Ketorolac Versus Triamcinolone Knee Injections for Osteoarthritis
Condition: Knee Osteoarthritis
MeSH terms: Osteoarthritis
Study type: Interventional

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.
    

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.
    

Intervention name(s): Ketorolac Tromethamine; Triamcinolone Acetonide
Intervention type(s): Drug; Drug
Intervention description(s): anti-inflammatory injection; corticosteroid injection
Other intervention name(s): Toradol; Kenalog
Intervention MeSH terms: Triamcinolone; Triamcinolone Acetonide; Triamcinolone hexacetonide; Ketorolac; Ketorolac Tromethamine; Triamcinolone diacetate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment