Corticosteroid Injection for Knee Arthritis

(COSTI Trial)

Overseen by Amir Khoshbin, MD, FRCS (C)

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Recruiting

Sponsor: Unity Health Toronto

Disqualifiers: Inflammatory arthritis, Cognitive impairment, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

Through a triple-blinded randomized control trial, the primary purpose of this pilot study is to assess the efficacy of administering peri-operative contralateral corticosteroid injection in patients undergoing TKA. The secondary outcome was to assess the effect of contralateral corticosteroid injection on pain and functional outcomes of patients undergoing TKA.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the drug corticosteroid injection for knee arthritis?

Corticosteroid injections have been used since the 1950s to quickly relieve symptoms of knee arthritis, especially during severe flare-ups, by reducing inflammation and pain. However, the benefits are often short-lived, and there is some concern about potential harm to the joint over time. ^{1 2 3 4 5}

Is it safe to use corticosteroid injections for knee arthritis?

Corticosteroid injections for knee arthritis are generally considered safe, but they can have side effects like skin reactions, infections, and tendon issues. They may also increase the risk of needing knee surgery and can affect blood sugar levels, especially in people with diabetes. ^{1 4 6 7 8}

How is the drug Contralateral Corticosteroid Injection different from other treatments for knee arthritis?

Contralateral Corticosteroid Injection involves injecting corticosteroids into the knee joint to reduce inflammation and pain, which is a common approach for managing knee arthritis. This treatment is unique because it focuses on the use of corticosteroids, which are often debated in terms of their effectiveness, dosage, and frequency compared to other options like hyaluronic acid injections or surgical interventions. ^{1 4 5 9 10}

Research Team

Amir Khoshbin, MD, FRCS (C)

Principal Investigator

Unity Health Toronto

Eligibility Criteria

This trial is for individuals with knee osteoarthritis who are scheduled for total knee replacement surgery. Participants should not have any known allergies to corticosteroids or bupivacaine, and must be willing to undergo the study procedures.

Inclusion Criteria

I am 18 years old or older.

I haven't had injections in the opposite knee within the last year.

I have pain in the opposite knee with a score over 4 out of 10.

Exclusion Criteria

Cognitive impairment (dementia, Alzheimer's, uncontrolled delirium) which will prevent patients from completing primary outcome measure or comply with follow-up requirements

I have had knee surgery, such as a total knee replacement or fracture repair.

I have had knee surgery before.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either a contralateral corticosteroid injection or a sham band-aid application during the peri-operative period for TKA

Peri-operative

1 visit (in-person)

Follow-up

Participants are monitored for pain, function, and quality of life using various outcome measures

1 year

4 visits (in-person) at 4, 8, 12 weeks and 1 year post-surgery

Treatment Details

Interventions

• Contralateral Corticosteroid Injection (Corticosteroid)

Trial Overview The study tests if a corticosteroid injection in the opposite knee can help reduce pain and improve function after knee replacement surgery. It's a triple-blinded trial, meaning neither patients, doctors nor assessors know who receives the real treatment.

Participant Groups

Group I: Group A - Corticosteroid Injection Experimental Treatment 1 Intervention

Corticosteroid injection - 80mg methylprednisolone (total volume 2ml) with 6 mL of 1% Bupivacaine without epinephrine (Total Volume 8 mL). The patient will be brought to the regional room where a fully licensed anaesthesiologist will perform standard of care anaesthesia followed by an ultrasound guided intra-articular knee injection with steroid AFTER the spinal neuraxial blockage has already been administered.

Group II: Group B - Band-Aid Placement Placebo Group 1 Intervention

The patient will be brought to the regional room where a fellowship trained interventional pain/regional anaesthesiologist will perform standard of care anaesthesia followed by the application of a band-aid.

Who Is Running the Clinical Trial?

Unity Health Toronto

Lead Sponsor

Trials

572

Recruited

470,000+

Findings from Research

In a study of 3,822 patients with or at risk of knee osteoarthritis, those who received corticosteroid injections had a significantly higher risk of needing knee arthroplasty, with 31.3% undergoing surgery compared to only 5.0% of those who did not receive injections.

Each corticosteroid injection increased the absolute risk of knee arthroplasty by 9.4% over nine years, suggesting that these injections may harm the joint and accelerate the progression of osteoarthritis, leading to a recommendation for more conservative treatment approaches.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intra-articular corticosteroid injections increase the risk of requiring knee arthroplasty. Wijn, SRW., Rovers, MM., van Tienen, TG., et al.[2020]

Local corticosteroid injections are generally safe and can effectively manage symptoms in conditions like rheumatoid arthritis and knee osteoarthritis, providing relief for up to three months in some cases.

