Actively Recruiting

Phase Not Applicable
Age: 18Years - 75Years
All Genders
NCT04998188

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

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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Trial Site Locations

Total: 1 location

1

Istituto Ortopedico Rizzoli

Bologna, Italy, 40136

Actively Recruiting

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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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