Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 5:06 AM
Ignite Modification Date:
2025-12-25 @ 5:06 AM
NCT ID:
NCT05601427
Eligibility Criteria:
Inclusion Criteria:
1. Male and female patients aged 18 years or older
2. Primary TKA booked as SDD
3. Diagnosis of osteoarthritis
Exclusion Criteria:
1. Inability or refusal to sign informed consent form
2. Non-English or French speaking, and no licensed translator, family member or substitute decision maker available.
3. Non-osteoarthritis primary diagnosis
4. Allergy to analgesic medications
5. Contraindication to spinal and/or regional anaesthesia
6. Any use of opioid pain medication within four weeks of the index procedure(13)
7. Pain catastrophizing scale score ≥16 (8, 9, 14)
8. History of cirrhosis
9. History renal insufficiency
10. History or sensory and/or motor neuropathy to the ipsilateral limb
11. Simultaneous, bilateral TKA
12. Non-TKA prosthesis
13. Scheduled for non-SDD TKA.
14. Preoperative varus/valgus of \>10 degrees.
15. Planned General Anaesthetic
16. Use of Intrathecal Morphine
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05601427
Study Brief:
Protocol Section:
NCT05601427