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PRP Versus HA IN OSTEOARTHRITIS OF THE PATELLOFEMORAL JOINT

Primary Purpose

Patellofemoral Osteoarthritis

Status

Recruiting

Phase

Not Applicable

Locations

Italy

Study Type

Interventional

Intervention

Autologous PRP injection

HA injection

About this trial

This is an interventional treatment trial for Patellofemoral Osteoarthritis focused on measuring PRP, HA, Osteoarthritis, Autologous PRP, PRP injection, HA injection, injection treatment, Randomized controlled trial, Hyaluronic Acid, Platelet rich plasma

Eligibility Criteria

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

Inclusion Criteria:

Age between 30 and 65;
Signs and symptoms of isolated patellofemoral osteoarthritis present in one or both knees;
Radiographic signs of isolated patellofemoral osteoarthritis (according to Iwano et al stage 1-3 classification) or chondropathy (assessed on MRI) with K-L grade of the other compartments ≤ 2. [PMID: 2302884 - PMID: 27979409] ;
Hemoglobin > 11 g/dl; Platelet count > 150,000 plt/mm3 (Recently performed CBC exam);
No clinically significant electrocardiographic alterations (Recently performed ECG).
Ability and consent of patients to actively participate in clinical follow-up;
Signature of informed consent.

Exclusion Criteria:

Patients unable to express consent;
Patients who have undergone intra-articular infiltration of another substance within 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-antiaggregant therapy;
Patients with thyroid metabolic disorders;
Patients abusing alcoholic beverages, drugs or medications;
Body Mass Index > 35;
Patients who have taken NSAIDs in the 3 days prior to blood draw;
Patients with cardiovascular disease for which a 60 mL blood draw would be contraindicated;
Patients with a recently performed blood test with Hb< 11 g/dl and Platelets < 150,000 plt/mm3.
Previous treatment of patellar dislocation
Iwano score of grade 4.

Sites / Locations

Istituto Ortopedico RizzoliRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Autologous PRP injection

HA injection

Arm Description

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

This group of patients will be treated with single intra-articular injection of Hyaluronic Acid (HA)

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-Pain Score

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.

Objective parameters - Circumferences

Bilateral trans- and supra- patellar circumferences measurement 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.

The Kujala Anterior Knee Pain Scale (AKPS)

It's a 100-point scale consisting of 13 items with a score ranging from 5 to 10 points per item. A score of 0 points indicates the most severe limitation, while a score of 100 points indicates a normal situation.

Full Information

NCT ID

NCT04937998

First Posted

June 18, 2021

Last Updated

May 9, 2023

Sponsor

Istituto Ortopedico Rizzoli

1. Study Identification

Unique Protocol Identification Number

NCT04937998

Brief Title

PRP Versus HA IN OSTEOARTHRITIS OF THE PATELLOFEMORAL JOINT

Official Title

THE USE OF FRESH PRP VS HA IN THE TREATMENT OF OSTEOARTHRITIS OF THE PATELLOFEMORAL JOINT Randomized Controlled Clinical Trial

Study Type

Interventional

2. Study Status

Record Verification Date

May 2023

Overall Recruitment Status

Recruiting

Study Start Date

October 26, 2022 (Actual)

Primary Completion Date

October 2024 (Anticipated)

Study Completion Date

October 2024 (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

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

The aim of the study is to compare the 12-month clinical outcomes of patients with patellofemoral osteoarthritis undergoing infiltrative treatment with fresh PRP and HA

Detailed Description

166 patients affected by patellofemoral osteoarthritis will be included in a double-blinded RCT. In this study one group of patients will be treated with 1 intra-articular injection of PRP (treatment arm) and one group will be treated with 1 intra-articular injection of HA (control arm). Patients will be followed-up with clinical evaluation at baseline and at 2.6.12 and 24 months. Questionnaires will be administered for clinical evaluations during the follow-up visits.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Patellofemoral Osteoarthritis

Keywords

PRP, HA, Osteoarthritis, Autologous PRP, PRP injection, HA injection, injection treatment, Randomized controlled trial, Hyaluronic Acid, Platelet rich plasma

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

The study is a double-blinded RCT in which one group of patients will be treated with 1 intra-articular injection of fresh PRP, and one group will be treated with 1 intra-articular injection of HA.

Masking

ParticipantOutcomes Assessor

Masking Description

This is a double-blinded randomized controlled trial with 1:1 allocation.Patient blinding will be provided during the injection treatment.

