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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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13 June 2016 |
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Main ID: |
NCT02253966 |
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Date of registration:
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29/09/2014 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Preoperative Intraarticular Injection of Methylprednisolone in Patients Scheduled for Total Knee-arthroplasty
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Scientific title:
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Date of first enrolment:
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October 2014 |
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Target sample size:
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48 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02253966 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
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Phase:
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Phase 2
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Countries of recruitment
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Denmark
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Age 50 -80
- Osteoarthrosis
- Scheduled for primary unilateral TKA
- Preoperative pain report with NRS > 5 upon walking
- Signs of sensitisation in knee
Exclusion Criteria:
- Allergies to methylprednisoloneacetate, lidocaine or standard analgesic treatment
- Deficient written or spoken danish
- Impairment from psychological or neurological disease
- Local og systemic infection
- Immunodeficiency
- Treatment with corticosteroid within 30 days of inclusion
- Insulin treated diabetes mellitus
- Anticoagulant therapy
- ASA (American Society of Anaesthesia) class > 3
- General anaesthesia
- Alchohol use > 21 units / week
- Pregnancy
Age minimum:
50 Years
Age maximum:
80 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Hyperalgesia
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Knee Joint Osteoarthrosis
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Severe Movement Related Pain
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Intervention(s)
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Drug: Methylprednisoloneacetate
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Drug: Lidocaine
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Other: sodium chloride
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Primary Outcome(s)
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Pain
[Time Frame: 24 hours postoperatively]
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Secondary Outcome(s)
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Inflammation
[Time Frame: On day 0 and day 2]
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Pain
[Time Frame: From day 1 to day 14]
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Inflammation
[Time Frame: On day 0]
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Sensitisation
[Time Frame: On day 0 and day 2]
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Pain
[Time Frame: 48 hours postoperatively]
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Secondary ID(s)
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H-3-2014-089
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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