Does Injection Site Matter? A Randomized Controlled Trial to Evaluate

Status Completed

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02176304
Study type	Interventional
Source	University of Puerto Rico
Contact
Status	Completed
Phase	Phase 4
Start date	June 2014
Completion date	December 2014

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms