Osteoarthritis Knees Both
Conditions
Keywords
Osteoarthritis, Knees, HA, Micro-fragmented autologous adipose tissue, Hyaluronic acid, Intra-articular injection, Randomized double-blind study
Brief summary
The HYALOFAT study is a randomized controlled double-blind trial with parallel treatment arms and 1:1 allocation. By means of a double-blind randomized controlled trial in patients with symptomatic bilateral OA of the knees, the clinical outcomes of autologous microfragmented adipose tissue injection associated with hyaluronic acid in one knee vs autologous microfragmented adipose tissue injection in the contralateral knee will be evaluated and compared. Each patient will then serve as his or her own control and not be informed of the knee assigned to the treatment group. In addition, it will be the aim of the study to evaluate the safety of the combined treatment by documenting any adverse events.
Detailed description
100 patients with symptomatic bilateral knee OA will be included in a randomized controlled double-blind study in which the clinical outcomes of treating OA with microfragmented autologous adipose tissue associated with high-molecular-weight hyaluronic acid versus treatment with microfragmented autologous adipose tissue will be evaluated and compared. One knee will be treated with an injection of high-molecular-weight hyaluronic acid (4 cc) and microfragmented autologous adipose tissue (6 cc), harvested from the abdominal site. The contralateral knee will be treated with microfragmented autologous adipose tissue (6 cc), also harvested from the abdominal site by liposuction and microfragmentation, combining an injection of 4 cc of saline (NaCl 0.9%) to make the volume of product injected into both knees equal. During screening, the eligibility of potentially enrollable subjects will be assessed.Once they are deemed eligible, the baseline visit will be performed, which will take place in the divisional or research clinic. This will include: - the presentation of the study, the collection of informed consents and the administration and collection of subjective and objective evaluation questionnaires by medical staff. Patients will be clinically evaluated at 0-2-6-12 and 24 months follow-up
Interventions
DEVICEMFAT + HA left knee - MFAT + placebo right knee
The left knee will be treated with an injection of high-molecular-weight hyaluronic acid (4 cc) and microfragmented autologous adipose tissue (6 cc), harvested from the abdominal site.The right knee will be treated with microfragmented autologous adipose tissue (6 cc), also harvested from the abdominal site by liposuction and microfragmentation, combined with an injection of 4 cc of saline (NaCl 0.9%)
BIOLOGICALMFAT + HA right knee - MFAT + placebo left knee
The right knee will be treated with an injection of high-molecular-weight hyaluronic acid (4 cc) and microfragmented autologous adipose tissue (6 cc), harvested from the abdominal site.The left knee will be treated with microfragmented autologous adipose tissue (6 cc), also harvested from the abdominal site by liposuction and microfragmentation, combined with an injection of 4 cc of saline (NaCl 0.9%)
Sponsors
Istituto Ortopedico Rizzoli
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
The patient will not be aware of the side where hyaluronic acid will also be injected in addition to the microfragmented adipose tissue Clinical evaluations will be performed by medical personnel other than those who have performed the surgical and infiltrative procedures
Intervention model description
This is a randomized controlled double-blind parallel-arm study with 1:1 allocation
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Male or female patients aged between 18 and 75; 2. Radiographic evidence of bilateral OA of the knees graded between 2 and 4 on the Kellgren-Lawrence scale; 3. Pain equal to or greater than 4 on the Numeric Rating Scale (NRS) for both knees; 4. Failure, defined as persistence of symptoms after at least 6 months of conservative treatment (pharmacological, physiotherapy, or infiltration treatment); 5. Ability and willingness to undergo the study procedures and comply with the instructions given by the study team; 6. No history of 4\. Failure, defined as persistent symptoms, after at least 6 months of conservative treatment (pharmacological, physiotherapy, or infiltration treatment); 5. Ability and consent of patients to actively participate in the rehabilitation and follow-up protocol; 6. Signature of informed consent
Exclusion criteria
