Collagen: Patients will be treated with a single injection of collagen (2 ml) in the knee joint affected by osteoarthritis
Placebo (saline solution): Patients will be treated with a single injections of saline solution (2 ml) in the knee joint affected by osteoarthritis
Study 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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
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
Primary outcome measure(s)
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"
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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