Hydrolyzed Collagen Formulation vs Placebo in Knee Osteoarthritis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Collagen, Placebo (saline solution).
- Who it may be relevant to
- Registry conditions: Knee Osteoarthritis. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Hydrolyzed Collagen Formulation Versus Placebo in the Treatment of Degenerative Knee Cartilage Injuries
Overview
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.
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
Primary outcome measures
- KOOS-Pain Score [Time frame: 6 months follow-up]
Secondary outcome measures (12)
- IKDC-Subjective Score [Time frame: baseline, 1 month, 3 months, 6 months follow-up]
- KOOS Score [Time frame: baseline, 1 month, 3 months, 6 months follow-up]
- WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) score [Time frame: baseline, 1 month, 3 months, 6 and 12 months follow-up]
- VAS-pain (Visual Analogue Scale) [Time frame: baseline, 1 month, 3 months, 6 months follow-up]
- EQ-VAS [Time frame: baseline, 1 month, 3 months, 6 months follow-up]
- EQ-5D (EuroQoL) Current Health Assessment [Time frame: baseline, 1 month, 3 months, 6 months follow-up]
- TegnerActivity Level Scale [Time frame: baseline, 1 month, 3 months, 6 months follow-up]
- Patient Acceptable Symptom State (PASS) [Time frame: baseline, 1 month, 3 months, 6 months follow-up]
- Objective parameters -Range of motion [Time frame: baseline, 1 month, 3 months, 6 months follow-up]
- Final treatment opinion [Time frame: 6 months follow-up]
- Ultrasound assessment [Time frame: Baseline]
- Thermographic evaluation of the inflammatory status of the knee joint [Time frame: baseline, 1 month, 3 months, 6 months follow-up]
Eligibility criteria
Inclusion criteria
- 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;
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Crossover
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Italy · 1 center
- Istituto Ortopedico Rizzoli — Bologna
Publications
- 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
- 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
- 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
- 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
- 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
- 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
Identifiers
NCT: NCT04998188 · COLL-OA