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Homologous PRP vs Placebo in Knee Osteoarthritis in Over 65 Years Old Patients

Primary Purpose

Knee Osteoarthritis

Status
Recruiting
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Homologous PRP injections
Placebo injection (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, PRP, Homologous PRP, PRP injections, injection treatment, Randomized controlled trial, osteoarthritis

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Unilateral involvement;
  2. Signs and symptoms of degenerative pathology of the knee cartilage;
  3. Radiographic or MRI signs of degenerative pathology of the knee cartilage (Kellgren-Lawrence 1-4 grades);
  4. Ability and consent of patients to actively participate in clinical follow-up;
  5. Signature of informed consent

Exclusion Criteria:

  1. Patients undergoing knee surgery within the previous 12 months;
  2. Patients with malignant neoplasms;
  3. Patients with rheumatic diseases;
  4. Patients with diabetes;
  5. Patients with hematologic diseases (coagulopathies);
  6. Patients with metabolic disorders of the thyroid gland;
  7. Patients abusing alcoholic beverages, drugs or medications
  8. Body Mass Index > 35

Sites / Locations

  • Istituto Ortopedico RizzoliRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Homologous PRP

Saline solution

Arm Description

This group of patients will be treated with single intra-articular injection of Homologous PRP. At the 6-month follow-up visit, the patient will be informed about the treatment received.

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

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
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.
Visual Analogue Scale (VAS)
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
EQ-5D is useful to evaluate the quality life of the patients
Tegner Activity Level Scale
Tegner activity level scale allows to know the level of physical activity carried out by the patients. All patients will indicate the type of sporting activity performed and its frequency.
Objective parameters- Range of Motion
Evaluation of the Range of Motion for comparative analysis.
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 - Circumferences
Bilateral trans- and supra- patellar circumferences measurement for comparative analysis

Full Information

First Posted
May 17, 2021
Last Updated
July 18, 2023
Sponsor
Istituto Ortopedico Rizzoli
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1. Study Identification

Unique Protocol Identification Number
NCT04901273
Brief Title
Homologous PRP vs Placebo in Knee Osteoarthritis in Over 65 Years Old Patients
Official Title
Homologous PRP Versus Placebo in the Infiltrative Treatment of Knee Osteoarthritis in Over 65 Years Old Patients.
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 15, 2021 (Actual)
Primary Completion Date
June 2025 (Anticipated)
Study Completion Date
June 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 injection of Homologous PRP versus single injection of placebo (saline solution) in the infiltrative treatment of knee osteoarthritis in over 65 years old patients. 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 RCT with possibility ,after 6 months, to cross-over from control arm ( saline solution ) to the treatment arm (Homologous PRP). Patients will be followed-up with clinical evaluation at 1,3 and 6 months. During the follow-up visits ,will be evaluated the inflammatory status of the knee by thermographic assessment. Patients in the treatment arm (Homologous PRP) will be followed for an additional 6 months (up to 12 months of follow-up). 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 12 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, PRP, Homologous PRP, PRP injections, injection treatment, Randomized controlled trial, osteoarthritis

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 (Homologous PRP). 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 12 months.
Masking
ParticipantOutcomes Assessor
Masking Description
This is a double-blind randomized controlled trial with 1:1 allocation. Patient blinding will be provided during the injection treatment.
Allocation
Randomized
Enrollment
204 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Homologous PRP
Arm Type
Experimental
Arm Description
This group of patients will be treated with single intra-articular injection of Homologous PRP. At the 6-month follow-up visit, the patient will be informed about the treatment received.
Arm Title
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)
Homologous PRP injections
Intervention Description
Patients will be treated with a single injection of Homologous PRP (5 ml) in the knee joint affected by osteoarthritis.
Intervention Type
Procedure
Intervention Name(s)
Placebo injection (saline solution)
Intervention Description
Patients will be treated with a single injections of saline solution (5 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 FU
Secondary Outcome Measure Information:
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 and 12 months follow-up
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 and 12 months follow-up
Title
Visual Analogue Scale (VAS)
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 and 12 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 and 12 months follow-up
Title
EQ-5D (EuroQoL) Current Health Assessment
Description
EQ-5D is useful to evaluate the quality life of the patients
Time Frame
baseline, 1 month, 3 months, 6 and 12 months follow-up
Title
Tegner Activity Level Scale
Description
Tegner activity level scale allows to know the level of physical activity carried out by the patients. All patients will indicate the type of sporting activity performed and its frequency.
Time Frame
baseline, 1 month, 3 months, 6 and 12 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 and 12 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 and 12 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 and 12 months follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Unilateral involvement; Signs and symptoms of degenerative pathology of the knee cartilage; Radiographic or MRI signs of degenerative pathology of the knee cartilage (Kellgren-Lawrence 1-4 grades); Ability and consent of patients to actively participate in clinical follow-up; Signature of informed consent Exclusion Criteria: 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 with metabolic disorders of the thyroid gland; Patients abusing alcoholic beverages, drugs or medications Body Mass Index > 35
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
30545242
Citation
Di Martino A, Di Matteo B, Papio T, Tentoni F, Selleri F, Cenacchi A, Kon E, Filardo G. Platelet-Rich Plasma Versus Hyaluronic Acid Injections for the Treatment of Knee Osteoarthritis: Results at 5 Years of a Double-Blind, Randomized Controlled Trial. Am J Sports Med. 2019 Feb;47(2):347-354. doi: 10.1177/0363546518814532. Epub 2018 Dec 13.
Results Reference
background
PubMed Identifier
22203046
Citation
Filardo G, Kon E, Pereira Ruiz MT, Vaccaro F, Guitaldi R, Di Martino A, Cenacchi A, Fornasari PM, Marcacci M. Platelet-rich plasma intra-articular injections for cartilage degeneration and osteoarthritis: single- versus double-spinning approach. Knee Surg Sports Traumatol Arthrosc. 2012 Oct;20(10):2082-91. doi: 10.1007/s00167-011-1837-x. Epub 2011 Dec 28.
Results Reference
background
PubMed Identifier
24634448
Citation
Braun HJ, Kim HJ, Chu CR, Dragoo JL. The effect of platelet-rich plasma formulations and blood products on human synoviocytes: implications for intra-articular injury and therapy. Am J Sports Med. 2014 May;42(5):1204-10. doi: 10.1177/0363546514525593. Epub 2014 Mar 14.
Results Reference
background
PubMed Identifier
24599205
Citation
Cavallo C, Filardo G, Mariani E, Kon E, Marcacci M, Pereira Ruiz MT, Facchini A, Grigolo B. Comparison of platelet-rich plasma formulations for cartilage healing: an in vitro study. J Bone Joint Surg Am. 2014 Mar 5;96(5):423-9. doi: 10.2106/JBJS.M.00726.
Results Reference
background
PubMed Identifier
16921694
Citation
Everts PA, Knape JT, Weibrich G, Schonberger JP, Hoffmann J, Overdevest EP, Box HA, van Zundert A. Platelet-rich plasma and platelet gel: a review. J Extra Corpor Technol. 2006 Jun;38(2):174-87.
Results Reference
background

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Homologous PRP vs Placebo in Knee Osteoarthritis in Over 65 Years Old Patients

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