NCT03783455

Effectiveness of Five Intraarticular Strategies on Knee Osteoarthritis

Assessment of Short-term Effectiveness of Five Local Treatment Modalities in Patients With Symptomatic Knee Osteoarthritis: a Randomized Prospective Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 150 (actual)
• Sponsor: Maimónides Biomedical Research Institute of Córdoba · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

BACKGROUND: Current medical treatment strategies for knee osteoarthritis (OA) are aimed at pain reduction and symptom control. The Non-Arthroscopic Joint Lavage (NAJL) is included inside the therapeutic algorithm of knee OA when other therapies are contraindicated or have lost effectiveness. The large variety of potentially invasive interventions available (joint lavage included) has raised the need to assess their efficacy. The objective of this study is to compare the short-term effectiveness of five treatment strategies in patients with knee osteoarthritis (OA). METHODS: It was conducted a randomized prospective study involving 150 patients of whom 76.7% were females. The age range was 40-81 years. All patients had knee OA according to the American College of Rheumatology criteria, with Kellgren-Lawrence radiographic grades II and III. Patients were assigned to five groups, 1) non-arthroscopic joint lavage (NAJL) (n= 30), 2) NAJL plus hyaluronic acid (HA) (n= 32), 3) NAJL plus corticosteroid (CS) (n= 32), 4) HA (n= 31), 5) CS (n= 25). Evaluations took place at baseline, one and three months after enrollment. Demographic variables, Western Ontario and McMaster University Osteoarthritis Index (WOMAC) and Lequesne scores were recorded. Statistical analysis included mixed analysis of variance, post-hoc comparisons with Sidak's adjustment, and multiple linear regression using as outcome WOMAC total at 3 months. TRIAL REGISTRATION: The protocol of the study was approved by the "Hospital Universitario Reina Sofía" Ethics Committee, under the number 1996, in the Minutes 208 of 29 May 2012.

Conditions

• Osteo Arthritis Knee

Interventions

Type	Name	Description
PROCEDURE	Non arthroscopic joint lavage	Instillation of 4 litters of cold physiological serum
PROCEDURE	Non arthroscopic joint lavage plus corticosteroid	Instillation of 4 litters of cold physiological serum followed by intraarticular injection of triamcinolone
PROCEDURE	Non arthroscopic joint lavage plus hyaluronic acid	Instillation of 4 litters of cold physiological serum followed by intraarticular injection of hyaluronic acid
PROCEDURE	Intraarticular injection of corticosteroid	Intraarticular injection containing 40 mg of triamcinolone acetonide.
PROCEDURE	Intraarticular injection of hyaluronic acid	Intraarticular injection containing 4 mL of a bioengineered hyaluronic acid.

Timeline

• Start date: 2015-09-01
• Primary completion: 2016-06-01
• Completion: 2016-06-01
• First posted: 2018-12-21
• Last updated: 2018-12-21