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

May 30, 2017 updated by: Ariel D. Davila Parrilla, MD, University of Puerto Rico

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Puerto Rico
      • San Juan, Puerto Rico, 00918
        • University of Puerto Rico School Of Medicine Outpatient Clinics

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Inclusion criteria include Early osteoarthritis as per Brandt grades, persistent joint pain warranting a clinic visit, no previous injections given, significant pain in visual analog scale, failure of exercise and oral analgesics.

Exclusion Criteria:

  • Exclusion criteria include advanced knee osteoarthritis, patients with bloody effusions, the use of warfarin or antiplatelet therapy, presence of any infection, patients with arthritis other than primary osteoarthritis, patients younger than age 25 due to low likelihood of primary arthritis, pregnant females, diabetics with poor glucose control, and patients that have previously been injected in knee(s).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Suprapatellar Knee Injection Site
Patients will be injected specified dose of lidocaine and depomedrol through suprapatellar-lateral knee entry site.
Drug: Depomedrol
Depomedrol 40 mg/ml, 1 ml injected to knee on day one of intervention.
Other Names:
  • Depomedrol 40 mg/ml
Drug: Lidocaine
Lidocaine 2% soln, 4 ml injected to knee on day 1 of intervention
Other Names:
  • Lidocaine 2%
Active Comparator: Anterolateral knee injection
Patients will be injected specified dose of lidocaine and depomedrol through anterolateral knee entry site.
Drug: Depomedrol
Depomedrol 40 mg/ml, 1 ml injected to knee on day one of intervention.
Other Names:
  • Depomedrol 40 mg/ml
Drug: Lidocaine
Lidocaine 2% soln, 4 ml injected to knee on day 1 of intervention
Other Names:
  • Lidocaine 2%

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Short Term Pain improvement
Time Frame: 1 week
1 week
Medium Term Pain Improvement
Time Frame: 1 month
1 month
Self Reported Patient Scores Improvement
Time Frame: 1 month
WOMAC and Visual Analog Scale will be used to monitor improvement
1 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain on injection site
Time Frame: baseline
Will compare pain on site of injection on study arms.
baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Puerto Rico

Investigators

  • Principal Investigator: Ariel D Davila-Parrilla, MD, University of Puerto Rico Orthopedics Department
  • Study Director: Antonio Otero-Lopez, MD, University of Puerto Rico Orthopedics Department

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2014

Primary Completion (Actual)

September 1, 2014

Study Completion (Actual)

December 1, 2014

Study Registration Dates

First Submitted

June 25, 2014

First Submitted That Met QC Criteria

June 26, 2014

First Posted (Estimate)

June 27, 2014

Study Record Updates

Last Update Posted (Actual)

June 1, 2017

Last Update Submitted That Met QC Criteria

May 30, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Knee Injections

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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