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Compares treatment options for Knee Osteoarthritis
Official title Hydrolyzed Collagen Formulation vs Placebo in Knee Osteoarthritis
ClinicalTrials.gov ID: NCT04998188
What this study is testing
- What it's testing
- 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.
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- 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...
- Ability and consent of patients to actively participate in clinical follow-up;
You likely can't join if
- 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);
See the full eligibility 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;
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Bologna, Italy
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bologna, Italy. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.