain |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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| Other |
≥5% weight loss after arthroplasty |
|
| Weight unchanged | Other | <5% weight change after arthroplasty |
|
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 |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D001836 | Body Weight Changes |
| D001835 | Body Weight |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |