Back to resultsUse of Leukocyte-Rich PRP or Leukocyte-Free PRP in the Treatment of Hip Osteoarthritis (PRP22-Hip)
Primary Purpose
Hip Osteoarthritis
Status
Recruiting
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Leukocyte Rich- PRP injection
Leukocyte Poor- PRP injection
Sponsored by
About this trial
This is an interventional treatment trial for Hip Osteoarthritis focused on measuring PRP, LR-PRP, LP-PRP, Platelet rich plasma, PRP injection, Leukocyte Rich-PRP, Leukocyte Poor-PRP, Hip-OA, Hip Osteoarthritis, Randomized controlled trial, Injection treatment
Eligibility Criteria
Inclusion Criteria:
- Signs and symptoms of hip OA (pain intensity of at least 4 points and not more than 8 of VAS pain - 0-10 scale in the previous week);
- Radiographic signs of hip OA (Grade 1-2 according to Tonnis classification) or MRI signs (chondropathy or minimal labrum degeneration without acute lesions) even if Grade 0.
- Unilateral involvement; Hemoglobin > 11 g/dl;
- Platelet count > 150,000 plt/mm3 (Recently performed CBC examination);
- Negative serological tests for HBsAg, HCV Ab, HIV-1-2 Ab
- No clinically significant electrocardiographic changes (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 undergoing infiltration of other substance in the previous 6 months;
- Patients undergoing lower limb surgery to be treated in the previous 12 months;
- Patients with malignant neoplasms;
- Patients with rheumatic diseases;- Patients with uncontrolled diabetes;-Patients with hematological diseases (coagulopathies);
- Patients on anticoagulant-antiaggregant therapy that cannot be discontinued for at least 3 days prior to blood collection;
- Patients with uncontrolled thyroid metabolic disorders;
- Patients abusing alcoholic beverages, drugs or medications;
- Body Mass Index > 30;
- Patients who have taken NSAIDs in the 3 days prior to blood draw;
- Patients with cardiovascular disease for whom 300 ml blood draw would be contraindicated;
- Patients with recently performed CBC examination with Hb< 11 g/dl and Platelet values < 150,000 plt/mm3.
- Positive serological tests for HBsAg, HCV Ab, HIV-1-2 Ab
- Pregnant and/or fertile women.
- Pain intensity less than 4 points or greater than 8 in accordance with the VAS scale.
- Patients with other hip pathologies: acetabular protrusion, concentric migration of the femoral head, presence of excessive deformity resulting from acetabular or femoral head dysplasia, collapse deformity, and deformed femoral head sequelae of Perthes disease or osteonecrosis of the femoral head.
- Previous extensive surgery of the reference joint (osteotomy around the hip, open or arthroscopic osteochondroplasty for femoro-acetabular conflict).
Sites / Locations
- Istituto Ortopedico RizzoliRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Leukocyte Rich-PRP Injection
Leukocyte Poor- PRP Injection
Arm Description
Three infiltrations of Leukocyte Rich Platelet Rich Plasma 1 infiltration weekly, for 3 weeks
Three infiltrations of Leukocyte Poor-Platelet Rich Plasma 1 infiltration weekly, for 3 weeks.
Outcomes
Primary Outcome Measures
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
It's a standardized and widely used questionnaire to assess the condition of patients with osteoarthritis of the knee and includes assessment of pain, stiffness, and physical function of the joints. It can be administered to the patient.
It measures 5 items for pain (range 0-20), two for stiffness (range 0-8), and 17 for functional limitation (range 0-68) that mainly relate to activities of daily living (e.g., getting up from a sitting position, bending over, going up and down stairs etc.); The score is then normalized on a 0-100 scale. Higher values indicate a worse outcome
Secondary Outcome Measures
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
It's a standardized and widely used questionnaire to assess the condition of patients with osteoarthritis of the knee and includes assessment of pain, stiffness, and physical function of the joints. It can be administered to the patient.
It measures 5 items for pain (range 0-20), two for stiffness (range 0-8), and 17 for functional limitation (range 0-68) that mainly relate to activities of daily living (e.g., getting up from a sitting position, bending over, going up and down stairs etc.); The score is then normalized on a 0-100 scale. Higher values indicate a worse outcome
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".
Harris Hip Scale (HHS)
This scale was developed for the evaluation of hip surgery outcomes and is intended to assess various hip disabilities and treatment methods in an adult population. The four sections that make up the questionnaire are: pain, function, absence of deformity, and range of motion. The HHS is a measure of dysfunction, so higher is the score, better is the outcome for the individual. The maximum possible score is 100.
EQ-5D (EuroQoL) Current Health Assessment
EQ-5D is a standardized measure of health-related quality of life developed by the EuroQol Group to provide a simple generic questionnaire for use in clinical and economic evaluation and population health surveys
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.
Full Information
NCT ID
NCT05497349
First Posted
August 9, 2022
Last Updated
September 10, 2023
Sponsor
Istituto Ortopedico Rizzoli
1. Study Identification
Unique Protocol Identification Number
NCT05497349
Brief Title
Use of Leukocyte-Rich PRP or Leukocyte-Free PRP in the Treatment of Hip Osteoarthritis
Acronym
PRP22-Hip
Official Title
Use of Leukocyte-Rich PRP or Leukocyte-Free PRP in the Treatment of Hip Osteoarthritis. Double-blind Controlled Randomized Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 5, 2022 (Actual)
Primary Completion Date
October 2026 (Anticipated)
Study Completion Date
October 2026 (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 efficacy up to 12 months of two different types of PRP (PRP with leukocytes vs PRP depleted of leukocytes) in the echo-guided infiltrative treatment of hip OA by including 230 patients in the study and evaluating them through subjective (using the WOMAC score as the primary outcome) and objective clinical scores.
Detailed Description
Platelet-rich plasma (PRP) has recently emerged as an attractive biological approach to address joint degeneration. It has gained increasing attention because of the high concentration of growth factors, cytokines, and bioactive molecules stored in platelet-rich α-granules, which have been shown to participate in joint tissue homeostasis, being involved in both healing processes and immunoregulation and modulation of inflammation. Several preparation methods are available for PRP, which can give products with different compositions and characteristics.The presence of leukocytes is one of the most debated aspects of PRP efficacy, and is used as one of the main discriminators to distinguish different PRPs.
Patients with OA of the hip will be included in a randomized controlled, double-blind trial, in which one group of patients will be treated with 3 infiltrations of PRP with leukocytes and one group will be treated instead with 3 infiltrations of PRP without leukocytes. A total of 230 patients will be included and will undergo infiltrative treatment after collecting informed consent for study participation. Patients will be clinically evaluated before the injection procedure and at 2-6-12 months after treatment by the medical staff.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hip Osteoarthritis
Keywords
PRP, LR-PRP, LP-PRP, Platelet rich plasma, PRP injection, Leukocyte Rich-PRP, Leukocyte Poor-PRP, Hip-OA, Hip Osteoarthritis, Randomized controlled trial, Injection treatment
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 3 intra-articular injection of Leukocyte Rich-PRP, and one group will be treated with 3 intra-articular injection of Leukocyte Poor- PRP
Masking
ParticipantOutcomes Assessor
Masking Description
This is a double-blind randomized controlled trial with allocation 1:1. Patient blinding will be provided during the injection treatment.
Allocation
Randomized
Enrollment
230 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Leukocyte Rich-PRP Injection
Arm Type
Experimental
Arm Description
Three infiltrations of Leukocyte Rich Platelet Rich Plasma
1 infiltration weekly, for 3 weeks
Arm Title
Leukocyte Poor- PRP Injection
Arm Type
Active Comparator
Arm Description
Three infiltrations of Leukocyte Poor-Platelet Rich Plasma
1 infiltration weekly, for 3 weeks.
Intervention Type
Other
Intervention Name(s)
Leukocyte Rich- PRP injection
Intervention Description
Autologous Leukocyte Rich-Platelet Rich Plasma will be injected in the hip joint
Intervention Type
Other
Intervention Name(s)
Leukocyte Poor- PRP injection
Intervention Description
Autologous Leukocyte Poor-Platelet Rich Plasma will be injected in the hip joint
Primary Outcome Measure Information:
Title
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Description
It's a standardized and widely used questionnaire to assess the condition of patients with osteoarthritis of the knee and includes assessment of pain, stiffness, and physical function of the joints. It can be administered to the patient.
