Hydrolyzed Collagen Formulation vs Placebo in Knee Osteoarthritis
NCT04998188 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 204
Last updated 2026-02-03
Summary
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
Interventions
- PROCEDURE
-
Collagen
Patients will be treated with a single injection of collagen (2 ml) in the knee joint affected by osteoarthritis
- PROCEDURE
-
Placebo (saline solution)
Patients will be treated with a single injections of saline solution (2 ml) in the knee joint affected by osteoarthritis
Sponsors & Collaborators
-
Istituto Ortopedico Rizzoli
lead OTHER
Principal Investigators
-
Alessandro Di Martino, MD · Istituto Ortopedico Rizzoli
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- CROSSOVER
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-02-16
- Primary Completion
- 2027-12-31
- Completion
- 2027-12-31
Countries
- Italy
Study Locations
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