Safety and performance of trehalose hyaluronic acid versus standard infiltrative therapy based on medium weight sodium hyaluronate in knee joint osteoarthritis treatment
| ISRCTN | ISRCTN18428696 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN18428696 |
- Submission date
- 09/09/2021
- Registration date
- 30/09/2021
- Last edited
- 09/11/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Plain English summary of protocol
Background and study aims
Knee osteoarthritis is a disease affecting the knee joint that gets worse over time. It can lead to stiffness and swelling of the knee and can cause pain. Hyaluronic acid is used as a treatment for patients with knee osteoarthritis that continues to cause pain after standard treatment. This study intends to study a new version of hyaluronic acid. Trehalose is a chemical used to stabilize the composition of many pills and eye drops. Recently, there have been laboratory studies that show that trehalose helps hyaluronic acid remain stable and is safe and approved by the FDA when used with hyaluronic acid. This means that it, in combination with trehalose, hyaluronic acid does not break down as quickly, so could last for longer in the body, and provide pain relief for a longer period of time.
Who can participate?
Adults aged 21 years old and older with persistent knee pain due to osteoarthritis that has not been reduced with standard therapy (medicine, rehabilitation, and rest) for 6 months.
What does the study involve?
Participants will be allocated to one of two groups, with an equal chance of being in either group (like tossing a coin). Participants and researchers will not have a choice in the treatment given. In one group the patients will be injected in the knee with the standard hyaluronic acid. In the other group, patients will be injected with hyaluronic acid with added trehalose. Participants will not know which treatment they have received during the study and neither will the doctors administering their treatment.
What are the possible benefits and risks of participating?
It is hoped that a benefit of participating will be that patients are able to achieve longer-lasting results of pain relief or pain reduction if combined with trehalose. This product is safe, so no adverse reactions are expected.
Where is the study run from?
OASI Bioresearch Foundation (Italy)
When is the study starting and how long is it expected to run for?
From February 2019 to October 2021
Who is funding the study?
OASI Bioresearch Foundation (Italy)
Who is the main contact?
Macarena Morales
maquismoralis@hotmail.com
Contact information
Scientific
Via Amadeo G.A 24 1-2
Milano
20133
Italy
 ORCID ID |
0000-0003-1483-9870 |
|---|---|
| Phone | +34 (0)673780061 |
| maquismoralis@hotmail.com |
Study information
| Study design | Single-centre prospective double-blinded randomized control trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | GP practice |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Efficacy evaluation of trehalose-hyaluronic acid versus non-trehalose hyaluronic acid in persistent symptomatic knee osteoarthritis patients, with outcome measurement comparison of KOOS, IKDC, and VAS score at basal, 3 and 6 months |
| Study objectives | It is hypothesized that in vivo trehalose-hyaluronic acid (T-HA) has longer-lasting clinical results than non-trehalose hyaluronic acid (NT-HA) when applied as an injectable formula for osteoarthritis (OA) symptomatic knees. |
| Ethics approval(s) | Approved 01/05/2019, OASI Institutional review board (via GA Amadeo Milano 20133 Italy; +39 (0)270124931; info@oasiortopedia.it), ref: not applicable |
| Health condition(s) or problem(s) studied | Osteoarthritis of the knee |
| Intervention | Participants are randomized with an allocation ratio of 1:1 to receive either T-HA or NT-HA. The manufacturer provided the products labelled as A or B (corresponding to group A or B, respectively). Both products had the same syringe, color (transparent), texture, and quantity (2 ml). In this way, the study was blinded for patients, clinicians, researchers, and the manufacturer who handled the product. The nature of the product was revealed only when the study was finished. Each patient received three doses separated within 15 days. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Phase IV |
| Drug / device / biological / vaccine name(s) | Hyaluronic acid |
| Primary outcome measure | Treatment performance measured using the Knee Injury and Osteoarthritis Outcome Score (KOOS), International Knee Documentation Committee (IKDC), and Visual Analogue Scale (VAS) at baseline, 3, and 6 months |
| Secondary outcome measures | Safety measured using adverse reactions recorded for the duration of the trial |
| Overall study start date | 01/02/2019 |
| Completion date | 01/10/2021 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 80 Years |
| Sex | Both |
| Target number of participants | 60 in total, 30 per arm |
| Total final enrolment | 60 |
| Key inclusion criteria | 1. Aged 18 to 80 years 2. Symptomatic knee osteoarthritis, grade I to III according to Kellgren and Lawrence classification 3. Without pain relief after at least 3 months of non-invasive treatment 4. Osteoarthritis diagnosed by x-ray and classified according to Kellgren and Lawrence classification |
| Key exclusion criteria | 1. Any recent intra-articular injection therapy 2. Knee instability 3. Significant axial deviation 4. Systemic disorders such as rheumatoid arthritis, coagulopathies, or infections |
| Date of first enrolment | 01/06/2019 |
| Date of final enrolment | 01/04/2021 |
Locations
Countries of recruitment
- Italy
Study participating centre
Milano
20133
Italy
Sponsor information
Research organisation
Via Amadeo G.A 24 1-2
Milano
20133
Italy
| Phone | +39 (0)270124931 |
|---|---|
| agobbi@oasiortopedia.it | |
| Website | https://www.gobbicartilagedoctor.com/en/about-us/dr-alberto-gobbi/ |
"ROR" |
https://ror.org/048qh2s42 |
Funders
Funder type
Research organisation
No information available
Results and Publications
| Intention to publish date | 10/09/2021 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are/will be available upon request from fellow@oasiortopedia.it. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 01/09/2022 | 09/11/2023 | Yes | No |
Editorial Notes
09/11/2023: Publication reference added.
27/10/2021: The sponsor email has been updated.
28/09/2021: Trial's existence confirmed by INNATE S.r.l.