Allocation

Randomized

Enrollment

166 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Autologous PRP injection

Arm Type

Experimental

Arm Description

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

Arm Title

HA injection

Arm Type

Active Comparator

Arm Description

This group of patients will be treated with single intra-articular injection of Hyaluronic Acid (HA)

Intervention Type

Procedure

Intervention Name(s)

Autologous PRP injection

Intervention Description

Patients will be treated with a single injection of Autologous PRP (5 ml) in the knee joint affected by patellofemoral osteoarthritis

Intervention Type

Procedure

Intervention Name(s)

HA injection

Intervention Description

Patients will be treated with a single injections of Hyaluronic Acid (5 ml) in the knee joint affected by patellofemoral osteoarthritis

Primary Outcome Measure Information:

Title

KOOS-Pain Score

Description

Time Frame

12 months

Secondary Outcome Measure Information:

Title

IKDC-Subjective Score

Description

Time Frame

baseline, 2 month, 6 months, 12 months , 24 months follow-up

Title

KOOS-Pain Score

Description

Time Frame

baseline, 2 month, 6 months , 24 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, 2 month, 6 months, 12 months , 24 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, 2 month, 6 months, 12 months , 24 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, 2 month, 6 months, 12 months , 24 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, 2 month, 6 months, 12 months , 24 months follow-up

Title

Objective parameters- Range of Motion

Description

Evaluation of the Range of Motion for comparative analysis.

Time Frame

baseline, 2 month, 6 months, 12 months , 24 months follow-up

Title

Objective parameters - Circumferences

Description

Bilateral trans- and supra- patellar circumferences measurement for comparative analysis

Time Frame

baseline, 2 month, 6 months, 12 months , 24 months follow-up

Title

Patient Acceptable Symptom State (PASS)

Description

Time Frame

baseline, 2 month, 6 months, 12 months , 24 months follow-up

Title

The Kujala Anterior Knee Pain Scale (AKPS)

Description

Time Frame

baseline, 2 month, 6 months, 12 months , 24 months follow-up

10. Eligibility

Sex

All

Minimum Age & Unit of Time

30 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Age between 30 and 65; Signs and symptoms of isolated patellofemoral osteoarthritis present in one or both knees; Radiographic signs of isolated patellofemoral osteoarthritis (according to Iwano et al stage 1-3 classification) or chondropathy (assessed on MRI) with K-L grade of the other compartments ≤ 2. [PMID: 2302884 - PMID: 27979409] ; Hemoglobin > 11 g/dl; Platelet count > 150,000 plt/mm3 (Recently performed CBC exam); No clinically significant electrocardiographic alterations (Recently performed ECG). Ability and consent of patients to actively participate in clinical follow-up; Signature of informed consent. Exclusion Criteria: Patients unable to express consent; Patients who have undergone intra-articular infiltration of another substance within 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-antiaggregant therapy; Patients with thyroid metabolic disorders; Patients abusing alcoholic beverages, drugs or medications; Body Mass Index > 35; Patients who have taken NSAIDs in the 3 days prior to blood draw; Patients with cardiovascular disease for which a 60 mL blood draw would be contraindicated; Patients with a recently performed blood test with Hb< 11 g/dl and Platelets < 150,000 plt/mm3. Previous treatment of patellar dislocation Iwano score of grade 4.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Roberta Licciardi, MSc

Phone

0516366567

roberta.licciardi@ior.it

First Name & Middle Initial & Last Name or Official Title & Degree

Alessandro Di Martino, MD

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

Country

Italy

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Alessandro Di Martino, MD

Phone

6366567

Ext

051

alessandro.dimartino@ior.it

First Name & Middle Initial & Last Name & Degree

Roberta Licciardi, MSc

Phone

6366567

Ext

051

roberta.licciardi@ior.it

12. IPD Sharing Statement

Plan to Share IPD

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

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

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

27979409

Citation

deDeugd CM, Pareek A, Krych AJ, Cummings NM, Dahm DL. Outcomes of Patellofemoral Arthroplasty Based on Radiographic Severity. J Arthroplasty. 2017 Apr;32(4):1137-1142. doi: 10.1016/j.arth.2016.11.006. Epub 2016 Nov 15.

Results Reference

background

PubMed Identifier

24942296

Citation

Assirelli E, Filardo G, Mariani E, Kon E, Roffi A, Vaccaro F, Marcacci M, Facchini A, Pulsatelli L. Effect of two different preparations of platelet-rich plasma on synoviocytes. Knee Surg Sports Traumatol Arthrosc. 2015 Sep;23(9):2690-703. doi: 10.1007/s00167-014-3113-3. Epub 2014 Jun 19.

Results Reference

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PRP Versus HA IN OSTEOARTHRITIS OF THE PATELLOFEMORAL JOINT

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