Ketorolac Versus Triamcinolone Knee Injections for Osteoarthritis
Information source: San Antonio Military Medical Center
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Knee Osteoarthritis
Intervention: Ketorolac Tromethamine (Drug); Triamcinolone Acetonide (Drug)
Phase: N/A
Status: Completed
Sponsored by: San Antonio Military Medical Center Official(s) and/or principal investigator(s): Siraj Sayeed, MD, Principal Investigator, Affiliation: San Antonio Military Medical Center
Summary
Osteoarthritis is a disabling disease of the joint spaces and has a high impact on society
due to the amount of people who are affected by the disease. Nonoperative management is a
mainstay of therapy in most patients. Ketorolac tromethamine and triamcinolone acetonide
intra-articular knee injections will be compared in a prospective, double-blinded,
randomized trial in subjects with knee osteoarthritis. Subjects will be enrolled from the
Orthopaedics Clinic based on inclusion and exclusion criteria. Intra-articular knee
injection of ketorolac tromethamine or triamcinolone acetonide will be performed under
ultrasound guidance. Multiple outcome measures will be performed throughout the six month
period of follow-up. The investigators predict ketorolac tromethamine will have a longer
duration of pain relief when compared to triamcinolone acetonide. The investigators predict
there will be no differences between the two intra-articular knee injections in terms of
function using validated scoring instruments.
Clinical Details
Official title: Ketorolac Versus Triamcinolone Intra-articular Knee Injections for the Treatment of Osteoarthritis. A Prospective, Double-Blinded Randomized Trial
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Change in Visual analogue scale (VAS)
Secondary outcome: Change in Western Ontario and McMaster Universities Index (WOMAC)Change in Knee Society Score (KSS) Change in Tegner-Lysholm Knee Score (TLK) Change in Short Form (SF-36)
Detailed description:
Subject Population: Adult patients, age 18-90 years old who satisfy the inclusion criteria
and do not meet the exclusion criteria will be enrolled from the Orthopaedics Clinic at San
Antonio Military Medical Center (SAMMC). The enrollment period for this study is two years,
patients will be recruited up to 44 enrollees to allow 36 completers. Patients will be
stratified based on gender and age (< 65 or >= 65 years old). Demographics obtained will be
age, gender, height, weight, laterality and body-mass index (BMI).
Randomization: This will be a predetermined computerized randomization schedule to identify
treatment, ketorolac tromethamine versus triamcinolone acetonide. A patient key on paper
listing the patient name, last four digits of sponsor's social security number, study number
(randomly assigned), and treatment will be kept with the nurse/technician in the
Orthopaedics Clinic, locked in a cabinet. Patients will be stratified by gender and age (<
65 or >= 65 years old). Subjects will continue to be enrolled until there are at least 10 of
each gender in each group, treated with either ketorolac tromethamine or triamcinolone
acetonide. In the event the subject has bilateral knee pain, both knees will be injected
with the same treatment medication and the knee will be randomized as to which one will be
included in the data analysis.
A pharmacist will prepare the treatment injection in the Orthopaedics Clinic. Injections
will be done with a 2-inch, 21-gauge needle placed on a 10cc syringe with an opaque covering
to conceal its contents to blind the patient and associate investigator to treatment.
Injections will contain either 2cc of ketorolac tromethamine (Toradol, 15mg/cc) in 8cc of
bupivacaine hydrochloride (0. 5%) without epinephrine or 2cc of triamcinolone acetonide
(Kenalog-40, 40mg/cc) in 8cc of bupivacaine hydrochloride (0. 5%) without epinephrine. The
subject and the treatment injection will be taken to the Interdisciplinary Pain Management
Center, for injection under ultrasound guidance. The subject's selected knee, or bilateral
knees, at the superolateral site, will be sterilely prepped in standard fashion with
betadine and allowed to dry, prior to injection. The treatment will be injected by the
associate investigator, in the Interdisciplinary Pain Management Center, who is trained in
Physical Medicine and Rehabilitation and certified to perform ultrasound examinations. The
associate investigator will be blinded to treatment and outcomes.
