Evaluation of quality of life following treatment with Hymovis in patients with knee osteoarthritis and/or meniscal tear
| ISRCTN | ISRCTN39292293 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN39292293 |
| Secondary identifying numbers | BAL-HYA-2018-01 |
- Submission date
- 26/04/2023
- Registration date
- 11/05/2023
- Last edited
- 11/05/2023
- 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 joint disease in the world population. It is characterized by cartilage degeneration and knee pain and dysfunction. A meniscus tear is an injury to a part of the knee called the meniscus. The menisci are two crescent-shaped pads of thick, rubbery shock-absorbing cartilage in the knee joint. They lie between the thigh bone (femur) and the shin bone (tibia). Knee OA and meniscus tears are among the most common knee injuries. There are several oral treatments available with proven effectiveness for this disease. Hyaluronic acid (HA) offers a new alternative treatment. The aim of this study is to evaluate treatment with a special type of HA commercialized under the name Hymovis.
Who can participate?
Patients aged 18 years and over with knee OA or meniscus tear who come for medical examination after an injection of Hymovis
What does the study involve?
Information is collected for 3 months for patients with meniscal tear and 6 months for patients with knee OA. At the inclusion visit (10 days after the last injection of Hymovis) the pain and functionality of the knee that the patients had before undergoing the treatment is evaluated. Follow-up visits are after 1, 2 and 3 months for the meniscal tear group and after 1, 2, 3, and 6 months for the knee OA and mixed group.
What are the possible benefits and risks of participating?
The patients will participate in an innovative study. There are no risks expected.
Where is the study run from?
Centre de Tecnificació Esportiva de la Residencia Blume (Spain)
When is the study starting and how long is it expected to run for?
July 2018 to December 2020
Who is funding the study?
MSK Diagnòstic i Docència SLP (Spain)
Who is the main contact?
Dr Ramón Balius Matas, ramonbaliusmatas@gmail.com
Contact information
Principal Investigator
Centre de Tecnificació Esportiva de la Residencia Blume.
onsell Català de l’Esport
Generalitat de Catalunya
Av. dels Països Catalans, 40-48
Esplugues de Llobregat
Barcelona
08950
Spain
| Phone | +34 (0)628305581 |
|---|---|
| ramonbaliusmatas@gmail.com |
Study information
| Study design | Epidemiological non-intervention study collecting retrospective and prospective, descriptive and multicenter information |
|---|---|
| Primary study design | Observational |
| Secondary study design | Epidemiological study |
| Study setting(s) | Hospital |
| Study type | Quality of life |
| Participant information sheet | Not available in web format, please use the contact details to request a participant information sheet |
| Scientific title | Quality of life, physical activity and satisfaction of patients after intra-articular injection of hyaluronic acid with mobile reticulum for the treatment of chondral injury of the knee due to osteoarthritis due to overuse and/or in the conservative treatment of the meniscus injury |
| Study acronym | HYAQoL |
| Study hypothesis | The main objective of this study is to evaluate the improvement in quality of life, through the assessment, among other things, of the return to physical activity and patient satisfaction after intra-articular injection of hyaluronic acid with mobile reticulum (viscosupplementation) in knee injuries: chondral injury due to overuse osteoarthritis and/or in the conservative treatment of meniscal injury. |
| Ethics approval(s) | Approved 01/10/2018, the ethics committee for clinical research of the Catalan sports council (Consell Catalá de l’Sport, Av. Països Catalans, 40-48, 08950, Esplugues del Llobregat, Barcelona, Spain; +34 (0)609390346; dbrotons@gencat.cat), ref: 16/2018 CEICEGC |
| Condition | Knee osteoarthritis, meniscal tear |
| Intervention | The study recruited patients over 18 years of age, of both sexes, who have undergone intra-articular treatment with mobile reticulum hyaluronic acid for chondral knee injury due to mild to moderate knee osteoarthritis due to overuse syndrome or in conservative treatment of the knee. knee meniscal injury and who go to the doctor for their first follow-up visit after the intra-injections. Information was collected longitudinally for 3 months for patients with meniscal tear and 6 months for patients with knee OA (KOA). At the inclusion visit (10 days after the last injection of Hymovis) the pain and functionality of the knee that the patients had before undergoing the treatment were evaluated using the Visual Analog Scale (VAS), Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) and