Corticosteroid vs Platelet-Rich Plasma Intra-articular Injections in the Treatment of Knee Osteoarthritis.

NCT06032039 | Unknown Early Phase 1 DMC

• 1 other identifier: CREC-MN.023, 2022/2023
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

Brief Summary

This study will explore the effectiveness of intra-articular knee injections in patients with osteoarthritis by comparing Corticosteroid (triamcinolone) vs Platelet Rich Plasma (PRP). This study is a randomized controlled trial with a sample size of one hundred and sixty patients (160). Patients would be recruited via new referrals and follow-up appointments in the Orthopaedic clinic at the UHWI (University Hospital of the West Indies) with knee osteoarthritis. The aim of the study is to:

1. 1.To determine if platelet-rich plasma injections are better at improving functional outcomes in the knee using Western Ontario and McMaster Universities Arthritis Index (WOMAC) when compared to intraarticular steroids.
2. 2.To identify adverse reactions related to these injections

Conditions

Knee Osteoarthritis

Keywords

Osteoarthritis; Knee; Corticosteroid; Platelet Rich Plasma

Outcome Measures

Primary Outcomes (2)

• Pain of the Knee

  For pain we are primarily using the visual Analogue scale, which is a subjective pain rating numerical scale where the patients rate their pain on a scale of 0-10. The Visual Analogue Scale is a scale from 0-10, where 0 = No Pain and 10 = Worst Pain Possible. The scale also uses faces to indicate the level of pain.

  1 year of follow up visits, post injection. Follow up will be done at 2 weeks, 3 months, 6 months, and 1 year.

• Function of the knee

  For Function we are primarily using the Western Ontario and McMaster Universities Arthritis index (WOMAC), which is a commonly used tool to assess pain and function in patients with arthritis. This is a self administered questionnaire with 24 items in 3 subscales (1) 5 points evaluate pain (2) 2 points stiffness (3) 17 points function a numerical score is calculated and used for comparison. The WOMAC index uses a scale of 0-4 to rate pain, stiffness and difficulty when doing certain activities, where 0 = None and 4 = Extreme.

  1 year of follow up visits, post injection. Follow up will be done at 2 weeks, 3 months, 6 months, and 1 year.

Study Arms (2)

Corticosteroid Injection

ACTIVE COMPARATOR

This arm will receive a corticosteroid (Triamcinalone) injection.

Drug: Triamcinolone

Platelet Rich Plasma Injection (PRP)

ACTIVE COMPARATOR

This arm will receive a PRP injection.

Other: Platelet Rich Plasma

Interventions

Triamcinolone DRUG

Standard treatment for osteoarthritis knee pain

Also known as: Corticosteroid

Corticosteroid Injection

Platelet Rich Plasma OTHER

Alternative treatment for osteoarthritis knee pain

Also known as: PRP

Platelet Rich Plasma Injection (PRP)

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Kellgren and Lawrence grades 2-3 Age 50 years and older

You may not qualify if:

• Patients with secondary OA:
• History of Fractures around the knee joint i. patella ii. tibia plateau iii. intra articular distal femur
• Bleeding diathesis
• History of septic arthritis
• Patients on oral steroid medications
• Patients who received intraarticular steroid injection \< 6 months before enrollment
• Sickle Cell Disease
• Rheumatoid arthritis
• Patients with a diagnosis of knee OA with little or no pain
• Patient with a diagnosis of knee OA being successfully managed with oral medications and physiotherapy
• Knee pain not attributed to a diagnosis of OA
• All patients who refuse to participate

Sponsors & Collaborators

• The University of The West Indies: lead

Study Sites (1)

University Hospital of the West Indies

Kingston, Jamaica

RECRUITING

Related Publications (11)

• Forogh B, Mianehsaz E, Shoaee S, Ahadi T, Raissi GR, Sajadi S. Effect of single injection of platelet-rich plasma in comparison with corticosteroid on knee osteoarthritis: a double-blind randomized clinical trial. J Sports Med Phys Fitness. 2016 Jul-Aug;56(7-8):901-8. Epub 2015 Jul 14.

