Corticosteroid/Ropivacaine Versus Corticosteroid/Saline Injections for Knee Osteoarthritis

NCT02576249 | Completed Phase 4 Results FDA Drug

• 1 other identifier: 15-003120
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

Brief Summary

Corticosteroid injections are commonly used for the symptomatic treatment of knee osteoarthritis. Common practice is to inject the joint with a combination of corticosteroid and local anesthetic, with the rationale of providing longer duration pain relief with the corticosteroid and immediate, though short duration relief with the anesthetic. However, multiple in vitro and animal studies have shown that local anesthetic may be harmful to chondrocytes. Despite this data, use of intra-articular anesthetic remains widespread. Many clinicians believe incorporating the anesthetic is important because it can provide immediate pain relief and facilitate patient confidence in the treatment program. However, there is no published data to validate this reasoning. Therefore, the anesthetic has unknown clinical benefit and may have adverse effects on articular cartilage. In light of this, the investigators question the routine use of anesthetics in joint injections. The purpose of this study is to compare the effects of knee joint injections using: 1) corticosteroid with local anesthetic versus 2) corticosteroid with normal saline.

Conditions

Osteoarthritis

Keywords

osteoarthritis; injection; steroid; anesthetic

Outcome Measures

Primary Outcomes (1)

• The Knee Osteoarthritis Outcome Score (KOOS) Pain Subscale

  The KOOS holds 42 items in five separately scored subscales: Pain, other Symptoms, Function in daily living (ADL), Function in Sport and Recreation (Sport/Rec), and knee-related Quality of Life (QOL). A Likert scale is used and all items have five possible answer options scored from 0 (No Problems) to 4 (Extreme Problems) and each of the five scores is calculated as the sum of the items included. Scores are transformed to a 0-100 scale, with zero representing extreme knee problems and 100 representing no knee problems.

  3 months after the injection

Secondary Outcomes (2)

• Pain Scale Score

  Pre-injection, immediately post-injection, 2 weeks, 3 months

• Tegner Activity Level Scale

  baseline (pre-injection), 2 weeks, 3 months

Study Arms (2)

Ropivacaine and Methylprednisolone

ACTIVE COMPARATOR

0.2% ropivacaine and methylprednisolone knee joint injection

Drug: Ropivacaine; Drug: Methylprednisolone

Saline and Methylprednisolone

EXPERIMENTAL

0.9% normal saline and methylprednisolone knee joint injection

Drug: Normal saline; Drug: Methylprednisolone

Interventions

Ropivacaine DRUG

4cc 0.5% ropivacaine

Also known as: Naropin

Ropivacaine and Methylprednisolone

Normal saline DRUG

4cc of sterile normal saline (0.9%)

Also known as: Sodium Chloride

Saline and Methylprednisolone

Methylprednisolone DRUG

1cc 40mg methylprednisolone

Also known as: Depo-Medrol

Ropivacaine and Methylprednisolone; Saline and Methylprednisolone

Eligibility Criteria

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

You may qualify if:

• Age 18 or older
• Knee osteoarthritis (uni- or bilateral) as defined by the American College of Rheumatology (staged by Kellgren-Lawrence radiographic grading scale)

You may not qualify if:

• Rheumatologic/inflammatory disease
• Metabolic bone disease
• Crystalline arthropathy
• Current smoking
• BMI \> 40
• Knee injection with corticosteroid or viscosupplementation within previous 6 months
• History of knee prolotherapy, platelet rich plasma or cellular (stem cell) injection
• Knee surgery within the last year
• Chronic opioid use
• Chronic pain syndrome/fibromyalgia
• Pain behavior during the clinical encounter as judged by the injecting physician
• Physician specifically ordered injection of corticosteroid/anesthetic or other specific combined corticosteroid injection
• Diagnostic uncertainty by referring provider

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Osteoarthritis

Interventions

Ropivacaine; Saline Solution; Sodium Chloride; Methylprednisolone; Methylprednisolone Acetate

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds; Prednisolone; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Limitations and Caveats

Lack of power due to lower than expected enrollment; follow-up was limited to 3 months.

Results Point of Contact

• Title: Dr. Jacob Sellon
• Organization: Mayo Clinic

sellon.jacob@mayo.edu

507-255-1141

Study Officials

• Jacob L Sellon, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Physical Medicine and Rehabilitation

Study Record Dates

• First Submitted: October 13, 2015
• First Posted: October 15, 2015
• Study Start: October 1, 2015
• Primary Completion: July 1, 2016
• Study Completion: October 1, 2016
• Last Updated: August 21, 2017
• Results First Posted: July 21, 2017

Record last verified: 2017-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)