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

NCT ID: NCT02176304

Last Updated: 2017-06-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-06-30
• Study Completion Date: 2014-12-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Suprapatellar Knee Injection Site

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

Group Type: ACTIVE_COMPARATOR

Depomedrol

Intervention Type: DRUG

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

Lidocaine

Intervention Type: DRUG

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

Anterolateral knee injection

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

Group Type: ACTIVE_COMPARATOR

Depomedrol

Intervention Type: DRUG

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

Lidocaine

Intervention Type: DRUG

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

Interventions

Depomedrol

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

Intervention Type: DRUG

Lidocaine

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

Intervention Type: DRUG

Other Intervention Names

Depomedrol 40 mg/ml; Lidocaine 2%

Eligibility Criteria

Inclusion 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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Puerto Rico

OTHER

Sponsor Role: lead

Responsible Party

Ariel D. Davila Parrilla, MD

Orthopedic Surgeon

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ariel D Davila-Parrilla, MD

Role: PRINCIPAL_INVESTIGATOR

University of Puerto Rico Orthopedics Department

Antonio Otero-Lopez, MD

Role: STUDY_DIRECTOR

University of Puerto Rico Orthopedics Department

Locations

University of Puerto Rico School Of Medicine Outpatient Clinics

San Juan, , Puerto Rico

Countries

Puerto Rico

Other Identifiers

Knee Injections

Identifier Type: -

Identifier Source: org_study_id