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Ketorolac Versus Triamcinolone Knee Injections for Osteoarthritis

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ClinicalTrials.gov Identifier: NCT02295189
Recruitment Status : Completed
First Posted : November 20, 2014
Last Update Posted : November 20, 2014
Sponsor:
Information provided by (Responsible Party):
Jaime L. Bellamy, DO, San Antonio Military Medical Center

Brief 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.

Condition or disease Intervention/treatment Phase
Knee Osteoarthritis Drug: Ketorolac Tromethamine Drug: Triamcinolone Acetonide Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Ketorolac Versus Triamcinolone Intra-articular Knee Injections for the Treatment of Osteoarthritis. A Prospective, Double-Blinded Randomized Trial
Study Start Date : January 2013
Actual Primary Completion Date : May 2014
Actual Study Completion Date : June 2014


Arm Intervention/treatment
Active Comparator: Visual analogue scale
visual analogue scale versus triamcinolone acetonide visual analogue scale versus ketorolac tromethamine
Drug: Ketorolac Tromethamine
anti-inflammatory injection
Other Name: Toradol

Drug: Triamcinolone Acetonide
corticosteroid injection
Other Name: Kenalog

Active Comparator: Treatment
visual analogue scale versus triamcinolone acetonide visual analogue scale versus ketorolac tromethamine
Drug: Ketorolac Tromethamine
anti-inflammatory injection
Other Name: Toradol

Drug: Triamcinolone Acetonide
corticosteroid injection
Other Name: Kenalog




Primary Outcome Measures :
  1. Change in Visual analogue scale (VAS) [ Time Frame: Baseline, 2 weeks, 6 weeks, 3 months, 6 months ]

Secondary Outcome Measures :
  1. Change in Western Ontario and McMaster Universities Index (WOMAC) [ Time Frame: Baseline, 2 weeks, 6 weeks, 3 months, 6 months ]
  2. Change in Knee Society Score (KSS) [ Time Frame: Baseline, 2 weeks, 6 weeks, 3 months, 6 months ]
  3. Change in Tegner-Lysholm Knee Score (TLK) [ Time Frame: Baseline, 2 weeks, 6 weeks, 3 months, 6 months ]
  4. Change in Short Form (SF-36) [ Time Frame: Baseline, 2 weeks, 6 weeks, 3 months, 6 months ]


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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

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): NCT02295189


Sponsors and Collaborators
San Antonio Military Medical Center
Investigators
Principal Investigator: Siraj Sayeed, MD San Antonio Military Medical Center

Responsible Party: Jaime L. Bellamy, DO, Orthopaedic Resident Physician, San Antonio Military Medical Center
ClinicalTrials.gov Identifier: NCT02295189     History of Changes
Other Study ID Numbers: SanAntonioMMC
First Posted: November 20, 2014    Key Record Dates
Last Update Posted: November 20, 2014
Last Verified: November 2014

Additional relevant MeSH terms:
Ketorolac
Ketorolac Tromethamine
Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Triamcinolone hexacetonide
Triamcinolone
Triamcinolone Acetonide
Triamcinolone diacetate
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Immunosuppressive Agents
Immunologic Factors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors