Hydrolyzed Collagen Formulation vs Placebo in Knee Osteoarthritis
Key facts
- Who runs it
- Istituto Ortopedico Rizzoli
- Where
- Bologna, ItalySee the site
- Trial code
- Status
- Recruiting
- People taking part
- 204 people, planned
- Started
- 16 Feb 2022
- Expected to end
- Dec 2027
- Type of study
- Interventional, 2 groupsOne group gets a placebo (a dummy treatment), for comparison.
- Treatments tested
- Collagen
- Placebo (saline solution)
- Record updated
- 3 February 2026
Who can take part
- Age
- 18 years to 75 years
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 18 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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 on anticoagulant therapy
- Patients abusing alcoholic beverages, drugs or medications
- Patients with malignant neoplasms
- Patients with rheumatic diseases
- Patients with diabetes
- Patients with hematologic diseases (coagulopathies)
- Patients with metabolic disorders of the thyroid gland
- 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
- Body Mass Index > 35
- Pregnant or lactating women
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 75 years old?
Where in Italy
- Istituto Ortopedico RizzoliBologna, ItalyContact: Alessandro Di Martino, MDTaking people
About the trial
What the trial wants to find out
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.
The 2 groups in the trial
- Collagen InjectionTreatment being tested
This group of patients will be treated with single intra-articular injection of collagen.
Treatment: Collagen
- Placebo (saline solution)Placebo, for comparison
This group of patients will be treated with single intra-articular injection of saline solution (placebo). At the 6-month follow-up visit, patients will be informed about the treatment received. Patients of this group can cross-over to the treatment arm after 6 months.
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Hydrolyzed Collagen Formulation Versus Placebo in the Treatment of Degenerative Knee Cartilage Injuries
- Fit questions
- Built from NCT04998188, who can take part
- Record updated
- 3 February 2026