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

Primary Purpose

Knee Osteoarthritis

Status
Completed
Phase
Phase 4
Locations
Puerto Rico
Study Type
Interventional
Intervention
Depomedrol
Lidocaine
Sponsored by
University of Puerto Rico
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Knee Osteoarthritis focused on measuring knee, arthritis, injections, corticosteroids

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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).

Sites / Locations

  • University of Puerto Rico School Of Medicine Outpatient Clinics

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Suprapatellar Knee Injection Site

Anterolateral knee injection

Arm Description

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

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

Outcomes

Primary Outcome Measures

Short Term Pain improvement
Medium Term Pain Improvement
Self Reported Patient Scores Improvement
WOMAC and Visual Analog Scale will be used to monitor improvement

Secondary Outcome Measures

Pain on injection site
Will compare pain on site of injection on study arms.

Full Information

First Posted
June 25, 2014
Last Updated
May 30, 2017
Sponsor
University of Puerto Rico
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1. Study Identification

Unique Protocol Identification Number
NCT02176304
Brief Title
Does Injection Site Matter? A Randomized Controlled Trial to Evaluate Efficacy of Knee Intraarticular Injections on Improval of Patient Reported Outcomes.
Official Title
Does Injection Site Matter? A Randomized Controlled Trial to Evaluate Efficacy of Knee Intraarticular Injections on Improval of Patient Reported Outcomes.
Study Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
June 2014 (Actual)
Primary Completion Date
September 2014 (Actual)
Study Completion Date
December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Puerto Rico

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis
Keywords
knee, arthritis, injections, corticosteroids

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Suprapatellar Knee Injection Site
Arm Type
Active Comparator
Arm Description
Patients will be injected specified dose of lidocaine and depomedrol through suprapatellar-lateral knee entry site.
Arm Title
Anterolateral knee injection
Arm Type
Active Comparator
Arm Description
Patients will be injected specified dose of lidocaine and depomedrol through anterolateral knee entry site.
Intervention Type
Drug
Intervention Name(s)
Depomedrol
Other Intervention Name(s)
Depomedrol 40 mg/ml
Intervention Description
Depomedrol 40 mg/ml, 1 ml injected to knee on day one of intervention.
Intervention Type
Drug
Intervention Name(s)
Lidocaine
Other Intervention Name(s)
Lidocaine 2%
Intervention Description
Lidocaine 2% soln, 4 ml injected to knee on day 1 of intervention
Primary Outcome Measure Information:
Title
Short Term Pain improvement
Time Frame
1 week
Title
Medium Term Pain Improvement
Time Frame
1 month
Title
Self Reported Patient Scores Improvement
Description
WOMAC and Visual Analog Scale will be used to monitor improvement
Time Frame
1 month
Secondary Outcome Measure Information:
Title
Pain on injection site
Description
Will compare pain on site of injection on study arms.
Time Frame
baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ariel D Davila-Parrilla, MD
Organizational Affiliation
University of Puerto Rico Orthopedics Department
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Antonio Otero-Lopez, MD
Organizational Affiliation
University of Puerto Rico Orthopedics Department
Official's Role
Study Director
Facility Information:
Facility Name
University of Puerto Rico School Of Medicine Outpatient Clinics
City
San Juan
ZIP/Postal Code
00918
Country
Puerto Rico

12. IPD Sharing Statement

Learn more about this trial

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

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