Hydrolyzed Collagen Formulation vs Placebo in Knee Osteoarthritis
Recruiting now · Not applicable · Has a placebo group
Conditions studied: Knee Osteoarthritis
In brief
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.
Key facts
- Study ID
- NCT04998188
- Run by
- Istituto Ortopedico Rizzoli
- People needed
- 204
- Starts
- 2022-02-16
- Expected to finish
- 2027-12-01
- Last updated by the study team
- 2026-02-03
Who can join
Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
You may qualify 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 infiltrative treatment);
- Ability and consent of patients to actively participate in clinical follow-up;
You may not qualify 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);
- 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
- Istituto Ortopedico Rizzoli — Bologna, Italy (enrolling)
Full record on ClinicalTrials.gov
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