Does Injection Site Matter? A Randomized Controlled Trial to Evaluate Efficacy of Knee Intraarticular Injections on Improval of Patient Reported Outcomes.

NCT02176304 | Completed Phase 4

• 1 other identifier: Knee Injections
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Knee osteoarthritis is one of the most prevalent orthopedic conditions worldwide. With the aging population, a 40% patient increase is expected to present at clinics with complaints of primary osteoarthritis by 2025. Multiple studies have attempted to establish non-surgical criteria for knee arthritis and usage of resources to avoid major surgery. It has long been accepted as a treatment option for patients who have failed to respond to NSAIDs and other non-surgical therapies to receive intra-articular injections of steroid and anesthesia mixtures to hold off disease progression. Various studies have compared different sites of injection and the accuracy rate of the injection being within the joint. Recent studies report a 66% accuracy on palpation-guided injection on the anterolateral knee, 93% accuracy on palpation-guided injection on the superolateral portal of the knee, and new studies show an improvement of up to 98% with use of ultrasound guiding software. However, in a health care system with limited resources, providing patients with US-guided injections represented an increased cost of $178.35 per patient as per 2010 Medicare reports. Therefore, assuming these accuracy rates, we will compare the anterolateral and superolateral portals for knee injection and their clinical effect to monitor if in fact there is a difference in patient reported outcomes. As a secondary analysis, if no difference is found, a strong case for palpation-guided injections versus ultrasound-guided injections can be made. In this study we will prospectively enroll 60 patients to be divided into two 30 patient groups with primary knee osteoarthritis. Patients that qualify as subjects will be treated with an intraarticular knee injection through an anterolateral portal or a suprapatellar portal as per group in which they are placed. Scores will be given for pain of the injection and of the baseline illness and compared on a subsequent visit to assess self-reported functional outcomes.

Conditions

Knee Osteoarthritis

Keywords

knee; arthritis; injections; corticosteroids

Outcome Measures

Primary Outcomes (3)

• Short Term Pain improvement

  1 week

• Medium Term Pain Improvement

  1 month

• Self Reported Patient Scores Improvement

  WOMAC and Visual Analog Scale will be used to monitor improvement

  1 month

Secondary Outcomes (1)

• Pain on injection site

  baseline

Study Arms (2)

Suprapatellar Knee Injection Site

ACTIVE COMPARATOR

Patients will be injected specified dose of lidocaine and depomedrol through suprapatellar-lateral knee entry site.

Drug: Depomedrol; Drug: Lidocaine

Anterolateral knee injection

ACTIVE COMPARATOR

Patients will be injected specified dose of lidocaine and depomedrol through anterolateral knee entry site.

Drug: Depomedrol; Drug: Lidocaine

Interventions

Depomedrol DRUG

Depomedrol 40 mg/ml, 1 ml injected to knee on day one of intervention.

Also known as: Depomedrol 40 mg/ml

Anterolateral knee injection; Suprapatellar Knee Injection Site

Lidocaine DRUG

Lidocaine 2% soln, 4 ml injected to knee on day 1 of intervention

Also known as: Lidocaine 2%

Anterolateral knee injection; Suprapatellar Knee Injection Site

Eligibility Criteria

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

Sponsors & Collaborators

• University of Puerto Rico: lead

Study Sites (1)

University of Puerto Rico School Of Medicine Outpatient Clinics

San Juan, 00918, Puerto Rico

Location

MeSH Terms

Conditions

Osteoarthritis, Knee; Arthritis

Interventions

Lidocaine

Condition Hierarchy (Ancestors)

Osteoarthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Ariel D Davila-Parrilla, MD

  University of Puerto Rico Orthopedics Department

  PRINCIPAL INVESTIGATOR

• Antonio Otero-Lopez, MD

  University of Puerto Rico Orthopedics Department

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Orthopedic Surgeon

Study Record Dates

• First Submitted: June 25, 2014
• First Posted: June 27, 2014
• Study Start: June 1, 2014
• Primary Completion: September 1, 2014
• Study Completion: December 1, 2014
• Last Updated: June 1, 2017

Record last verified: 2017-05

Locations

PR (1)