Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02319343
Recruitment Status : Completed
First Posted : December 18, 2014
Last Update Posted : April 8, 2016
Sponsor:
Collaborator:
Bispebjerg Hospital
Information provided by (Responsible Party):
Viktoria Oline Lindberg-Larsen, Rigshospitalet, Denmark

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Osteoarthrosis Drug: Methylprednisolone Drug: Isotonic Sodium Chloride Phase 3

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


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Official Title: Effect of Preoperative Intravenous High Dose Methylprednisolone on Quadriceps Muscle Function in Patients Scheduled for Total Knee-arthroplasty
Study Start Date : January 2015
Actual Primary Completion Date : April 2016
Actual Study Completion Date : April 2016


Arm Intervention/treatment
Active Comparator: Methylprednisolone
Preoperative single high dose of Solu-Medrol 125 mg iv.
Drug: Methylprednisolone
Comparison of preoperative single high dose of Methylprednisolone 125 mg iv. and isotonic Sodium Chloride (placebo)
Other Name: Solu-Medrol

Placebo Comparator: Isotonic Sodium Chloride
Preoperative single dose of isotonic Sodium Chloride.
Drug: Isotonic Sodium Chloride
Placebo




Primary Outcome Measures :
  1. Change in isometric knee extension strength measured as Nm/kg from baseline to 48 hours after surgery [ Time Frame: two days after surgery ]

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


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   55 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02319343


Locations
Layout table for location information
Denmark
Bispebjerg Hospital
Copenhagen NV, Denmark, 2400
Sponsors and Collaborators
Rigshospitalet, Denmark
Bispebjerg Hospital
Investigators
Layout table for investigator information
Principal Investigator: Viktoria Lindberg-Larsen, MD Section for Surgical Pathophysiology, Rigshospitalet

Publications of Results:
Other Publications:

Layout table for additonal information
Responsible Party: Viktoria Oline Lindberg-Larsen, MD, research assistant, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT02319343     History of Changes
Other Study ID Numbers: HK_VL_08_2014
First Posted: December 18, 2014    Key Record Dates
Last Update Posted: April 8, 2016
Last Verified: April 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Viktoria Oline Lindberg-Larsen, Rigshospitalet, Denmark:
Glucocorticoid
Quadriceps muscle function
Knee arthroplasty, total

Additional relevant MeSH terms:
Layout table for MeSH terms
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Methylprednisolone
Methylprednisolone Acetate
Methylprednisolone Hemisuccinate
Prednisolone
Prednisolone acetate
Prednisolone hemisuccinate
Prednisolone phosphate
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Neuroprotective Agents
Protective Agents
Antineoplastic Agents, Hormonal
Antineoplastic Agents