  PMID: 26173792 BACKGROUND

• Hirsch G, Kitas G, Klocke R. Intra-articular corticosteroid injection in osteoarthritis of the knee and hip: factors predicting pain relief--a systematic review. Semin Arthritis Rheum. 2013 Apr;42(5):451-73. doi: 10.1016/j.semarthrit.2012.08.005. Epub 2013 Jan 29.

  PMID: 23374502 BACKGROUND

• Migliorini F, Driessen A, Quack V, Sippel N, Cooper B, Mansy YE, Tingart M, Eschweiler J. Comparison between intra-articular infiltrations of placebo, steroids, hyaluronic and PRP for knee osteoarthritis: a Bayesian network meta-analysis. Arch Orthop Trauma Surg. 2021 Sep;141(9):1473-1490. doi: 10.1007/s00402-020-03551-y. Epub 2020 Jul 28.

  PMID: 32725315 BACKGROUND

• Richards MM, Maxwell JS, Weng L, Angelos MG, Golzarian J. Intra-articular treatment of knee osteoarthritis: from anti-inflammatories to products of regenerative medicine. Phys Sportsmed. 2016;44(2):101-8. doi: 10.1080/00913847.2016.1168272. Epub 2016 Apr 4.

  PMID: 26985986 BACKGROUND

• Rayegani SM, Raeissadat SA, Taheri MS, Babaee M, Bahrami MH, Eliaspour D, Ghorbani E. Does intra articular platelet rich plasma injection improve function, pain and quality of life in patients with osteoarthritis of the knee? A randomized clinical trial. Orthop Rev (Pavia). 2014 Sep 18;6(3):5405. doi: 10.4081/or.2014.5405. eCollection 2014 Aug 8.

  PMID: 25317308 BACKGROUND

• Gormeli G, Gormeli CA, Ataoglu B, Colak C, Aslanturk O, Ertem K. Multiple PRP injections are more effective than single injections and hyaluronic acid in knees with early osteoarthritis: a randomized, double-blind, placebo-controlled trial. Knee Surg Sports Traumatol Arthrosc. 2017 Mar;25(3):958-965. doi: 10.1007/s00167-015-3705-6. Epub 2015 Aug 2.

  PMID: 26233594 BACKGROUND

• Liow Y, Wang W, Loh VW. Outpatient management of knee osteoarthritis. Singapore Med J. 2017 Oct;58(10):580-584. doi: 10.11622/smedj.2017097.

  PMID: 29119193 BACKGROUND

• Paik J, Duggan ST, Keam SJ. Triamcinolone Acetonide Extended-Release: A Review in Osteoarthritis Pain of the Knee. Drugs. 2019 Mar;79(4):455-462. doi: 10.1007/s40265-019-01083-3.

  PMID: 30847805 BACKGROUND

• Filardo G, Previtali D, Napoli F, Candrian C, Zaffagnini S, Grassi A. PRP Injections for the Treatment of Knee Osteoarthritis: A Meta-Analysis of Randomized Controlled Trials. Cartilage. 2021 Dec;13(1_suppl):364S-375S. doi: 10.1177/1947603520931170. Epub 2020 Jun 19.

  PMID: 32551947 BACKGROUND

• Green SB. How Many Subjects Does It Take To Do A Regression Analysis. Multivariate Behav Res. 1991 Jul 1;26(3):499-510. doi: 10.1207/s15327906mbr2603_7.

  PMID: 26776715 BACKGROUND

• Dhurat R, Sukesh M. Principles and Methods of Preparation of Platelet-Rich Plasma: A Review and Author's Perspective. J Cutan Aesthet Surg. 2014 Oct-Dec;7(4):189-97. doi: 10.4103/0974-2077.150734.

  PMID: 25722595 BACKGROUND

MeSH Terms

Conditions

Osteoarthritis, Knee; Osteoarthritis

Interventions

Triamcinolone; Adrenal Cortex Hormones

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• Wayne Palmer

  Doctor

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Principal Investigator

CONTACT

(876) 371-7045; wayne.palmer02@uwimona.edu.jm

Researcher

CONTACT

(876) 774-4606; raheem.nelson02@mymonauwi.edu.jm

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 19, 2023
• First Posted: September 11, 2023
• Study Start: October 1, 2023
• Primary Completion: October 31, 2024
• Study Completion: April 30, 2025
• Last Updated: May 29, 2024

Record last verified: 2023-07

Locations

JA (1)