Intra-articular Injections for Knee Osteoarthritis: A Single Blinded Prospective Randomized Trial

NCT02995083 | Withdrawn Early Phase 1 FDA Drug

• 1 other identifier: 16090902
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

To investigate the clinical benefit of intra-articular injections of saline in patients with symptomatic osteoarthritis of the knee and compare the clinical response of saline to the current standard treatment with corticosteroids and an air injection placebo.

Conditions

Symptomatic Osteoarthritis of the Knee

Keywords

osteoarthritis

Outcome Measures

Primary Outcomes (1)

• Mean change in Western Ontario and McMaster Universities Arthritis Index score (WOMAC)

  Mean change in the WOMAC Index score from baseline score

  12 weeks after injection

Secondary Outcomes (6)

• Mean change in Knee injury and Osteoarthritis Outcome Score (KOOS)

  12 weeks after injection

• Mean change in International Knee Documentation Committee (IKDC) score

  12 weeks after injection

• Mean change in Visual Analogue Scale (VAS)

  12 weeks after injection

• Mean change in Short Form 12 (SF-12) score

  12 weeks after injection

• Mean change in The Lysholm Knee score

  12 weeks after injection

Study Arms (3)

Knee injection with corticosteroids

ACTIVE COMPARATOR

Using clinically accepted methods, subjects will undergo a palpation guided injection of corticosteroids into the knee joint. Subjects will then return for follow-up visit at 12 weeks for a physical exam of the knee. Patients will fill out questionnaires online at 1, 6, 12 and 24 weeks.

Drug: 40 mg Depo-Medrol in 1 ml, 9 ml of 1% lidocaine

Knee injection with saline

PLACEBO COMPARATOR

Using clinically accepted methods, subjects will undergo a palpation guided injection of saline into the knee joint. Subjects will then return for follow-up visit at 12 weeks for a physical exam of the knee. Patients will fill out questionnaires online at 1, 6, 12 and 24 weeks.

Drug: Normal Saline 10 ml

Knee injection with air

SHAM COMPARATOR

Using clinically accepted methods, subjects will undergo a palpation guided injection of air into the knee joint. Subjects will then return for follow-up visit at 12 weeks for a physical exam of the knee. Patients will fill out questionnaires online at 1, 6, 12 and 24 weeks.

Drug: Air 10 ml

Interventions

40 mg Depo-Medrol in 1 ml, 9 ml of 1% lidocaine DRUG

Patients will receive an ultrasound guided intra-articular injection of 40 mg Depo-Medrol in 1 ml, 9 ml of 1% lidocaine

Also known as: Corticosteroid

Knee injection with corticosteroids

Normal Saline 10 ml DRUG

Patients will receive an ultrasound guided intra-articular injection of Normal Saline 10 ml

Also known as: Saline

Knee injection with saline

Air 10 ml DRUG

Patients will receive an ultrasound guided intra-articular injection of Air 10 ml

Also known as: Air

Knee injection with air

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The patient must be between the ages of 18 and 80
• Informed consent has been obtained from the patient
• The patient must have diagnosed symptomatic osteoarthritis of the tibio-femoral or patello-femoral compartment of the target knee for at least 1 month
• The patient has moderate-to-severe knee pain reflected by an average visual analogue scale (VAS) score of 4 or greater (out of a possible 10) over the previous 7 days.
• Radiographic imaging must show grade II-III osteoarthritis on the Kellgren \& Lawrence Scale.
• Patients may have bilateral osteoarthritis but only patients with unilateral symptoms may be included.

You may not qualify if:

• Knee instability
• A score less than 4 (out of a possible 10) on their intake VAS
• Major axial deviation (\>5º valgus or varus deviation as evidenced on a standard of care x-ray.
• Previous surgery at the target knee \< 6 months.
• Symptomatic osteoarthritis of the contralateral knee or any other joint.
• Systemic or intra articular injection to any joint with corticosteroids within 6 months prior to screening
• Previous joint injection of any type in the past 6 months
• Systemic conditions that could interfere with outcome such as Rheumatoid arthritis, coagulopathy, and anemia.
• Allergy to any of the injected substances.
• Any patient unable to cease NSAID usage (other than low dose aspirin) due to unrelated condition.
• Cognitive impairment or unable to provide informed consent
• Recent knee trauma with violation of the intra-articular bone.

Sponsors & Collaborators

• Rush University Medical Center: lead

Related Publications (6)

• Murphy L, Schwartz TA, Helmick CG, Renner JB, Tudor G, Koch G, Dragomir A, Kalsbeek WD, Luta G, Jordan JM. Lifetime risk of symptomatic knee osteoarthritis. Arthritis Rheum. 2008 Sep 15;59(9):1207-13. doi: 10.1002/art.24021.

  PMID: 18759314 BACKGROUND

• Altman RD, Devji T, Bhandari M, Fierlinger A, Niazi F, Christensen R. Clinical benefit of intra-articular saline as a comparator in clinical trials of knee osteoarthritis treatments: A systematic review and meta-analysis of randomized trials. Semin Arthritis Rheum. 2016 Oct;46(2):151-159. doi: 10.1016/j.semarthrit.2016.04.003. Epub 2016 Apr 27.

  PMID: 27238876 BACKGROUND

• Williams VJ, Piva SR, Irrgang JJ, Crossley C, Fitzgerald GK. Comparison of reliability and responsiveness of patient-reported clinical outcome measures in knee osteoarthritis rehabilitation. J Orthop Sports Phys Ther. 2012 Aug;42(8):716-23. doi: 10.2519/jospt.2012.4038. Epub 2012 Mar 8.

  PMID: 22402677 BACKGROUND

• Kim J, Seo BS. How to calculate sample size and why. Clin Orthop Surg. 2013 Sep;5(3):235-42. doi: 10.4055/cios.2013.5.3.235. Epub 2013 Aug 20.

  PMID: 24009911 BACKGROUND

• Zhang W, Robertson J, Jones AC, Dieppe PA, Doherty M. The placebo effect and its determinants in osteoarthritis: meta-analysis of randomised controlled trials. Ann Rheum Dis. 2008 Dec;67(12):1716-23. doi: 10.1136/ard.2008.092015. Epub 2008 Jun 9.

  PMID: 18541604 BACKGROUND

• Eker HE, Cok OY, Aribogan A, Arslan G. The efficacy of intra-articular lidocaine administration in chronic knee pain due to osteoarthritis: A randomized, double-blind, controlled study. Anaesth Crit Care Pain Med. 2017 Apr;36(2):109-114. doi: 10.1016/j.accpm.2016.05.003. Epub 2016 Jul 30.

  PMID: 27485803 BACKGROUND

MeSH Terms

Conditions

Osteoarthritis

Interventions

Methylprednisolone Acetate; Lidocaine; Adrenal Cortex Hormones; Saline Solution; Sodium Chloride; Air

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Methylprednisolone; Prednisolone; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds; Atmosphere; Environment; Ecological and Environmental Phenomena; Biological Phenomena; Meteorological Concepts; Environment and Public Health

Study Officials

• Nikhil N Verma, MD

  Midwest Orthopaedics at Rush University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Certified Principal Investigator, Research Administrator

Study Record Dates

• First Submitted: December 14, 2016
• First Posted: December 16, 2016
• Study Start: June 1, 2017
• Primary Completion: January 1, 2018
• Study Completion: January 1, 2018
• Last Updated: December 18, 2017

Record last verified: 2017-12

Data Sharing

• IPD Sharing: Will not share