Preoperative Intraarticular Injection of Methylprednisolone in Patients Scheduled for Total Knee-arthroplasty
1 other identifier
interventional
48
1 country
1
Brief Summary
Despite improvements in analgesic treatment following total knee arthroplasty (TKA) for osteoarthrosis, a substantial part of patients still have severe acute pain after surgery. It has been suggested that preoperative degree of intraarticular inflammation is associated to postoperative degree of pain and level of function. Furthermore it is known, that patients with preoperative inflammation have hyperalgesia and severe movement related pain. The aim of this study is to investigate the effect of a preoperative intraarticular injection of Methylprednisoloneacetate in reducing acute postoperative pain after total knee arthroplasty in patients with signs of severe pre-operative inflammation and pain.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Oct 2014
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 29, 2014
CompletedFirst Posted
Study publicly available on registry
October 1, 2014
CompletedStudy Start
First participant enrolled
October 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2016
CompletedJune 6, 2016
June 1, 2016
1.4 years
September 29, 2014
June 3, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Pain
Pain intensity on a numeric rang scale (NRS) from 0 to 10 upon ambulation 24 hours following surgery
24 hours postoperatively
Secondary Outcomes (6)
Pain
48 hours postoperatively
Pain
From day 1 to day 14
Pain
From day 1 to day 14
Sensitisation
On day 0 and day 2
Inflammation
On day 0 and day 2
- +1 more secondary outcomes
Study Arms (2)
Methylprednisoloneacetate
ACTIVE COMPARATORAdministration of: 1 ml methylprednisoloneacetate 40 mg/ml 5 ml lidocaine 20 mg/ml 4 ml sodium chloride 9 mg/ml as a single intraarticular injection 7 days prior to surgery.
Sodium chloride
PLACEBO COMPARATORAdministration of: 5 ml lidocaine 20 mg/ml 5 ml sodium chloride 9 mg/ml as a singe intraarticular injection 7 days prior to surgery.
Interventions
Eligibility Criteria
You may qualify if:
- Age 50 -80
- Osteoarthrosis
- Scheduled for primary unilateral TKA
- Preoperative pain report with NRS \> 5 upon walking
- Signs of sensitisation in knee
You may not qualify if:
- Allergies to methylprednisoloneacetate, lidocaine or standard analgesic treatment
- Deficient written or spoken danish
- Impairment from psychological or neurological disease
- Local og systemic infection
- Immunodeficiency
- Insulin treated diabetes mellitus
- Anticoagulant therapy
- ASA (American Society of Anaesthesia) class \> 3
- General anaesthesia
- Alchohol use \> 21 units / week
- Pregnancy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Rigshospitalet, Denmarklead
- Lundbeck Foundationcollaborator
Study Sites (1)
Gentofte Hospital
Hellerup, 2900, Denmark
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD, Research Fellow
Study Record Dates
First Submitted
September 29, 2014
First Posted
October 1, 2014
Study Start
October 1, 2014
Primary Completion
March 1, 2016
Study Completion
March 1, 2016
Last Updated
June 6, 2016
Record last verified: 2016-06