Effect of Methylprednisolone on Quadriceps Muscle Function in Patients Undergoing Total Knee-arthroplasty

April 7, 2016 updated by: Viktoria Oline Lindberg-Larsen, Rigshospitalet, Denmark

Effect of Preoperative Intravenous High Dose Methylprednisolone on Quadriceps Muscle Function in Patients Scheduled for Total Knee-arthroplasty

This study evaluates the pathophysiological effects of a single dose Methylprednisolone administered prior to total knee-arthroplasty (TKA). The investigators examine the effect on thigh muscle function to evaluate the efficacy of Methylprednisolone on knee-extension strength at discharge after TKA.

Half of participants will receive intravenous Solu-Medrol 125 mg, while the other half will receive placebo.

The investigators hypothesize that the group receiving Methylprednisolone will experience smaller loss of knee-extension strength compared to the placebo-group, early after TKA.

Study Overview

Status

Completed

Conditions

Detailed Description

The anti-inflammatory effects of glucocorticoids are well known. The beneficial effects in postoperative pain, postoperative nausea and vomiting are well-documented.

Knee-arthroplasty surgery and the inflammatory stress response in general affect the potential of recovery. The quadriceps muscle strength is shown to be reduced significantly (80%) early after surgery. The mechanism is thought related to inhibitory reflexes and pain caused by surgical induced inflammation around the knee joint. The effect of glucocorticoids on the quadriceps muscle function after knee-arthroplasty surgery is unknown and calls for further investigation.

The study is to be considered as explorative.

The primary analysis of the primary outcome measure is a comparison of the changes in knee extension strength from baseline to 48 hours postoperatively between the two groups.

For calculation of sample size the average loss of strength from baseline (before surgery) to 48 hours after TKA-surgery being 0.8 Nm/kg body weight (SD=0.39, Holm et al. 2010), a risk of type I errors 5% and a risk of type II errors 20% (80% power) were used. The sample size is estimated to reveal a group difference in knee extension strength of minimum 40%.

The primary analysis is carried out on all included patients (intention-to-treat) with baseline values as covariate. Secondary exploratory per-protocol analysis might be performed. Missing outcomes will be analysed using multiple imputation due to expected strong time trends.

The secondary outcome measures; a group difference of 6 sec. (Timed Up & Go) and 2 cm (knee circumference) are considered clinically relevant. The statistical power is based on the calculation outlined above using the same test prerequisites.

For further details please also view the European Clinical Trials Database (EudraCT) registration:

EudraCT nr.: 2014-003395-23

Study Type

Interventional

Enrollment (Actual)

70

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Copenhagen NV, Denmark, 2400
        • Bispebjerg Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

55 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Osteoarthrosis
  • Undergoing total unilateral knee-arthroplasty surgery
  • Speak and understand Danish
  • Have given informed consent

Exclusion Criteria:

  • Revision, bilateral or uni chamber knee-arthroplasty surgery
  • General anaesthesia
  • Allergy or intolerance towards Methylprednisolone
  • Local or systemic infection
  • Permanent systemic treatment with steroids within 30 days preoperatively
  • Insulin-dependent diabetes
  • Active treatment of ulcer within 3 months preoperatively
  • Cancer disease
  • Autoimmune disease incl. rheumatoid arthritis
  • Pregnant or breast feeding women
  • Menopause <1 year

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Methylprednisolone
Preoperative single high dose of Solu-Medrol 125 mg iv.
Comparison of preoperative single high dose of Methylprednisolone 125 mg iv. and isotonic Sodium Chloride (placebo)
Other Names:
  • Solu-Medrol
Placebo Comparator: Isotonic Sodium Chloride
Preoperative single dose of isotonic Sodium Chloride.
Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in isometric knee extension strength measured as Nm/kg from baseline to 48 hours after surgery
Time Frame: two days after surgery
two days after surgery

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in Timed Up & Go (sec.) from baseline (before surgery) to 48 hours after surgery
Time Frame: two days after surgery
two days after surgery
Change in knee circumference (cm) from baseline (before surgery) to 48 hours after surgery
Time Frame: two days after surgery
two days after surgery
Change in pain intensity from baseline (before surgery) to 48 hours after surgery
Time Frame: two days after surgery
two days after surgery
Change in concentration of C-reactive Protein from baseline (before surgery) to 48 hours after surgery
Time Frame: two days after suregry
two days after suregry

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Collaborators

Investigators

  • Principal Investigator: Viktoria Lindberg-Larsen, MD, Section for Surgical Pathophysiology, Rigshospitalet

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2015

Primary Completion (Actual)

April 1, 2016

Study Completion (Actual)

April 1, 2016

Study Registration Dates

First Submitted

December 8, 2014

First Submitted That Met QC Criteria

December 17, 2014

First Posted (Estimate)

December 18, 2014

Study Record Updates

Last Update Posted (Estimate)

April 8, 2016

Last Update Submitted That Met QC Criteria

April 7, 2016

Last Verified

April 1, 2016

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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