NCT04998188

Hydrolyzed Collagen Formulation vs Placebo in Knee Osteoarthritis

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 204 (estimated)
• Sponsor: Istituto Ortopedico Rizzoli · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed description

204 patients affected by knee osteoarthritis will be included in a double-blinded randomized controlled trial. Patients in the experimental group will be treated with a single intra-articular injection of collagen (solution of low molecular weight peptides derived from hydrolyzed collagen) instead patients in the control arm, will be treated with a single intra-articular injection of placebo (saline solution). All patients will be evaluated by clinical examination before the infiltrative procedure and they will follow-up at 1,3,6 months. During the follow-up visits ,will be evaluated the inflammatory status of the knee by thermographic assessment and questionnaires, filled out by patients, will be utilized for clinical evaluations. After 6 months, patients in the control arm (saline solution injection), have the possibility to cross-over into the treatment arm (collagen) in which case they will be followed for an additional 6 months.

Conditions

• Knee Osteoarthritis

Interventions

Type	Name	Description
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

Timeline

• Start date: 2022-02-16
• Primary completion: 2027-12-01
• Completion: 2027-12-01
• First posted: 2021-08-10
• Last updated: 2026-02-03

Locations

1 site across 1 country: Italy