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Hydrolyzed Collagen Formulation vs Placebo in Knee Osteoarthritis

Primary Purpose

Knee Osteoarthritis

Status
Recruiting
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Collagen
Placebo (saline solution)
Sponsored by
Istituto Ortopedico Rizzoli
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Knee Osteoarthritis focused on measuring knee, knee osteoarthritis, collagen, collagen injection, osteoarthritis, placebo, Randomized controlled trial, double-blinded

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Istituto Ortopedico RizzoliRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Collagen Injection

Placebo (saline solution)

Arm Description

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

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.

Outcomes

Primary Outcome Measures

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"

Secondary Outcome Measures

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
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
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.
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".
EQ-VAS
EQ-VAS Is a visual analog scale that has a range of scores from 0 (worst imaginable health condition) to 100 (best imaginable health condition).
EQ-5D (EuroQoL) Current Health Assessment
The EQ-5D profile, asks patients to classify their health based on self-assessed levels of problems ("no", "some", "extreme") on five dimensions.
TegnerActivity Level Scale
Tegner activity level scale allows to know the level of physical activity carried out by the patients. Tegner's activity scale classifies the activity according to work and sports activities on a scale from 0 to 10. Zero represents disability because of knee problems and 10 represents soccer a national or international level
Patient Acceptable Symptom State (PASS)
A tool to assess patient satisfaction in consideration of their current degree of pain, function, and daily activity. Patients can express if their state of health will be satisfying, answering "yes" or "no".
Objective parameters -Range of motion
Evaluation of the Range of Motion for comparative analysis.
Final treatment opinion
The patient should indicate satisfaction and relative degree with treatment at the end of the clinical trial (24 months follow-up). All patients will be able to indicate their health condition by choosing from this answers; "Full recovery", "much better", "somewhat better", "no change", "a little worse", "much worse".
Ultrasound assessment
This examination is useful to do an initial assessment of possible meniscal extrusion in the interested knee joint.
Thermographic evaluation of the inflammatory status of the knee joint
The evaluation will be performed through the use of a thermal imaging camera. The thermal camera will allow to detect even small variation of knee temperature thus comparing and recording any thermographic changes in the inflammatory state of the joint before and after treatment.
Objective parameters - Circumferences
Bilateral trans- and supra- patellar circumferences measurement for comparative analysis

Full Information

First Posted
May 17, 2021
Last Updated
September 27, 2023
Sponsor
Istituto Ortopedico Rizzoli
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1. Study Identification

Unique Protocol Identification Number
NCT04998188
Brief Title
Hydrolyzed Collagen Formulation vs Placebo in Knee Osteoarthritis
Official Title
Hydrolyzed Collagen Formulation Versus Placebo in the Treatment of Degenerative Knee Cartilage Injuries
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 16, 2022 (Actual)
Primary Completion Date
August 1, 2022 (Actual)
Study Completion Date
December 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Istituto Ortopedico Rizzoli

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis
Keywords
knee, knee osteoarthritis, collagen, collagen injection, osteoarthritis, placebo, Randomized controlled trial, double-blinded

