Knee Osteoarthritis Clinical Trial
Official title:
A Double-blind, Randomized, Controlled, Equivalence Study Comparing Intra-articular Corticosteroid to Intra-articular Ketorolac Knee Injections
This study will compare the efficacy of intra-articular betamethasone injection to intra-articular ketorolac injection for symptomatic treatment of knee osteoarthritis in an equivalence study using a double-blinded, randomized, controlled design. Patients will be recruited from orthopaedic clinics at St. Luke's University Health Network. A total of 448 patients will be recruited (224 in each group) to receive an administration of an intra-articular betamethasone or ketorolac injection. The primary outcome is change in pain as assessed by the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score. Secondary outcomes include Knee Injury and Osteoarthritis Outcome (KOOS) and Knee Outcome Survey - Activities of Daily Living (KOS-ADL) scores and physical exam findings. Statistical analyses include repeated measures analysis of variance (ANOVA) (primary outcome) and selected ANOVA and nonparametric tests as deemed appropriate (secondary outcomes), with p < .05 denoting significance for all comparisons, and no adjustment for multiple testing.
Status | Recruiting |
Enrollment | 448 |
Est. completion date | October 2017 |
Est. primary completion date | October 2017 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Male |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Knee osteoarthritis as demonstrated on x-ray as Kellgren-Lawrence stage II or higher (Kellgren & Lawrence, 1957) - Clinical symptoms and physical exam consistent with osteoarthritis Exclusion Criteria: - Prior treatment with corticosteroid injections within the last 1 year - Failure of past treatment with corticosteroid injections - Medical treatment including oral medication, physical therapy, or other analgesia use within the last 20 days prior to injection - Pregnant - Under 18 - Serious systemic disease - Gout arthropathy - Inflammatory joint disease including rheumatoid or psoriatic arthritis - Metabolic bone disease - Anserine bursitis or pain referred from other structures such as ipsilateral hip or lumbar spine - Patients with a significant effusion that requires aspiration |
Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | St Luke's Health and University Network | Bethlehem | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
St. Luke's Hospital, Pennsylvania |
United States,
Calmet J, Esteve C, Boada S, Giné J. Analgesic effect of intra-articular ketorolac in knee arthroscopy: comparison of morphine and bupivacaine. Knee Surg Sports Traumatol Arthrosc. 2004 Nov;12(6):552-5. Epub 2004 Jun 9. — View Citation
Collins NJ, Misra D, Felson DT, Crossley KM, Roos EM. Measures of knee function: International Knee Documentation Committee (IKDC) Subjective Knee Evaluation Form, Knee Injury and Osteoarthritis Outcome Score (KOOS), Knee Injury and Osteoarthritis Outcome Score Physical Function Short Form (KOOS-PS), Knee Outcome Survey Activities of Daily Living Scale (KOS-ADL), Lysholm Knee Scoring Scale, Oxford Knee Score (OKS), Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), Activity Rating Scale (ARS), and Tegner Activity Score (TAS). Arthritis Care Res (Hoboken). 2011 Nov;63 Suppl 11:S208-28. doi: 10.1002/acr.20632. Review. — View Citation
Karthikeyan S, Kwong HT, Upadhyay PK, Parsons N, Drew SJ, Griffin D. A double-blind randomised controlled study comparing subacromial injection of tenoxicam or methylprednisolone in patients with subacromial impingement. J Bone Joint Surg Br. 2010 Jan;92(1):77-82. doi: 10.1302/0301-620X.92B1.22137. — View Citation
KELLGREN JH, LAWRENCE JS. Radiological assessment of osteo-arthrosis. Ann Rheum Dis. 1957 Dec;16(4):494-502. — View Citation
Maricar N, Parkes MJ, Callaghan MJ, Felson DT, O'Neill TW. Where and how to inject the knee--a systematic review. Semin Arthritis Rheum. 2013 Oct;43(2):195-203. doi: 10.1016/j.semarthrit.2013.04.010. Review. Erratum in: Semin Arthritis Rheum. 2015 Apr;44(5):e18. — View Citation
Min KS, St Pierre P, Ryan PM, Marchant BG, Wilson CJ, Arrington ED. A double-blind randomized controlled trial comparing the effects of subacromial injection with corticosteroid versus NSAID in patients with shoulder impingement syndrome. J Shoulder Elbow Surg. 2013 May;22(5):595-601. doi: 10.1016/j.jse.2012.08.026. Epub 2012 Nov 22. — View Citation
Oztuna V, Eskandari M, Bugdayci R, Kuyurtar F. Intra-articular injection of tenoxicam in osteoarthritic knee joints with effusion. Orthopedics. 2007 Dec;30(12):1039-42. — View Citation
Reuben SS, Connelly NR. Postoperative analgesia for outpatient arthroscopic knee sugery with intraarticular bupivacaine and ketorolac. Anesth Analg. 1995 Jun;80(6):1154-7. — View Citation
Stålman A, Tsai JA, Segerdahl M, Dungner E, Arner P, Felländer-Tsai L. Ketorolac but not morphine exerts inflammatory and metabolic effects in synovial membrane after knee arthroscopy: a double-blind randomized prospective study using the microdialysis technique. Reg Anesth Pain Med. 2009 Nov-Dec;34(6):557-64. — View Citation
Unlu Z, Ay K, Tuzun C. Comparison of intra-articular tenoxicam and oral tenoxicam for pain and physical functioning in osteoarthritis of the knee. Clin Rheumatol. 2006 Feb;25(1):54-61. Epub 2005 Oct 15. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) | Determination of patient's function and pain following intra-articular drug administration | Follow up at 1 month | No |
Secondary | Knee injury and Osteoarthritis Outcome Score score | Determination of patient's function and pain following intra-articular drug administration | Follow up at 1, 3 and 6 months | No |
Secondary | Knee Outcome Survey Activities of Daily Living Scale (KOS-ADL) scale | Determination of patient's function and pain following intra-articular drug administration | Follow up at 1, 3 and 6 months | No |
Secondary | Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) | Determination of patient's function and pain following intra-articular drug administration | Follow up at 3 months | No |
Secondary | Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) | Determination of patient's function and pain following intra-articular drug administration | Follow up at 6 months | No |
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