Hydrolyzed Collagen Formulation vs Placebo in Knee Osteoarthritis

NCT04998188 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 204

Last updated 2026-02-03

No results posted yet for this study

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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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04998188 on ClinicalTrials.gov