Actively Recruiting
Hydrolyzed Collagen Formulation vs Placebo in Knee Osteoarthritis
Led by Istituto Ortopedico Rizzoli · Updated on 2026-02-03
204
Participants Needed
1
Research Sites
302 weeks
Total Duration
On this page
AI-Summary
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.
CONDITIONS
Official Title
Hydrolyzed Collagen Formulation vs Placebo in Knee Osteoarthritis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Unilateral knee involvement
- Signs and symptoms of degenerative knee cartilage disease
- Radiographic and MRI evidence of degenerative knee cartilage disease (Kellgren-Lawrence grades 1-4)
- Persistent symptoms after at least one course of conservative treatment (medication, physical therapy, or injections)
- Ability and willingness to actively participate in clinical follow-up
You will not qualify if you...
- Intra-articular injections of other substances within the past 6 months
- Knee surgery within the past 12 months
- Presence of malignant tumors
- Rheumatic diseases
- Diabetes
- Blood disorders such as coagulopathies
- Use of anticoagulant medications
- Thyroid metabolic disorders
- Abuse of alcohol, drugs, or medications
- Body Mass Index greater than 35
- Pregnant or lactating women
- Known allergy to bovine collagen or vitamin C
- Joint or surrounding infections, swelling, redness, or psoriatic patches in the knee area
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Istituto Ortopedico Rizzoli
Bologna, Italy, 40136
Actively Recruiting
Research Team
R
Roberta Licciardi, Msc
CONTACT
A
Alessandro Di Martino, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
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