It measures 5 items for pain (range 0-20), two for stiffness (range 0-8), and 17 for functional limitation (range 0-68) that mainly relate to activities of daily living (e.g., getting up from a sitting position, bending over, going up and down stairs etc.); The score is then normalized on a 0-100 scale. Higher values indicate a worse outcome
Time Frame
6 months follow-up
Secondary Outcome Measure Information:
Title
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Description
It's a standardized and widely used questionnaire to assess the condition of patients with osteoarthritis of the knee and includes assessment of pain, stiffness, and physical function of the joints. It can be administered to the patient.
It measures 5 items for pain (range 0-20), two for stiffness (range 0-8), and 17 for functional limitation (range 0-68) that mainly relate to activities of daily living (e.g., getting up from a sitting position, bending over, going up and down stairs etc.); The score is then normalized on a 0-100 scale. Higher values indicate a worse outcome
Time Frame
baseline, 2 month and 12 months
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 months, 6 months and 12 months follow-up
Title
Harris Hip Scale (HHS)
Description
This scale was developed for the evaluation of hip surgery outcomes and is intended to assess various hip disabilities and treatment methods in an adult population. The four sections that make up the questionnaire are: pain, function, absence of deformity, and range of motion. The HHS is a measure of dysfunction, so higher is the score, better is the outcome for the individual. The maximum possible score is 100.
Time Frame
baseline, 2 months, 6 months and 12 months follow-up
Title
EQ-5D (EuroQoL) Current Health Assessment
Description
EQ-5D is a standardized measure of health-related quality of life developed by the EuroQol Group to provide a simple generic questionnaire for use in clinical and economic evaluation and population health surveys
Time Frame
baseline, 2 months, 6 months 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, 2 months, 6 months and 12 months follow-up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Signs and symptoms of hip OA (pain intensity of at least 4 points and not more than 8 of VAS pain - 0-10 scale in the previous week);
Radiographic signs of hip OA (Grade 1-2 according to Tonnis classification) or MRI signs (chondropathy or minimal labrum degeneration without acute lesions) even if Grade 0.
Unilateral involvement; Hemoglobin > 11 g/dl;
Platelet count > 150,000 plt/mm3 (Recently performed CBC examination);
Negative serological tests for HBsAg, HCV Ab, HIV-1-2 Ab
No clinically significant electrocardiographic changes (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 undergoing infiltration of other substance in the previous 6 months;
Patients undergoing lower limb surgery to be treated in the previous 12 months;
Patients with malignant neoplasms;
Patients with rheumatic diseases;- Patients with uncontrolled diabetes;-Patients with hematological diseases (coagulopathies);
Patients on anticoagulant-antiaggregant therapy that cannot be discontinued for at least 3 days prior to blood collection;
Patients with uncontrolled thyroid metabolic disorders;
Patients abusing alcoholic beverages, drugs or medications;
Body Mass Index > 30;
Patients who have taken NSAIDs in the 3 days prior to blood draw;
Patients with cardiovascular disease for whom 300 ml blood draw would be contraindicated;
Patients with recently performed CBC examination with Hb< 11 g/dl and Platelet values < 150,000 plt/mm3.
Positive serological tests for HBsAg, HCV Ab, HIV-1-2 Ab
Pregnant and/or fertile women.
Pain intensity less than 4 points or greater than 8 in accordance with the VAS scale.
Patients with other hip pathologies: acetabular protrusion, concentric migration of the femoral head, presence of excessive deformity resulting from acetabular or femoral head dysplasia, collapse deformity, and deformed femoral head sequelae of Perthes disease or osteonecrosis of the femoral head.
Previous extensive surgery of the reference joint (osteotomy around the hip, open or arthroscopic osteochondroplasty for femoro-acetabular conflict).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dante Dallari, MD
Phone
6366318
Ext
051
Email
dante.dallari@ior.it
First Name & Middle Initial & Last Name or Official Title & Degree
Roberta Licciardi, MSc
Phone
6366567
Ext
051
Email
roberta.licciardi@ior.it
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dante Dallari, 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
Dante Dallari, MD
Phone
6366567
First Name & Middle Initial & Last Name & Degree
Roberta, MSc
Phone
6366567
Ext
051
Email
roberta.licciardi@ior.it
12. IPD Sharing Statement
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Use of Leukocyte-Rich PRP or Leukocyte-Free PRP in the Treatment of Hip Osteoarthritis
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