While these injections can help with acute flare-ups and certain symptoms, they do not significantly prevent joint damage or erosive changes, and their use should complement other treatments like physical therapy and disease-modifying drugs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intra-articular corticosteroids. An updated assessment. Gray, RG., Gottlieb, NL.[2006]

In a study involving 60 patients undergoing bilateral total knee arthroplasty, the use of a multimodal cocktail injection with corticosteroids did not show significant differences in pain relief, motion range, or swelling compared to injections without corticosteroids.

The findings suggest that multimodal periarticular injections without corticosteroids can effectively manage postoperative pain and swelling, indicating that corticosteroids like betamethasone may not be necessary for optimal outcomes in this context.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Local Efficacy of Corticosteroids as an Adjuvant for Periarticular Cocktail Injection in Simultaneous Bilateral Total Knee Arthroplasty: A Prospective Randomized Double-Blind Controlled Trial. Peng, H., Wang, W., Lin, J., et al.[2021]

Intra-articular injections of ketorolac and corticosteroids both provided significant pain relief and functional improvement in patients with knee osteoarthritis, with no significant differences in outcomes between the two treatments after 3 months.

While corticosteroid injections showed slightly better pain relief in the first week, both treatments resulted in similar success rates, indicating that ketorolac can be a safe alternative to corticosteroids for managing knee OA symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of Intra-articular Ketorolac Versus Corticosteroid Injection for Knee Osteoarthritis: A Retrospective Comparative Study. Xu, J., Qu, Y., Li, H., et al.[2022]

Corticosteroid injections can lead to side effects ranging from mild skin reactions and flare responses to serious complications like infections, tendon ruptures, and osteonecrosis.

Patients with diabetes should be cautious, as corticosteroids can affect blood glucose levels, and there is also a risk of visual side effects related to central serous chorioretinopathy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Complications Associated with Intra-Articular and Extra-Articular Corticosteroid Injections. Honcharuk, E., Monica, J.[2021]

Intra-synovial corticosteroids are a rapid and effective treatment for juvenile chronic arthritis (JCA), particularly beneficial for limited joint involvement while waiting for disease-modifying drugs to take effect.

While generally safe, there are important contraindications and potential complications, such as infection and joint damage, emphasizing the need for proper injection technique and post-injection care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intra-synovial corticosteroid injections in juvenile chronic arthritis--a review. See, Y.[2020]

Intraarticular corticosteroid injections are a common treatment for knee pain due to osteoarthritis, positioned between conservative treatments like ice therapy and more invasive options like knee replacement surgery.

The paper discusses various types of corticosteroids and their combinations with local anesthetics, highlighting the flexibility in treatment approaches for managing knee osteoarthritis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Current concepts on the use of corticosteroid injections for knee osteoarthritis. Law, TY., Nguyen, C., Frank, RM., et al.[2022]

Corticosteroid knee injections provide short-term symptomatic relief for knee osteoarthritis, but their effectiveness is limited to this short duration, with no long-term benefits supported by evidence.

The accuracy of these injections can be problematic, with up to 20% of procedures failing to place the steroid correctly in the joint, and the risk of serious infectious complications can be as high as 1 in 3,000, especially in high-risk patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The efficacy, accuracy and complications of corticosteroid injections of the knee joint. McGarry, JG., Daruwalla, ZJ.[2021]

References

1. England pubmed.ncbi.nlm.nih.gov

Intra-articular corticosteroid injections increase the risk of requiring knee arthroplasty. [2020]

2. United States pubmed.ncbi.nlm.nih.gov

Injectable corticosteroids in treatment of arthritis of the knee. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Intra-articular corticosteroids. An updated assessment. [2006]

4. United States pubmed.ncbi.nlm.nih.gov

Local Efficacy of Corticosteroids as an Adjuvant for Periarticular Cocktail Injection in Simultaneous Bilateral Total Knee Arthroplasty: A Prospective Randomized Double-Blind Controlled Trial. [2021]

5. India pubmed.ncbi.nlm.nih.gov

Corticosteroid injection into the osteoarthritic knee: drug selection, dose, and injection frequency. [2012]

6. United States pubmed.ncbi.nlm.nih.gov

Effect of Intra-articular Ketorolac Versus Corticosteroid Injection for Knee Osteoarthritis: A Retrospective Comparative Study. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Complications Associated with Intra-Articular and Extra-Articular Corticosteroid Injections. [2021]

8. Singapore pubmed.ncbi.nlm.nih.gov

Intra-synovial corticosteroid injections in juvenile chronic arthritis--a review. [2020]

9. England pubmed.ncbi.nlm.nih.gov

Current concepts on the use of corticosteroid injections for knee osteoarthritis. [2022]

10. Germany pubmed.ncbi.nlm.nih.gov

The efficacy, accuracy and complications of corticosteroid injections of the knee joint. [2021]