Preoperative Intraarticular Injection of Methylprednisolone in Patients Scheduled for Total Knee-arthroplasty

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-10-31

Study Completion Date

2016-03-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Knee Joint Osteoarthrosis Hyperalgesia Severe Movement Related Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Methylprednisoloneacetate

Administration 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.

Group Type ACTIVE_COMPARATOR

Methylprednisoloneacetate

Intervention Type DRUG

Lidocaine

Intervention Type DRUG

sodium chloride

Intervention Type OTHER

Sodium chloride

Administration of:

5 ml lidocaine 20 mg/ml 5 ml sodium chloride 9 mg/ml as a singe intraarticular injection 7 days prior to surgery.

Group Type PLACEBO_COMPARATOR

Lidocaine

Intervention Type DRUG

sodium chloride

Intervention Type OTHER

Interventions

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Methylprednisoloneacetate

Intervention Type DRUG

Lidocaine

Intervention Type DRUG

sodium chloride

Intervention Type OTHER

Other Intervention Names

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Depo-Medrol saline

Eligibility 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

Minimum Eligible Age

50 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No