Comparing collagen injection to placebo for knee osteoarthritis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to evaluate the effectiveness of a single intra-articular injection of hydrolyzed collagen compared to a placebo (saline solution) in patients with knee osteoarthritis. A total of 204 participants will be randomly assigned to receive either the collagen injection or the placebo, with follow-up assessments conducted at 1, 3, and 6 months post-injection. Clinical evaluations will include both subjective questionnaires and objective measures such as thermographic assessments to monitor inflammation. After 6 months, participants in the placebo group will have the option to switch to the collagen treatment for an additional 6 months of follow-up.

Why it matters

Who can join: the full rules

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

Where it's running

• Istituto Ortopedico Rizzoli
  Bologna, Italy Recruiting

Study contacts

• Principal investigator: Alessandro Di Martino, MD — Istituto Ortopedico Rizzoli
• Study coordinator: Roberta Licciardi, Msc
• Email: roberta.licciardi@ior.it
• Phone: 0516366567

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.