Hydrolyzed Collagen Formulation vs Placebo in Knee Osteoarthritis
Recruiting · NCT04998188 · Interventional (participants receive a specific treatment) · Lead sponsor: Istituto Ortopedico Rizzoli
View the official record on ClinicalTrials.gov →Interventions studied
CollagenPlacebo (saline solution)
What this trial is about
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.
Who can take part
Age range
18 Years to 75 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- Unilateral involvement;
- Signs and symptoms of degenerative pathology of knee cartilage;
- Radiographic and MRI signs of degenerative pathology of the knee cartilage (Kellgren-Lawrence 1-4 grades);
- Failure, defined as the persistence of symptoms, after at least one course of conservative treatment (pharmacological, physiotherapeutic or infiltrative treatment);
- Ability and consent of patients to actively participate in clinical follow-up;
Exclusion criteria
- Patients who have undergone intra-articular injections of another substance in the previous 6 months;
- Patients undergoing knee surgery within the previous 12 months;
- Patients with malignant neoplasms;
- Patients with rheumatic diseases;
- Patients with diabetes;
- Patients with hematologic diseases (coagulopathies);
- Patients on anticoagulant therapy;
- Patients with metabolic disorders of the thyroid gland;
- Patients abusing alcoholic beverages, drugs or medications;
- Body Mass Index \> 35;
- Pregnant or lactating women.
- Patients with established hypersensitivity to bovine collagen or vitamin C.
- Patients with joint or peri-articular infections, emarto, erythema, or psoriatic patches in the knee joint area
Where it is running
1 location listed.
- Istituto Ortopedico Rizzoli - Bologna, Italy