Hydrolyzed Collagen Formulation Versus Placebo in the Treatment of Degenerative Knee Cartilage Injuries

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• 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;

Locations
Other Locations
Italy
Istituto Ortopedico Rizzoli
RECRUITING
Bologna
Contact Information
Primary
Roberta Licciardi, Msc
roberta.licciardi@ior.it
0516366567
Backup
Alessandro Di Martino, MD
alessandro.dimartino@ior.it
Time Frame
Start Date: 2022-02-16
Estimated Completion Date: 2025-12
Participants
Target number of participants: 204
Treatments
Experimental: Collagen Injection
This group of patients will be treated with single intra-articular injection of collagen.
Placebo_comparator: Placebo (saline solution)
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.
Related Therapeutic Areas
Sponsors
Leads: Istituto Ortopedico Rizzoli

This content was sourced from clinicaltrials.gov