1. Patients incapable of understanding and willing; 2. Diagnosis of active neoplasia; 3. Diagnosis of rheumatoid arthritis, Reiter's syndrome, psoriatic arthritis, gout, ankylosing spondylitis, or arthritis resulting from another inflammatory disease; human immunodeficiency virus (HIV) infection, active viral hepatitis; chondrocalcinosis; 4. Patients with uncontrolled diabetes mellitus; 5. Patients with uncontrolled thyroid metabolic disorders; 6. Patients who abuse alcohol, drugs, or medications; 7. Patients with lower limb misalignment greater than 5°; 8. Body Mass Index \> 35 kg/m2; 9. Pregnancy or breastfeeding, or plans to become pregnant during the study period . 10. Patients with a history of trauma or intra-articular infiltration of therapeutic substances in the 6 months prior to screening. 11. Patients who have undergone knee surgery in the 12 months prior to screening. 12. Patients with insufficient abdominal adipose tissue, as assessed by the investigator.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) | 12 months | It's a standardized and widely used questionnaire to assess the condition of patients with osteoarthritis of the knee and includes assessment of pain, stiffness, and physical function of the joints. It can be administered to the patient. It measures 5 items for pain (range 0-20), two for stiffness (range 0-8), and 17 for functional limitation (range 0-68) that mainly relate to activities of daily living (e.g., getting up from a sitting position, bending over, going up and down stairs etc.); The score is then normalized on a 0-100 scale. Higher values indicate a worse outcome |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| IKDC-Subjective Score | baseline, 2,6,12,24 months | This is a subjective, knee-specific rating scale that is considered one of the most reliable assessment tools in the evaluation of knee pathologies. All questions examines 3 categories: symptoms, sports activity, and knee function. |
| IKDC-Objective Score (Objective International Knee Documentation Committee) | baseline, 2,6,12,24 months | The objective assessment scale has seven parameters related to knee function. The presence of effusion and degree of knee movement are assessed, with the worst value of one of these parameters determining the final IKDC grade. There are four grades (A, B, C, D) which identify a knee assessed as normal, near normal, abnormal, and severely abnormal, respectively. |
| Patient Acceptable Symptom State (PASS) | baseline, 2,6,12,24 months | A tool to assess patient satisfaction in consideration of their current degree of pain, function, and daily activity. Patients can express if their state of health will be satisfying, answering yes or no. |
| EuroQol Visual Analogue Scale (EQ-VAS) | baseline, 2,6,12,24 months | EQ-VAS is a visual analog scale that has a range of scores from 0 (worst imaginable health condition) to 100 (best imaginable health condition). |
| Functional Numerical Rating Scale (NRS -functional) | baseline, 2,6,12,24 months | It is a one-dimensional quantitative numerical scale for assessing functional impairment on a scale of 11 points; the scale requires the patient to select the number that best describes their state of functional disability, from 0 to 10. The higher the value indicated, the higher the degree of disability. |
| Numerical Rating Scale (NRS - pain) | baseline, 2,6,12,24 months | It is a one-dimensional quantitative 11-point pain assessment scale; the scale requires the patient to select the number that best describes the intensity of their pain, from 0 to 10, at that precise moment: 0 means no pain and 10 indicates the worst possible pain. |
| Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) | baseline, 2,6,24 months | It's a standardized and widely used questionnaire to assess the condition of patients with osteoarthritis of the knee and includes assessment of pain, stiffness, and physical function of the joints. It can be administered to the patient. It measures 5 items for pain (range 0-20), two for stiffness (range 0-8), and 17 for functional limitation (range 0-68) that mainly relate to activities of daily living (e.g., getting up from a sitting position, bending over, going up and down stairs etc.); The score is then normalized on a 0-100 scale. Higher values indicate a worse outcome |
| Objective parameters - Circumferences | baseline, 2,6,12,24 months | Bilateral trans- and supra- patellar circumferences measurement for comparative analysis |
| Patient expectations regarding treatment | baseline | The patient must indicate at baseline what clinical benefits they expect from the treatment according to the question: What benefits do you expect to obtain from the treatment you will undergo? The patient can choose from one of the following options: complete recovery, much better, very much better, a little better, or no change. |
| Opinion on the treatment | 6,12,24 months | The patient must indicate their level of satisfaction with the treatment received. The patient can choose from one of the following options: much better, a little better, no change, a little worse, and much worse. |
| Effectiveness of the blinding procedure | baseline | The patient is asked the following question: In which knee do you think the treatment (autologous adipose tissue + hyaluronic acid) was performed? |
| Safety of the procedure | baseline, 2,6,12,24 months | The characteristics and incidence of any adverse events will be documented. |
| Medical history | baseline | Recording of data relating to the duration and onset of symptoms, previous operations,level of activity, and cause of injury |
| Objective parameters- Range of Motion | baseline, 2,6,12,24 months | Evaluation of the Range of Motion for comparative analysis. |
Countries
Italy
Contacts
Primary ContactAlessandro Di Martino, MD
Backup ContactRoberta Licciardi, MsC
Outcome results
None listed