Hydrolyzed Collagen Formulation vs Placebo in Knee Osteoarthritis

Istituto Ortopedico Rizzoli204 enrolled

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

204

Conditions

Knee Osteoarthritis

Interventions

CollagenPROCEDURE

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

Placebo (saline solution)PROCEDURE

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (1)

Istituto Ortopedico Rizzoli

Bologna, Italy

RECRUITING

Outcomes

Primary Outcomes

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"

Time frame: 6 months follow-up

Secondary Outcomes

IKDC-Subjective Score

This is a subjective, knee-specific rating scale that is considered one of the most reliable assessment tools in the evaluation of knee pathologies. All questions examines 3 categories: symptoms, sports activity, and knee function

Time frame: baseline, 1 month, 3 months, 6 months follow-up

KOOS Score

KOOS SCORE consists of 5 subscales and covers: pain (9 items), symptoms (7 items, two of which are related to stiffness), functions and activities of daily living (17 items), physical function, sports and leisure activities (5 items) and quality of life in relation to the knee (4 items). Each question is scored from 0 to 4, where 0 indicates "no difficulty" and 4 "severe difficulty. Score range 0-100 for each subscale

Time frame: baseline, 1 month, 3 months, 6 months follow-up

WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) score

It's a standardized questionnaire to assess the condition of patients affected by knee osteoarthritis and includes assessment of pain, stiffness and physical functioning of the joints. It measures 5 items for pain (range 0-20), two for stiffness (range 0-8) and 17 for functional limitation (range 0-68) that relate mainly to activities of daily living. The score is normalized on a 0-100 scale. Higher values indicate a worse outcome.

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

VAS-pain (Visual Analogue Scale)

VAS is a visual analogue scale consisting of a range scale (10 cm length), the ends of which correspond to "no pain" and "the strongest pain imaginable".

Central Contacts

Roberta Licciardi, Msc

CONTACT

0516366567 roberta.licciardi@ior.it

Alessandro Di Martino, MD

CONTACT

alessandro.dimartino@ior.it

Data from ClinicalTrials.gov

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