Ketorolac Versus Triamcinolone Knee Injections for Osteoarthritis

NCT02295189 | Completed

• 1 other identifier: SanAntonioMMC
• Study Type: interventional
• Target: 36
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Knee Osteoarthritis

Outcome Measures

Primary Outcomes (1)

• Change in Visual analogue scale (VAS)

  Baseline, 2 weeks, 6 weeks, 3 months, 6 months

Secondary Outcomes (4)

• Change in Western Ontario and McMaster Universities Index (WOMAC)

  Baseline, 2 weeks, 6 weeks, 3 months, 6 months

• Change in Knee Society Score (KSS)

  Baseline, 2 weeks, 6 weeks, 3 months, 6 months

• Change in Tegner-Lysholm Knee Score (TLK)

  Baseline, 2 weeks, 6 weeks, 3 months, 6 months

• Change in Short Form (SF-36)

  Baseline, 2 weeks, 6 weeks, 3 months, 6 months

Study Arms (2)

Visual analogue scale

ACTIVE COMPARATOR

visual analogue scale versus triamcinolone acetonide visual analogue scale versus ketorolac tromethamine

Drug: Ketorolac Tromethamine; Drug: Triamcinolone Acetonide

Treatment

ACTIVE COMPARATOR

visual analogue scale versus triamcinolone acetonide visual analogue scale versus ketorolac tromethamine

Drug: Ketorolac Tromethamine; Drug: Triamcinolone Acetonide

Interventions

Ketorolac Tromethamine DRUG

anti-inflammatory injection

Also known as: Toradol

Treatment; Visual analogue scale

Triamcinolone Acetonide DRUG

corticosteroid injection

Also known as: Kenalog

Treatment; Visual analogue scale

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• San Antonio Military Medical Center: lead

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Ketorolac Tromethamine; Triamcinolone Acetonide

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Indomethacin; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Triamcinolone; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• Siraj Sayeed, MD

  San Antonio Military Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Orthopaedic Resident Physician

Study Record Dates

• First Submitted: November 12, 2014
• First Posted: November 20, 2014
• Study Start: January 1, 2013
• Primary Completion: May 1, 2014
• Study Completion: June 1, 2014
• Last Updated: November 20, 2014

Record last verified: 2014-11