Knee Injury and Osteoarthritis Outcome Score (KOOS) questionnaires. Follow-up visits were 1, 2 and 3 months for the meniscal tear (MT) group and 1, 2, 3, and 6 months for the KOA and mixed group. Patients completed written questionnaires of VAS, WOMAC and KOOS at all follow-up visits. Written questionaries of QoL and patient satisfaction were given at 3 months follow-up (MT group) and 6 months (KOA and mixed group). During the inclusion and follow-up visits, the researchers collected sociodemographic and objective and subjective clinical data, as well as the use of concomitant medication. The evaluations could be performed within a time window of ±7 days. Participants agreed to interrupt NSAID consumption at least 24 h before each visit for the entire study. |
| Intervention type | Device |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Hymovis |
| Primary outcome measure | 1. Quality of life (QoL) determined using several instruments, including the KOOS score, WOMAC score, Patient's Global Improvement Impression Scale (PGI-I), ad hoc QoL single question 2. Physical activity determined using specific sub-dimensions from KOOS: activities of daily living (ADL), sport and recreation (Sport/Rec) 3. Satisfaction with the HA treatment evaluated using a visual analogue scale of satisfaction and an ad-hoc questionnaire Measured at 1, 2 and 3 months for the MT group and 1, 2, 3 and 6 months for the KOA and mixed group |
| Secondary outcome measures | 1. Pain in the previous 7 days to the visit measured using the VAS score 2. Local tolerability at the site of injection of the viscosupplementation product assessed through retrospective collection considering redness and pain occurring in the minutes following treatment sessions 3. Systemic adverse events recorded during the follow-up visits Measured at 1, 2 and 3 months for the MT group and 1, 2, 3 and 6 months for the KOA and mixed group |
| Overall study start date | 19/07/2018 |
| Overall study end date | 30/12/2020 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 178 |
| Total final enrolment | 165 |
| Participant inclusion criteria | The study population comprised patients (male or female) older than 18 years seen at one of the participating clinics between December 2018 and July 2019 for their first follow-up visit after intra-articular injection of mobile reticulum hyaluronic acid due to: 1. Mild to moderate symptomatic knee osteoarthritis responding to clinical and radiological criteria of American College of Rheumatology (ACR) and a Kallgren and Lawrence (KL) score II/III evidenced by radiography and/or MRI. Patients received two consecutive intra-articular injections of HYMOVIS (3 ml syringe with 8 mg of non-cross-linked HA alkylamida HYADD4; FIDIA Farmaceutici, Italy) given at 1-week intervals according to the prospect. 2. Knee meniscal tear (traumatic or degenerative) objectifiable by radiography and/or MRI. Patients received two consecutive intra-articular injections of HYMOVIS given at 2-week intervals according to the prospect. 3. Mild to moderate symptomatic knee osteoarthritis with meniscal tear. Patients received two consecutive intra-articular injections of HYMOVIS given at 1-week intervals according to the prospect. |
| Participant exclusion criteria | 1. Viscosupplementation or corticosteroid therapy in the last 6 months 2. Concomitant diseases that could interfere with the tests during the data collection period or that could lead to erroneous results (i.e., rheumatoid arthritis, metabolic bone diseases, gout, Paget's disease of bone, symptomatic chondrocalcinosis) 3. Knee arthroplasty or other knee surgery in the last 12 months 4. Any scheduled surgery during the data collection period 5. Evidence or suspicion of infection in the affected joint or skin diseases of the knee, such as dermatitis or psoriasis 6. Patients with bilateral knee OA |
| Recruitment start date | 01/12/2018 |
| Recruitment end date | 30/07/2019 |
Locations
Countries of recruitment
- Spain
Study participating centre
Generalitat de Catalunya.
Av. dels Països Catalans, 40-48
Esplugues de Llobregat
Barcelona
08950
Spain
Sponsor information
Other
Consell Català de l’Esport
Generalitat de Catalunya
Av. dels Països Catalans, 40-48
Esplugues de Llobregat
Barcelona
08950
Spain
| Phone | +34 (0)678624671 |
|---|---|
| ramonbaliusmatas@gmail.com |
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | 31/12/2023 |
|---|---|
| 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 journal |
| IPD sharing plan | The datasets generated during and /or analyzed during the current study are/will be available upon request from Dr Ramon Balius Matas (amonbaliusmatas@gmail.com) |
Editorial Notes
27/04/2023: Trial's existence confirmed by the ethics committee for clinical research of the Catalan sports council.
