Condition category
Musculoskeletal Diseases
Date applied
23/01/2012
Date assigned
22/02/2012
Last edited
14/08/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Hand osteoarthritis (OA) is a common disease, and the trapeziometacarpal joint (TMCJ) is commonly targeted by OA. With respect to the long-term results, Hyaluronic Acid (HA) seems to be the better alternative in the treatment of TMCJ OA, even with a single injection. HA injections were found to be effective in reducing pain and improving fine hand function. The aim of this study was to evaluate the effectiveness of injections of HA for the treatment of pain and disability due to TMCJ OA.

Who can participate?
Patients aged 50 to 80 with symptomatic TMCJ OA treated with Hyaluronic Acid between January 2000 and December 2002.

What does the study involve?
All patients received an injection of Hyaluronic Acid once weekly for three consecutive weeks. Examinations were carried out 1, 3 and 6 months after the first treatment.

What are the possible benefits and risks of participating?
All participants will receive a treatment that may improve pain, radial and palmar abduction, pinch strength, duration of morning stiffness and swelling. There are no known serious risks to participants.

Where is the study run from?
This study has been conducted in the private hospitals Villa Regina, at the rheumatology services , and conducted by Prof. Frizziero as principal investigator.

When is the study starting and how long is it expected to run for?
It is a retrospective study collecting data of patients treated in the period within January 2000 and December 2002.

Who is funding the study?
Hospital Accredited Private Villa Regina [L' Ospedale Privato Accreditato Villa Regina] (Italy).

Who is the main contact?
Dr Nicola Giordan
ngiordan@fidiapharma.it

Trial website

Contact information

Type

Scientific

Primary contact

Prof Luigi Frizziero

ORCID ID

Contact details

Via Rubiani
2
Bologna
40124
Italy
luigi.frizziero@libero.it

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

Q03-08-01

Study information

Scientific title

A retrospective study of intra-articular sodium hyaluronate (MW 500-730 KDa) injections for trapeziometacarpal osteoarthritis

Acronym

Study hypothesis

The purpose of this retrospective open-label study was to evaluate the efficacy and tolerability of intra-articular injections of HA for the treatment of pain and disability due to trapeziometacarpal joint osteoarthritis.

Ethics approval

Local Health Authority of Bologna Ethics Committee for Medical Research, 05/05/2009

Study design

Retrospective open-label study

Primary study design

Interventional

Secondary study design

Non randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Trapeziometacrpal osteoarthritis

Intervention

All patients underwent one cycle of three weekly intra-articular (i.a.) injections of 0.8 mL (10 mg/mL) of Hyalgan® (hyaluronan) (MW 500– 730 KDa) using a dorsolateral approach after palpating the joint space. Joints were injected with a 22-gauge needle after preparation with 10% povidone iodine and ethyl chloride local spray.

Five visits were scheduled:
Visit one: enrolment and start of therapy
Visit two: during study treatment
Visit three: during study treatment
Visit four: during study treatment (1 months after baseline)
Visit five: during study treatment (3 months after baseline)
Visit six: patient final evaluation (6 months after baseline)

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

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:
1. Anamnestic and demographic data (only at baseline)
2. Spontaneous pain on movement
3. Provoked pain on movement
4. Pain during night and day
5. Morning stiffness
6. Physician’s global assessment
7. Patient’s global assessment
8. Palmar and radial abduction
9. Pinch strength
10. Nonsteroidal Antiinflammatory Drugs (NSAIDs) intake
11. Tolerability of the product

Secondary outcome measures

Local or systemic safety profile of Hyalgan®

Overall trial start date

01/01/2000

Overall trial end date

31/12/2002

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

58

Participant 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

Recruitment start date

01/01/2000

Recruitment end date

31/12/2002

Locations

Countries of recruitment

Italy

Trial participating centre

Via Rubiani, 2
Bologna
40124
Italy

Sponsor information

Organisation

Hospital Accredited Private Villa Regina [L' Ospedale Privato Accreditato Villa Regina] (Italy)

Sponsor details

Rheumatology Services
Via Castiglione 115
Bologna
40100
Italy

Sponsor type

Hospital/treatment centre

Website

http://www.villaregina-bo.it/

Funders

Funder type

Hospital/treatment centre

Funder name

Hospital Accredited Private Villa Regina [L' Ospedale Privato Accreditato Villa Regina] (Italy)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes