ISRCTN96684272已完成未知
Osteoarthritis Preoperative Package for care of Orthotics, Rehabilitation, Topical and oral agent Usage and Nutrition to Improve ouTcomes at a Year (OPPORTUNITY)
HS Lothian0 个研究点目标入组 60 人开始时间: 2018年4月18日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 60
研究概览
简要总结
2020 Protocol article in https://www.ncbi.nlm.nih.gov/pubmed/32075663 protocol (added 24/02/2020) 2024 Results article in https://pubmed.ncbi.nlm.nih.gov/38423028/ (added 01/03/2024)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •For participants:
- •1. Undergoing total knee arthroplasty for OA
- •2. Participant meets at least 1 of the following threshold criteria:
- •2.1. BMI =30 kg/m2
- •2.2. Inability to perform straight leg raise (no extensor lag) or patient-reported ‘giving way’
- •2.3. Not taking appropriate analgesics unless analgesics are not tolerated/contra-indicated
- •2.4. Not using shock-absorbing footwear
- •3. Participants are able to consent and willing to comply with the study protocol
- •4. Sufficient time for the intervention to be delivered before planned date of surgery and for the follow up appointment to be conducted 3 months after planned date of surgery
- •Staff members to be interviewed should be members of the research team involved in delivering the intervention to participants or members of the clinical care team/associated personnel at the site where the intervention is being delivered.
- •The age range was omitted in V1 of the protocol but has been included in V2 (amendment currently being processed). The age range for the study is 18-85 years (inclusive).
排除标准
- •For participants:
- •1. Patients undergoing revision knee arthroplasty or fully constrained knee arthroplasty
- •2. Knee replacement for a diagnosis other than OA
- •3. Patients with a second contralateral procedure planned within the study timeframe
- •4. Procedures done purely for pain relief (such as for patients with no walking capacity)
- •5. Patients involved in another research study containing elements of behaviour change related to diet, physical activity and other study elements
- •6. Participants that cannot understand verbal explanations or written information given in English
- •7. Pregnant until >4 months postpartum; breastfeeding
- •Additional exclusion criteria applicable to participants eligible for weight loss aspect of the intervention:
- •1. Patients who have recently lost a significant amount of weight (>5kg in the preceding 3 months) or who are already on a specialised diet
- •2. Patients with:
- •2.1. Insulin dependent diabetes
- •2.2. Brittle type 2 diabetes which is managed in secondary care (confirmed by recent HbA1c measurement if available)
- •2.3. Patients with moderate or severe retinopathy
- •3. Patients taking 4 or more antihypertensive agents
- •4. Patients with active mental illness: severe depression, bipolar disorders, schizophrenia or other psychotic disorders
- •5. Myocardial infarctions or stroke within the previous 3 months
- •6. Heart failure of grade III New York Heart Association or more severe
- •7. Porphyria
- •8. Substance abuse e.g., drugs, alcohol
- •9. Eating disorder accompanied by purging (through laxative abuse or induced vomiting)
- •10. Previous bariatric surgery or scheduled bariatric surgery
- •11. Angina, arrhythmia, including atrial fibrillation or prolonged QT syndrome
- •12. Taking monoamine- oxidase inhibitor (MAOI) medication
- •13. Taking anticoagulant medication (e.g., warfarin)
- •14. Taking varenicline (smoking cessation medication)
- •15. Chronic renal failure of stage 4 or 5 (as indicated by a recent eGFR reading of <30mls/min/1.73)
- •16. Patients:
- •16.1. With active liver disease (except non-alcoholic fatty liver disease (NAFLD)
- •16.2. With a history of hepatoma
- •16.3. Within 6 months of onset of acute hepatitis
- •17. People having active treatment for cancer other than skin cancer treated with curative intent by local treatment only, or people taking hormonal or other long-term secondary prevention treatment after initial cancer treatment
- •18. Active treatment or investigation for possible or confirmed gastric or duodenal ulcer; maintenance treatment with acid suppression is not a contraindication
- •19. Displaying symptoms associated with gallstones in the last 3 months
- •20. Not taking a proton-pump inhibitor if taking oral ibuprofen
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