Study of sodium hyaluronate injections for trapeziometacarpal osteoarthritis

Completed

• Conditions: Trapeziometacrpal osteoarthritis; Musculoskeletal Diseases; Arthrosis, unspecified

• Registration Number: ISRCTN83189455
• Lead Sponsor: Hospital Accredited Private Villa Regina [L' Ospedale Privato Accreditato Villa Regina] (Italy)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-02-22
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 58

Inclusion Criteria

1. Patients treated with Hyalgan® in the period within January 2000 and December 2002
2. Patients presenting symptomatic trapeziometacarpal osteoarthritis stated by Kellgren and Lawrence grade scale
3. Patients with at least 6 months of follow-up
4. Patients aged within 50 and 80 years

Exclusion Criteria

1. Arthritic or metabolic pathologies and/or serious trauma
2. Less than 6 months of follow-up
3. Clinically relevant differences in the treatment within enrolled patients

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
At baseline and at each subsequent observation times at 1, 3 and 6 months after the treatment, the efficacy and safety parameters were assessed by the investigator and by patients. The following variables were considered and recorded during the visits:<br>1. Anamnestic and demographic data (only at baseline)<br>2. Spontaneous pain on movement<br>3. Provoked pain on movement <br>4. Pain during night and day<br>5. Morning stiffness <br>6. Physician?s global assessment<br>7. Patient?s global assessment<br>8. Palmar and radial abduction<br>9. Pinch strength<br>10. Nonsteroidal Antiinflammatory Drugs (NSAIDs) intake<br>11. Tolerability of the product

Secondary Outcome Measures

Name	Time	Method
ocal or systemic safety profile of Hyalgan®