Hydrolyzed Collagen Formulation vs Placebo in Knee Osteoarthritis

NCT04998188 | Recruiting

• 1 other identifier: COLL-OA
• Study Type: interventional
• Target: 204
• Locations: 1 country
• Sites: 1

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.

Conditions

Knee Osteoarthritis

Keywords

knee; knee osteoarthritis; collagen; collagen injection; osteoarthritis; placebo; Randomized controlled trial; double-blinded

Outcome Measures

Primary Outcomes (1)

• KOOS-Pain Score

  KOOS-Pain Score is referred to a subscale of pain composed by 9 items. The score range considerate is 0-100.The score uses a 5-point Likert scale and each question is assigned a score from 0 to 4, where 0 indicates "no pain" and 4 "severe level of pain"

  6 months follow-up

Secondary Outcomes (13)

• IKDC-Subjective Score

  baseline, 1 month, 3 months, 6 months follow-up

• KOOS Score

  baseline, 1 month, 3 months, 6 months follow-up

• WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) score

  baseline, 1 month, 3 months, 6 and 12 months follow-up

• VAS-pain (Visual Analogue Scale)

  baseline, 1 month, 3 months, 6 months follow-up

• EQ-VAS

  baseline, 1 month, 3 months, 6 months follow-up

Study Arms (2)

Collagen Injection

EXPERIMENTAL

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

Procedure: Collagen

Placebo (saline solution)

PLACEBO COMPARATOR

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.

Procedure: Placebo (saline solution)

Interventions

Collagen PROCEDURE

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

Collagen Injection

Placebo (saline solution) PROCEDURE

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

Placebo (saline solution)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• Patients who have undergone intra-articular injections of another substance in the previous 6 months;
• Patients undergoing knee surgery within the previous 12 months;
• Patients with malignant neoplasms;
• Patients with rheumatic diseases;
• Patients with diabetes;
• Patients with hematologic diseases (coagulopathies);
• Patients on anticoagulant therapy;
• Patients with metabolic disorders of the thyroid gland;
• Patients abusing alcoholic beverages, drugs or medications;
• Body Mass Index \> 35;
• Pregnant or lactating women.
• Patients with established hypersensitivity to bovine collagen or vitamin C.
• Patients with joint or peri-articular infections, emarto, erythema, or psoriatic patches in the knee joint area

Sponsors & Collaborators

• Istituto Ortopedico Rizzoli: lead

Study Sites (1)

Istituto Ortopedico Rizzoli

Bologna, 40136, Italy

RECRUITING

Related Publications (6)

• 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.

  PMID: 27043347 BACKGROUND

• 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.

  PMID: 32447428 BACKGROUND

• 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.

  PMID: 31277508 BACKGROUND

• 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.

  PMID: 31533151 BACKGROUND

• 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.

  PMID: 19453649 BACKGROUND

• 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.

  PMID: 25577327 BACKGROUND

MeSH Terms

Conditions

Osteoarthritis, Knee; Osteoarthritis

Interventions

Collagen; Saline Solution

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Biopolymers; Polymers; Macromolecular Substances; Extracellular Matrix Proteins; Scleroproteins; Proteins; Amino Acids, Peptides, and Proteins; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Alessandro Di Martino, MD

  Istituto Ortopedico Rizzoli

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Roberta Licciardi, Msc

CONTACT

0516366567; roberta.licciardi@ior.it

Alessandro Di Martino, MD

CONTACT

alessandro.dimartino@ior.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: his is a double-blind randomized controlled trial with 1:1 allocation. Patients, healthcare professionals who assess clinical and functional outcomes (outcome assessors) and professionals who analyze the data will be "blinded."
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The study is a double-blinded RCT with possibility ,after 6 months, to cross-over from control arm (saline solution ) to the treatment arm (collagen). After 6 months, patients in the control arm have the possibility to cross-over into the treatment arm, in which case they will be followed for an additional 6 months

Study Record Dates

• First Submitted: May 17, 2021
• First Posted: August 10, 2021
• Study Start: February 16, 2022
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: February 3, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)