A patient key listing the patient name, last four digits of sponsor's social security
number, age, gender, patient number (randomly assigned) and treatment received will be kept
with the nurse/technician in the Orthopaedics Clinic in a research folder, locked in a
cabinet.
Radiographs will be obtained at baseline and at 6 months follow-up. Osteoarthritis will be
classified according to Kellgren-Lawrence (K-L) radiographic criteria by associate
investigator who is fellowship trained in Total Joints. K-L grading will be entered on the
Case Report Form (CRF) prior to outcome data entry. The associate investigator will be
blinded to treatment. Outcome data collection will be performed by a study nurse/technician
in the Orthopaedics Clinic, with the exception of part of the Knee Society Score (KSS),
which will be performed by an associate investigator. The nurse/technician will record
demographic data, including height, weight, BMI, gender, laterality and age, at the baseline
clinic visit and at the 6 month follow-up. The use of nonsteroidal anti-inflammatory drug
(NSAID) and analgesic drugs and adverse events during the study period will be recorded at
each visit. Patients will keep a diary of NSAID and analgesic use during the study. Patients
will follow-up at 2 weeks, 6 weeks, 3 months and 6 months. A visual analogue scale (VAS),
KSS, Western Ontario and McMasters Universities (WOMAC) index, Short Form 36 (SF-36),
University California Los Angeles (UCLA) Activity Score and Lysholm Knee Score (LKS) will be
obtained at the baseline clinic visit and each follow-up. All data obtained from the study
will be recorded on the CRF. All data collected will be kept with the nurse/technician in
the Orthopaedics Clinic in a research folder, locked in a cabinet.
Data from the CRF will be entered into an electronic database on Excel by the principle
investigator on a password protected computer. The database will be made available to the
associate investigators electronically. Data analysis will be performed by the principle
investigator which will also be performed on a password protected computer. All
investigators will remain blinded to the treatment received, until all data analysis is
performed. There will be no patient identifiers in the data provided to the investigators,
only the patient number. The patient number is a number randomly assigned to the patient and
is only identifiable in the patient key, which will be kept separate as above.
A sample size of 16 per group achieve 80% power to detect a difference of 1. 6 (16mm) VAS
comparing ketorolac tromethamine to triamcinolone acetonide intra-articular injections with
estimated standard deviations of 1. 56 and with a significance level (alpha) of 0. 05. There
is an expected drop-out rate of 20%, which implies a sample size of 20 subjects per group.
Data analysis will be performed by the principle investigator and associate investigator who
will be blinded to treatment until data analysis is complete.
Eligibility
Minimum age: 18 Years.
Maximum age: 90 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Subject must be at least 18 years of age and no older than 90 years of age; of either
gender
- Radiographic evidence of symptomatic osteoarthritis in one or bilateral knees.
Osteoarthritis will be defined as pain with weight-bearing at the tibiofemoral and/or
patellofemoral articulation together with radiographic findings as described below.
At the painful articulation, radiographic evidence of Kellgren-Lawrence
- Grade 2: definite osteophytes and possible narrowing of joint cartilage associated
with sclerosis of subchondral bone or,
- Grade 3: moderate multiple osteophytes, definite narrowing of the joint space, small
pseudocystic areas with sclerotic walls in the subchondral bone, possible deformity
of bone ends or,
- Grade 4: large osteophytes, marked narrowing of joint space, severe sclerosis and
altered shape of the bone ends.
Subject agrees to participate in follow-up evaluations and complete outcome score sheets
(post-injection, 2 weeks, 6 weeks, 3 months and 6 months).
Exclusion Criteria:
- Any inflammatory or neuropathic arthropathy
- Insufficiency of the collateral ligaments or cruciate ligaments
- Current infection
- Recent injection (<3 months)
- Pregnant/lactating (β-human chorionic gonadotropin pregnancy test will be completed
prior to injection)
- Allergy or hypersensitivity to the study medications
- Currently taking any anti-coagulation medications
- Subject is unable to make his/her own decision regarding the informed consent
- Subject is unable to read/understand English
Locations and Contacts
Additional Information
Starting date: January 2013
Last updated: November 19, 2014
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