Hydrolyzed Collagen Formulation vs Placebo in Knee Osteoarthritis

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Процедура Collagen
  Patients will be treated with a single injection of collagen (2 ml) in the knee joint affected by osteoarthritis
• Процедура Placebo (saline solution)
  Patients will be treated with a single injections of saline solution (2 ml) in the knee joint affected by osteoarthritis

Первичные конечные точки

• KOOS-Pain Score [Срок оценки: 6 months follow-up]

Вторичные конечные точки (12)

• IKDC-Subjective Score [Срок оценки: baseline, 1 month, 3 months, 6 months follow-up]
• KOOS Score [Срок оценки: baseline, 1 month, 3 months, 6 months follow-up]
• WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) score [Срок оценки: baseline, 1 month, 3 months, 6 and 12 months follow-up]
• VAS-pain (Visual Analogue Scale) [Срок оценки: baseline, 1 month, 3 months, 6 months follow-up]
• EQ-VAS [Срок оценки: baseline, 1 month, 3 months, 6 months follow-up]
• EQ-5D (EuroQoL) Current Health Assessment [Срок оценки: baseline, 1 month, 3 months, 6 months follow-up]
• TegnerActivity Level Scale [Срок оценки: baseline, 1 month, 3 months, 6 months follow-up]
• Patient Acceptable Symptom State (PASS) [Срок оценки: baseline, 1 month, 3 months, 6 months follow-up]
• Objective parameters -Range of motion [Срок оценки: baseline, 1 month, 3 months, 6 months follow-up]
• Final treatment opinion [Срок оценки: 6 months follow-up]
• Ultrasound assessment [Срок оценки: Baseline]
• Thermographic evaluation of the inflammatory status of the knee joint [Срок оценки: baseline, 1 month, 3 months, 6 months follow-up]

Критерии участия

Критерии включения

• 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;

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Перекрёстный дизайн

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Италия · 1 центр

• Istituto Ortopedico Rizzoli — Bologna

Публикации

• 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

Идентификаторы

NCT: NCT04998188 · COLL-OA

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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