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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.

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02176304
Enrollment
60
Registered
2014-06-27
Start date
2014-06-30
Completion date
2014-12-31
Last updated
2017-06-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Knee Osteoarthritis

Keywords

knee, arthritis, injections, corticosteroids

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.

Interventions

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

DRUGLidocaine

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

Sponsors

University of Puerto Rico
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

*

Design outcomes

Primary

MeasureTime frameDescription
Short Term Pain improvement1 week
Medium Term Pain Improvement1 month
Self Reported Patient Scores Improvement1 monthWOMAC and Visual Analog Scale will be used to monitor improvement

Secondary

MeasureTime frameDescription
Pain on injection sitebaselineWill compare pain on site of injection on study arms.

Countries

Puerto Rico

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026