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
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
Masking
ParticipantOutcomes Assessor
Masking Description
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."
Allocation
Randomized
Enrollment
204 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Collagen Injection
Arm Type
Experimental
Arm Description
This group of patients will be treated with single intra-articular injection of collagen.
Arm Title
Placebo (saline solution)
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Collagen
Intervention Description
Patients will be treated with a single injection of collagen (2 ml) in the knee joint affected by osteoarthritis
Intervention Type
Procedure
Intervention Name(s)
Placebo (saline solution)
Intervention Description
Patients will be treated with a single injections of saline solution (2 ml) in the knee joint affected by osteoarthritis
Primary Outcome Measure Information:
Title
KOOS-Pain Score
Description
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 Outcome Measure Information:
Title
IKDC-Subjective Score
Description
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
Title
KOOS Score
Description
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
Title
WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) score
Description
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
Title
VAS-pain (Visual Analogue Scale)
Description
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".
Time Frame
baseline, 1 month, 3 months, 6 months follow-up
Title
EQ-VAS
Description
EQ-VAS Is a visual analog scale that has a range of scores from 0 (worst imaginable health condition) to 100 (best imaginable health condition).
Time Frame
baseline, 1 month, 3 months, 6 months follow-up
Title
EQ-5D (EuroQoL) Current Health Assessment
Description
The EQ-5D profile, asks patients to classify their health based on self-assessed levels of problems ("no", "some", "extreme") on five dimensions.
Time Frame
baseline, 1 month, 3 months, 6 months follow-up
Title
TegnerActivity Level Scale
Description
Tegner activity level scale allows to know the level of physical activity carried out by the patients. Tegner's activity scale classifies the activity according to work and sports activities on a scale from 0 to 10. Zero represents disability because of knee problems and 10 represents soccer a national or international level
Time Frame
baseline, 1 month, 3 months, 6 months follow-up
Title
Patient Acceptable Symptom State (PASS)
Description
A tool to assess patient satisfaction in consideration of their current degree of pain, function, and daily activity. Patients can express if their state of health will be satisfying, answering "yes" or "no".
Time Frame
baseline, 1 month, 3 months, 6 months follow-up
Title
Objective parameters -Range of motion
Description
Evaluation of the Range of Motion for comparative analysis.
Time Frame
baseline, 1 month, 3 months, 6 months follow-up
Title
Final treatment opinion
Description
The patient should indicate satisfaction and relative degree with treatment at the end of the clinical trial (24 months follow-up). All patients will be able to indicate their health condition by choosing from this answers; "Full recovery", "much better", "somewhat better", "no change", "a little worse", "much worse".
Time Frame
6 months follow-up
Title
Ultrasound assessment
Description
This examination is useful to do an initial assessment of possible meniscal extrusion in the interested knee joint.
Time Frame
Baseline
Title
Thermographic evaluation of the inflammatory status of the knee joint
Description
The evaluation will be performed through the use of a thermal imaging camera. The thermal camera will allow to detect even small variation of knee temperature thus comparing and recording any thermographic changes in the inflammatory state of the joint before and after treatment.
Time Frame
baseline, 1 month, 3 months, 6 months follow-up
Title
Objective parameters - Circumferences
Description
Bilateral trans- and supra- patellar circumferences measurement for comparative analysis
Time Frame
baseline, 1 month, 3 months, 6 months follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Roberta Licciardi, Msc
Phone
0516366567
Email
roberta.licciardi@ior.it
First Name & Middle Initial & Last Name or Official Title & Degree
Alessandro Di Martino, MD
Email
alessandro.dimartino@ior.it
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alessandro Di Martino, MD
Organizational Affiliation
Istituto Ortopedico Rizzoli
Official's Role
Principal Investigator
Facility Information:
Facility Name
Istituto Ortopedico Rizzoli
City
Bologna
ZIP/Postal Code
40136
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alessandro Di Martino, MD
Phone
6366567
Ext
051
Email
alessandro.dimartino@ior.it
First Name & Middle Initial & Last Name & Degree
Roberta Licciardi, MSc
Phone
6366567
Ext
051
Email
roberta.licciardi@ior.it

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
27043347
Citation
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.
Results Reference
background
PubMed Identifier
32447428
Citation
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.
Results Reference
background
PubMed Identifier
31277508
Citation
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.
Results Reference
background
PubMed Identifier
31533151
Citation
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. Erratum In: J Knee Surg. 2019 Nov;32(11):e2.
Results Reference
background
PubMed Identifier
19453649
Citation
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.
Results Reference
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PubMed Identifier
25577327
Citation
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.
Results Reference
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Hydrolyzed Collagen Formulation vs Placebo in Knee Osteoarthritis

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