Knee Osteoarthritis
Conditions
Keywords
knee, knee osteoarthritis, collagen, collagen injection, osteoarthritis, placebo, Randomized controlled trial, double-blinded
Brief summary
The aim of the study is to compare the 6 months clinical outcome of the treatment with a single intra-articular collagen injection versus a single placebo (saline solution) infiltration in the infiltrative treatment of knee osteoarthritis. The evaluation will be performed through clinical, subjective and objective assessments.
Detailed description
204 patients affected by knee osteoarthritis will be included in a double-blinded randomized controlled trial. Patients in the experimental group will be treated with a single intra-articular injection of collagen (solution of low molecular weight peptides derived from hydrolyzed collagen) instead patients in the control arm, will be treated with a single intra-articular injection of placebo (saline solution). All patients will be evaluated by clinical examination before the infiltrative procedure and they will follow-up at 1,3,6 months. During the follow-up visits ,will be evaluated the inflammatory status of the knee by thermographic assessment and questionnaires, filled out by patients, will be utilized for clinical evaluations. After 6 months, patients in the control arm (saline solution injection), have the possibility to cross-over into the treatment arm (collagen) in which case they will be followed for an additional 6 months.
Interventions
PROCEDURECollagen
Patients will be treated with a single injection of collagen (2 ml) in the knee joint affected by osteoarthritis
PROCEDUREPlacebo (saline solution)
Patients will be treated with a single injections of saline solution (2 ml) in the knee joint affected by osteoarthritis
Sponsors
Istituto Ortopedico Rizzoli
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
his is a double-blind randomized controlled trial with 1:1 allocation. Patients, healthcare professionals who assess clinical and functional outcomes (outcome assessors) and professionals who analyze the data will be "blinded."
Intervention model description
The study is a double-blinded RCT with possibility ,after 6 months, to cross-over from control arm (saline solution ) to the treatment arm (collagen). After 6 months, patients in the control arm have the possibility to cross-over into the treatment arm, in which case they will be followed for an additional 6 months
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Unilateral involvement; 2. Signs and symptoms of degenerative pathology of knee cartilage; 3. Radiographic and MRI signs of degenerative pathology of the knee cartilage (Kellgren-Lawrence 1-4 grades); 4. Failure, defined as the persistence of symptoms, after at least one course of conservative treatment (pharmacological, physiotherapeutic or infiltrative treatment); 5. Ability and consent of patients to actively participate in clinical follow-up;
Exclusion criteria
1. Patients who have undergone intra-articular injections of another substance in the previous 6 months; 2. Patients undergoing knee surgery within the previous 12 months; 3. Patients with malignant neoplasms; 4. Patients with rheumatic diseases; 5. Patients with diabetes; 6. Patients with hematologic diseases (coagulopathies); 7. Patients on anticoagulant therapy; 8. Patients with metabolic disorders of the thyroid gland; 9. Patients abusing alcoholic beverages, drugs or medications; 10. Body Mass Index \> 35; 11. Pregnant or lactating women. 12. Patients with established hypersensitivity to bovine collagen or vitamin C. 13. Patients with joint or peri-articular infections, emarto, erythema, or psoriatic patches in the knee joint area
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| KOOS-Pain Score | 6 months follow-up | KOOS-Pain Score is referred to a subscale of pain composed by 9 items. The score range considerate is 0-100.The score uses a 5-point Likert scale and each question is assigned a score from 0 to 4, where 0 indicates "no pain" and 4 "severe level of pain" |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| IKDC-Subjective Score | baseline, 1 month, 3 months, 6 months follow-up | 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 |
| KOOS Score | baseline, 1 month, 3 months, 6 months follow-up | KOOS SCORE consists of 5 subscales and covers: pain (9 items), symptoms (7 items, two of which are related to stiffness), functions and activities of daily living (17 items), physical function, sports and leisure activities (5 items) and quality of life in relation to the knee (4 items). Each question is scored from 0 to 4, where 0 indicates "no difficulty" and 4 "severe difficulty. Score range 0-100 for each subscale |
| WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) score | baseline, 1 month, 3 months, 6 and 12 months follow-up | It's a standardized questionnaire to assess the condition of patients affected by knee osteoarthritis and includes assessment of pain, stiffness and physical functioning of the joints. It measures 5 items for pain (range 0-20), two for stiffness (range 0-8) and 17 for functional limitation (range 0-68) that relate mainly to activities of daily living. The score is normalized on a 0-100 scale. Higher values indicate a worse outcome. |
| VAS-pain (Visual Analogue Scale) | baseline, 1 month, 3 months, 6 months follow-up | VAS is a visual analogue scale consisting of a range scale (10 cm length), the ends of which correspond to "no pain" and "the strongest pain imaginable". |
| EQ-VAS | baseline, 1 month, 3 months, 6 months follow-up | 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). |
| EQ-5D (EuroQoL) Current Health Assessment | baseline, 1 month, 3 months, 6 months follow-up | The EQ-5D profile, asks patients to classify their health based on self-assessed levels of problems ("no", "some", "extreme") on five dimensions. |
| TegnerActivity Level Scale | baseline, 1 month, 3 months, 6 months follow-up | Tegner activity level scale allows to know the level of physical activity carried out by the patients. Tegner's activity scale classifies the activity according to work and sports activities on a scale from 0 to 10. Zero represents disability because of knee problems and 10 represents soccer a national or international level |
| Patient Acceptable Symptom State (PASS) | baseline, 1 month, 3 months, 6 months follow-up | 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". |
| Objective parameters -Range of motion | baseline, 1 month, 3 months, 6 months follow-up | Evaluation of the Range of Motion for comparative analysis. |
| Final treatment opinion | 6 months follow-up | The patient should indicate satisfaction and relative degree with treatment at the end of the clinical trial (24 months follow-up). All patients will be able to indicate their health condition by choosing from this answers; "Full recovery", "much better", "somewhat better", "no change", "a little worse", "much worse". |
| Ultrasound assessment | Baseline | This examination is useful to do an initial assessment of possible meniscal extrusion in the interested knee joint. |
| Thermographic evaluation of the inflammatory status of the knee joint | baseline, 1 month, 3 months, 6 months follow-up | The evaluation will be performed through the use of a thermal imaging camera. The thermal camera will allow to detect even small variation of knee temperature thus comparing and recording any thermographic changes in the inflammatory state of the joint before and after treatment. |
| Objective parameters - Circumferences | baseline, 1 month, 3 months, 6 months follow-up | Bilateral trans- and supra- patellar circumferences measurement for comparative analysis |
Countries
Italy
Contacts
CONTACTRoberta Licciardi, Msc
CONTACTAlessandro Di Martino, MD
PRINCIPAL_INVESTIGATORAlessandro Di Martino, MD
Istituto Ortopedico Rizzoli
Outcome results
None listed