Saline Lavage X Saline Lavage and Osteonil® Mini in Rizarthritis

Summary

Although a common problem, hand osteoarthritis (HOA) is less studied than knee and hip. In the age group of 71-100 years, the prevalence of symptomatic HOA reaches 26% of women and 13% of men. These patients lose hand strength and have difficulty with day-to-day manual activities. The main joints involved are the proximal and distal interphalangeals and the carpometacarpal joint of the thumb. In the educational Project PARQVE, the prevalence of HOA was 23.7% at inclusion in the program, and 47.4% after one year, with loss of grip strength. There is controversy over the effect of viscosupplementation in the treatment of rhizarthritis when considering pain. However, strength is a very important function parameter that must be evaluated for function and quality of life maintenance. Concerned about the importance of maintaining strength and function in our program (PARQVE), we have added specific exercises tom improve hand strength and range of motion. Trying to optimize the treatment and confronting questions about the effect of the joint wash, called placebo in the comparative studies with corticosteroid and/or hyaluronic acid injection, we did a work where all the patients will be washed with physiological saline solution but a group, after emptying, will receive 1mL of hyaluronic acid with mannitol.

PURPOSE: To compare isolated lavage with lavage followed by injection of hyaluronic acid with mannitol into carpometacarpal osteoarthritis joint of the thumb.

METHODS: Forty joints of patients with multiple osteoarthritis (rhizoarthritis, including) and comorbidities (two or more of: overweight or obesity, hyperglycemia, dyslipidemia, hyperuricemia, hypertension) will be allocated into two groups: Lavage (LS) and Lavage and Injection Hilauronic acid (LO). Both groups will undergo joint lavage with saline solution. The LO group will receive the 20 mg / mL hilauronic acid injection with 5mg mannitol. Both groups will be guided in the clinical treatment of osteoarthritis and metabolic syndrome and will be given daily exercises for the hands. They will be evaluated with the quick DASH questionnaire, Sollerman Test and by measuring the palmar, lateral and pulp-pulp grip strength, in addition to measuring the ROM and VAS pain moments immediately prior to the procedure, one, three and six months after the articular procedure.

Conditions

• Rhizarthrosis
• Metabolic Disease

Interventions

BEHAVIORAL

Visual Analog Scale (VAS)

Answer Visual Analog Scale (VAS) questionnaire at baseline, 1 month, 3 months and 6 months

BEHAVIORAL

Range of Motion (ROM)

submitted to ROM at at baseline, 1 month, 3 months and 6 months

BEHAVIORAL

Palmar grip strength

submitted to palmar grip strength at at baseline, 1 month, 3 months and 6 months

BEHAVIORAL

Lateral grip strength

submitted to lateral grip strength at at baseline, 1 month, 3 months and 6 months

BEHAVIORAL

Pulp-pulp pinch strength

submitted to pulp-pulp pinch strength strength at at baseline, 1 month, 3 months and 6 months

DRUG

Lavage with physiologic saline solution

Joint lavage with physiologic saline solution. After emptying of the joint, 1mL saline solution will be injected.

DRUG

Lavage with physiologic saline solution and Osteonil® Mini

Joint lavage with physiologic saline solution and Osteonil® Mini

BEHAVIORAL

Quick Dash

Answer Quick Dash questionnaire at baseline, 1 month, 3 months and 6 months

BEHAVIORAL

Sollerman Test

Perform Sollerman Test at baseline, 1 month, 3 months and 6 months

Sponsors & Collaborators

• University of Sao Paulo General Hospital

  lead OTHER

Principal Investigators

• Marcia U Rezende, MD; PhD · Department of Orthopedics and Traumatology - HCFMUSP

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

CROSSOVER

Eligibility

Min Age

40 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-03-30

Primary Completion

2018-03-30

Completion

2019-08-30

Countries

• Brazil

Study Locations