Effectiveness of Five Intraarticular Strategies on Knee Osteoarthritis

NCT03783455 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2018-12-21

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Maimónides Biomedical Research Institute of Córdoba

    lead OTHER

Principal Investigators

  • Lourdes Ladehesa, MD · Hospital Universitario Reina Sofía

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-09-01
Primary Completion
2016-06-01
Completion
2016-06-01

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03783455 on ClinicalTrials.gov