Do Corticosteroid Injections During Total Knee Replacement Improve Early Clinical Results?

NCT00492973 | Completed Results

• 1 other identifier: LCO.2006.2
• Study Type: interventional
• Target: 101
• Locations: 1 country
• Sites: 1

Brief Summary

Prior to surgery, a pharmacist will randomly assign participating patients to one of two groups. One group will get an injection in the knee during surgery that contains medications to limit pain and an antibiotic. A second group will get an injection in the knee during surgery that contains the same pain medications and antibiotic along with a corticosteroid to control inflammation. Corticosteroids are anti-inflammatory medications, not to be confused with muscle-building anabolic steroids you may have heard about in the news. Each patient will have an equal chance of being in either of the two groups. This study will test the safety and efficacy of methylprednisolone acetate in the treatment of pain and inflammation following total knee replacement.

Conditions

Osteoarthritis; Post-traumatic; Arthrosis

Keywords

arthroplasty; replacement; knee

Outcome Measures

Primary Outcomes (6)

• Length of Hospital Stay

  days after surgery

• Knee Range of Motion

  3 months

• Knee Society Scores

  The Knee Society Score is on a scale of 0 to 100, with 0 being the worst possible score, and 100 being the best possible score. The Knee Society Score takes into account subjective patient reports of pain and functional ability as well as clinical measures of passive knee range of motion.

  3 months postoperative

• Amount of Pain Medication Taken Per Day

  Average of 3 days after surgery

• Patient Satisfaction

  6 weeks, 3 months, and 1 year postoperative

• Complications, Such as Infections, Hospital Readmissions, Manipulations Under Anesthesia, Etc.

  any point during the first postoperative year

Study Arms (2)

Control

ACTIVE COMPARATOR

Patients in the active comparator group will receive intraoperative injections containing bupivacaine HCl, morphine, epinephrine, clonidine, cefuroxime, and normal saline, as per the surgeon's standard of care.

Drug: active comparator

Corticosteroid

EXPERIMENTAL

Patients in the Corticosteroid group will have the same medications as the Control Group with the addition of a corticosteroid (methylprednisolone acetate)

Drug: methylprednisolone acetate

Interventions

methylprednisolone acetate DRUG

Same medications and doses as the active comparator, but with the addition of 40 mg of methylprednisolone acetate

Corticosteroid

active comparator DRUG

bupivacaine HCl 80 mg, morphine 4 mg, epinephrine 300 micrograms, clonidine 100 micrograms, cefuroxime 750 mg, and normal saline

Also known as: bupivacaine HCl, morphine, epinephrine, clonidine, cefuroxime, normal saline

Control

Eligibility Criteria

• Age: 18 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Between ages of 18 and 95
• Has elected to undergo total knee replacement

You may not qualify if:

• Allergy to any of the medications used in the protocol
• History of kidney disease
• Rheumatoid arthritis
• Any systemic conditions associated with chronic pain
• History of deep knee sepsis in the affected extremity
• Unable to understand the questions used to obtain the Knee Society Score
• Minors and prisoners will be excluded from the study

Sponsors & Collaborators

• New Lexington Clinic: lead
• St. Joseph's Health Care London: collaborator

Study Sites (1)

Lexington Clinic Sports Medicine Center

Lexington, Kentucky, 40504, United States

Location

Related Publications (3)

• Lombardi AV Jr, Berend KR, Mallory TH, Dodds KL, Adams JB. Soft tissue and intra-articular injection of bupivacaine, epinephrine, and morphine has a beneficial effect after total knee arthroplasty. Clin Orthop Relat Res. 2004 Nov;(428):125-30. doi: 10.1097/01.blo.0000147701.24029.cc.

  PMID: 15534532 BACKGROUND

• Parvataneni HK, Ranawat AS, Ranawat CS. The use of local periarticular injections in the management of postoperative pain after total hip and knee replacement: a multimodal approach. Instr Course Lect. 2007;56:125-31.

  PMID: 17472300 BACKGROUND

• Christensen CP, Jacobs CA, Jennings HR. Effect of periarticular corticosteroid injections during total knee arthroplasty. A double-blind randomized trial. J Bone Joint Surg Am. 2009 Nov;91(11):2550-5. doi: 10.2106/JBJS.H.01501.

  PMID: 19884426 DERIVED

MeSH Terms

Conditions

Osteoarthritis

Interventions

Methylprednisolone Acetate; Bupivacaine; Morphine; Epinephrine; Clonidine; Cefuroxime; Saline Solution

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Methylprednisolone; Prednisolone; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Ethanolamines; Amino Alcohols; Alcohols; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Imidazolines; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Cephalosporins; beta-Lactams; Lactams; Thiazines; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Limitations and Caveats

One patient died 25 days after the surgery as a result of complications associated with deep knee joint sepsis.

Results Point of Contact

• Title: Cale Jacobs, PhD
• Organization: Lexington Clinic

cjaco@lexclin.com

859-258-8238

Study Officials

• Christian P Christensen, MD

  New Lexington Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 25, 2007
• First Posted: June 27, 2007
• Study Start: March 1, 2006
• Primary Completion: February 1, 2008
• Study Completion: February 1, 2008
• Last Updated: December 19, 2013
• Results First Posted: December 19, 2013

Record last verified: 2013-04

Locations

US (1)