Hydrolyzed Collagen Formulation vs Placebo in Knee Osteoarthritis

NCT ID: NCT04998188

Last Updated: 2025-12-10

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 204 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-02-16
• Study Completion Date: 2025-12-31

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Collagen Injection

This group of patients will be treated with single intra-articular injection of collagen.

Group Type: EXPERIMENTAL

Collagen

Intervention Type: PROCEDURE

Patients will be treated with a single injection of collagen (2 ml) in the knee joint affected by osteoarthritis

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.

Group Type: PLACEBO_COMPARATOR

Placebo (saline solution)

Intervention Type: PROCEDURE

Patients will be treated with a single injections of saline solution (2 ml) in the knee joint affected by osteoarthritis

Interventions

Collagen

Patients will be treated with a single injection of collagen (2 ml) in the knee joint affected by osteoarthritis

Intervention Type: PROCEDURE

Placebo (saline solution)

Patients will be treated with a single injections of saline solution (2 ml) in the knee joint affected by osteoarthritis

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

1. Unilateral involvement;

2. Signs and symptoms of degenerative pathology of knee cartilage;

3. Radiographic and MRI signs of degenerative pathology of the knee cartilage (Kellgren-Lawrence 1-4 grades);

4. Failure, defined as the persistence of symptoms, after at least one course of conservative treatment (pharmacological, physiotherapeutic or infiltrative treatment);

5. Ability and consent of patients to actively participate in clinical follow-up;

Exclusion Criteria

1. Patients who have undergone intra-articular injections of another substance in the previous 6 months;

2. Patients undergoing knee surgery within the previous 12 months;

3. Patients with malignant neoplasms;

4. Patients with rheumatic diseases;

5. Patients with diabetes;

6. Patients with hematologic diseases (coagulopathies);

7. Patients on anticoagulant therapy;

8. Patients with metabolic disorders of the thyroid gland;

9. Patients abusing alcoholic beverages, drugs or medications;

10. Body Mass Index > 35;

11. Pregnant or lactating women.

12. Patients with established hypersensitivity to bovine collagen or vitamin C.

13. Patients with joint or peri-articular infections, emarto, erythema, or psoriatic patches in the knee joint area

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Istituto Ortopedico Rizzoli

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Alessandro Di Martino, MD

Role: PRINCIPAL_INVESTIGATOR

Istituto Ortopedico Rizzoli

Locations

Istituto Ortopedico Rizzoli

Bologna, , Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Roberta Licciardi, Msc

Role: CONTACT

roberta.licciardi@ior.it

0516366567

Alessandro Di Martino, MD

Role: CONTACT

alessandro.dimartino@ior.it

Facility Contacts

Alessandro Di Martino, MD

Role: primary

alessandro.dimartino@ior.it

6366567 ext. 051

Roberta Licciardi, MSc

Role: backup

roberta.licciardi@ior.it

6366567 ext. 051

References

Filardo G, Kon E, Longo UG, Madry H, Marchettini P, Marmotti A, Van Assche D, Zanon G, Peretti GM. Non-surgical treatments for the management of early osteoarthritis. Knee Surg Sports Traumatol Arthrosc. 2016 Jun;24(6):1775-85. doi: 10.1007/s00167-016-4089-y. Epub 2016 Apr 4.

Reference Type: BACKGROUND

PMID: 27043347 (View on PubMed)

Volpi P, Zini R, Erschbaumer F, Beggio M, Busilacchi A, Carimati G. Effectiveness of a novel hydrolyzed collagen formulation in treating patients with symptomatic knee osteoarthritis: a multicentric retrospective clinical study. Int Orthop. 2021 Feb;45(2):375-380. doi: 10.1007/s00264-020-04616-8. Epub 2020 May 23.

Reference Type: BACKGROUND

PMID: 32447428 (View on PubMed)

De Luca P, Colombini A, Carimati G, Beggio M, de Girolamo L, Volpi P. Intra-Articular Injection of Hydrolyzed Collagen to Treat Symptoms of Knee Osteoarthritis. A Functional In Vitro Investigation and a Pilot Retrospective Clinical Study. J Clin Med. 2019 Jul 4;8(7):975. doi: 10.3390/jcm8070975.

Reference Type: BACKGROUND

PMID: 31277508 (View on PubMed)

Farr J, Gomoll AH, Yanke AB, Strauss EJ, Mowry KC; ASA Study Group. A Randomized Controlled Single-Blind Study Demonstrating Superiority of Amniotic Suspension Allograft Injection Over Hyaluronic Acid and Saline Control for Modification of Knee Osteoarthritis Symptoms. J Knee Surg. 2019 Nov;32(11):1143-1154. doi: 10.1055/s-0039-1696672. Epub 2019 Sep 18.

Reference Type: BACKGROUND

PMID: 31533151 (View on PubMed)

Furuzawa-Carballeda J, Munoz-Chable OA, Barrios-Payan J, Hernandez-Pando R. Effect of polymerized-type I collagen in knee osteoarthritis. I. In vitro study. Eur J Clin Invest. 2009 Jul;39(7):591-7. doi: 10.1111/j.1365-2362.2009.02154.x.

Reference Type: BACKGROUND

PMID: 19453649 (View on PubMed)

Vucic K, Jelicic Kadic A, Puljak L. Survey of Cochrane protocols found methods for data extraction from figures not mentioned or unclear. J Clin Epidemiol. 2015 Oct;68(10):1161-4. doi: 10.1016/j.jclinepi.2014.11.016. Epub 2014 Dec 18.

Reference Type: BACKGROUND

PMID: 25577327 (View on PubMed)

Other Identifiers

COLL-OA

Identifier Type: -

Identifier Source: org_study_id