Osteoarthritis preoperative package for care of orthotics, rehabilitation, topical and oral agent usage and nutrition to improve outcomes at a year

Not Applicable

Completed

• Conditions: Osteoarthritis; Musculoskeletal Diseases

• Registration Number: ISRCTN96684272
• Lead Sponsor: HS Lothian

Brief Summary

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)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-04-18
• Study Completion: 2020-03-20
• Last Update Posted: 11 March 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

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

For staff:
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).

Exclusion Criteria

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified