Clinical trial on the intra-articular efficacy of MD-Knee (collagen medical device-knee) versus sodium hyaluronate in patients with knee osteoarthritis
| ISRCTN | ISRCTN93862496 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN93862496 |
| Secondary identifying numbers | MDG20121404 |
- Submission date
- 12/01/2016
- Registration date
- 18/01/2016
- Last edited
- 31/03/2016
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Plain English Summary
Background and study aims
Osteoarthritis (OA) is the most common type of arthritis and affects millions of people worldwide. It occurs when the protective cartilage on the end of bones wears away. The bones then rub against one another, causing stiffness, pain and a reduction in the range of movement. OA most often affects the knee joint, and is the leading cause of knee replacement surgery worldwide. In recent years, a number of treatments have been developed, which are injected directly into the affected joint. One such product is sodium hyaluronate (ARTZ®), which contains a form of hyaluronic acid (a chemical naturally found in the joints). By injecting ARTZ® into space where the bones of the joint meet (intra-articular injection) it acts to cushion and protect the joint, helping to reduce pain and improve range of movement. MD-Knee is a new intra-articular injection which has been developed to help treat OA. It contains collagen (a common protein which plays an important role in the structure of skin, bone, tendons and cartilage) derived from pigs. This is designed to work by providing a natural “scaffolding” to support the knee joint. The aim of this study is to find out whether MD-Knee or sodium hyaluronate (ARTZ®) is more effective in the treatment of patients with knee OA.
Who can participate?
Adults over 40 years of age who are suffering from knee OA.
What does the study involve?
Participants are randomly allocated to one of two groups. Participants in the first group are treated using MD-Knee, which is injected into the joint space (intra-articular injection) at a dose of 4ml, once a week for a total of five weeks. Participants in the second group are treated using ARTZ®, which is given by intra-articular injection at a dose of 2.5ml, once a week for a total of five weeks. Participants in both groups complete a number of questionnaires and patient interviews at the start of the study and again three and six months after treatment, in order to measure their pain levels and whether their condition has improved.
What are the possible benefits and risks of participating?
Participants may benefit from an improvement to their condition, experiencing lower levels of pain and a better quality of life. There are no significant risks of taking part in this study as the treatments offered are already used in the treatment of the disease.
Where is the study run from?
U.O.S. San Pietro Fatebenefratelli Hospital Rheumatology (Italy)
When is the study starting and how long is it expected to run for?
April 2013 to May 2015
Who is funding the study?
Guna S.p.a. (Italy)
Who is the main contact?
Dr Vincenzo Miranda
v.miranda@guna.it
Contact information
Scientific
Via Palmanova 71
Milan
20132
Italy
| Phone | +39 02 28018358 |
|---|---|
| v.miranda@guna.it |
Scientific
U.O.S. Reumatologia Ospedale San Pietro Fatebenefratelli
Via Cassia, 600
Rome
00189
Italy
 ORCID ID |
0000-0001-8560-5866 |
|---|
Study information
| Study design | Double-blind randomised active-controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| 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 | A double blind randomized active-controlled clinical trial on the intra-articular use of MD-Knee versus sodium hyaluronate in patients with knee osteoarthritis |
| Study acronym | JOINT |
| Study hypothesis | The aim of this study is to evaluate the use of collagen MD-Knee versus sodium hyaluronate (ARTZ®) in patients with knee OA. |
| Ethics approval(s) | Ordine Ospedaliero di San Giovanni di Dio- Fatebenefratelli- Provincia di Religiosa di San Pietro (Rome), 13/12/2015, ref: 116/2012/C.B |
| Condition | Osteoarthritis (OA) |
| Intervention | Participants are randomly allocated to one of two groups. Group A: Participants are treated using MD-Knee (Guna S.p.a., Milan, Italy), administered via the intra-articular injection of two 2.0 ml ampules, once a week for a period of 5 consecutive weeks. Group B: Participants are treated using ARTZ® (Seikagaku, Tokyo, Japan), administered via the intra-articular injection of one 2.5 ml ampoule of sodium hyaluronate (ARTZ®), once a week for a period of 5 consecutive weeks. All participants are monitored for all parameters considered in the trial (lequesne knee index (LKI), visual analogue scale (VAS), acetaminophen consumption 1000mg, SF36 questionnaire and adverse events) at 1 month and 3 weeks (first follow-up) and 4 months and 3 weeks (second follow-up) after the end of the treatment. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | 1. ARTZ (Sodium Hyaluronate Injection) 2. Collagen MD-Knee |
| Primary outcome measure | Clinical improvement of condition is measured using the lequesne knee index (LKI) score at baseline and 3 months. |
| Secondary outcome measures | 1. Clinical improvement of condition is measured using the lequesne knee index (LKI) score at baseline and 6 months 2. Pain is measured using the visual analogue scale (VAS) at baseline, 3 and 6 months 3. Health status is measured using the Short Form (36) Health Survey (SF36) at baseline, 3 and 6 months 4. Pain Killer consumption is measured using a patient diary completed between baseline to 6 months 5. Rate of adverse events (AE) are determined through observation by the investigators and patient reporting using the electronic- Case Report Form (e-CRF) between baseline to 6 months |
| Overall study start date | 18/04/2013 |
| Overall study end date | 08/05/2015 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 29 patients in Group A (MD-Knee) and 31 patients in Group B (ARTZ®) were enrolled.Women included in Group A were 86.2% and 64.5% in Group B; mean age was similar in both groups (approximately 69 years). |
| Participant inclusion criteria | 1. Ambulatory adult patients affected by knee OA 2. Diagnosis of OA according to the ARA (American Rheumatism Association) criteria 3. Ages 40 years or over 4. Score greater than 7.0 on the Lequesne Knee Index at baseline 5. Persistence of pain in the knee for at least the last three months 6. Radiological degree II-III according to the Kellgren-Lawrence scale 7. Patients able to comply with the study procedures |
| Participant exclusion criteria | 1. Presence of comorbidities (i.e. rheumatoid arthritis, spondyloarthritis, connective tissue disease, polymyalgia rheumatica, gout, Paget's disease, septic arthritis, fractures, osteonecrosis, and fibromyalgia) 2. Patients with skin or subcutaneous tissue infection in the area of the joint to be treated 3. Patients who had used oral, parenteral or intra-articular corticosteroids in the preceding three months 4. Patients taking topical analgesics that may interfere with the evaluation of the study 5. Patients on anticoagulant therapy or suffering from thrombocytopenia and/or coagulopathy 6. Patient with allergy to products of porcine origins |
| Recruitment start date | 02/05/2013 |
| Recruitment end date | 03/04/2014 |
Locations
Countries of recruitment
- Italy
Study participating centre
Roma
00189
Italy
Sponsor information
Industry
Via Palmanova 71
Milan
20132
Italy
| Website | http://guna.com/it/ |
|---|---|
"ROR" |
https://ror.org/04mg7be43 |
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | 30/06/2016 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in BMC Musculoskeletal Disorders journal. |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 22/02/2016 | Yes | No |
Editorial Notes
26/02/2016: Publication reference added.
