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临床试验/NCT02176304
NCT02176304已完成4 期

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

University of Puerto Rico1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2014年6月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
60
试验地点
1
主要终点
Short Term Pain improvement

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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).

研究组 & 干预措施

Suprapatellar Knee Injection Site

Active Comparator

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

干预措施: Depomedrol (Drug)

Suprapatellar Knee Injection Site

Active Comparator

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

干预措施: Lidocaine (Drug)

Anterolateral knee injection

Active Comparator

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

干预措施: Depomedrol (Drug)

Anterolateral knee injection

Active Comparator

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

干预措施: Lidocaine (Drug)

结局指标

主要结局

Short Term Pain improvement

时间窗: 1 week

Medium Term Pain Improvement

时间窗: 1 month

Self Reported Patient Scores Improvement

时间窗: 1 month

WOMAC and Visual Analog Scale will be used to monitor improvement

次要结局

  • Pain on injection site(baseline)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ariel D. Davila Parrilla, MD

Orthopedic Surgeon

University of Puerto Rico

研究点 (1)

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