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The Efficacy of LPPRP in the Treatment of Chondromalacia Patella (LPPRP)

Primary Purpose

Chondromalacia Patellae

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Exercise
LP-PRP
Sponsored by
Kayseri City Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chondromalacia Patellae focused on measuring Chondromalacia Patellae, leukocyte-poor platelet-rich plasma, magnetic resonance imaging

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Chondromalasia Patella stage 2 and above in MRI requested from patients with chronic pain around the patella, who have increased pain in at least one of the activities that carry loads while the knee is flexed (squatting, stepping, running, jumping, jumping) after physical examination and clinical evaluation Patients with VAS 3 and above Patients over 18 years of age Patients without any deformity in the lower extremity Exclusion Criteria: Coagulopathy and/or thrombocytopenia Cardiovascular instability or severe disease condition Presence of systemic infection or malignancy Pregnancy Intra-articular injection in the last 6 months Stage 3 and above meniscopathy in MRI Evidence or suspicion of rupture of the anterior cruciate ligament on MRI

Sites / Locations

  • Health Sciences University, Kayseri Medicine Faculty

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Control Group

LP-PRP Group

Arm Description

First group (14 people): 4-weeks home exercise program will be given to control group. The exercise program includes quadriceps isometric exercises (holding for 10 seconds, 20 reps), straight leg raises (20 reps holding for 6 seconds), and semi-squatting exercises (20 reps), hip flexors, hamstring and iliotibial band stretching exercises (20-repetitions), strengthening exercises for hip abductors and adductors (holding for 6 seconds with 20 repetitions). These exercises were said to be performed for 30 minutes, once a day, every day for 4 weeks.

Second group (14 people): LP-PRP injection and 4-week exercise program will be applied by targeting the suprapatellar bursa. The LP-PRPs to be applied will be obtained by centrifugation of the venous blood taken from the patients by manual methods.

Outcomes

Primary Outcome Measures

Western Ontario & McMaster Universities Osteoarthritis Index (WOMAC)
It is a disease-specific measurement for knee and hip osteoarthritis. WOMAC is a personalized index with 5 questions for pain, 2 for stiffness, and 17 questions for questioning daily activities. It has different scores from 0 to 4 (0: none, 1: mild, 2: moderate, 3: severe, 4: very severe). Scale lengths of subheadings; pain=20, stiffness=8, physical function=68. Turkish validation is available . A high score indicates poor health.

Secondary Outcome Measures

MRI cartilage thickness
MRI protocol; Proton density (PD-TSE) sagittal, proton density fat suppressed (PD-TSE-FS) coronal, T2W axial and T1W sagittal sequences were taken. Cartilage thickness measurements (millimeter) were measured in the medial and lateral facets where the cartilage was thickest and averaged. In addition, cartilage thickness was measured at the level of the defective area. A low score indicates poor health.
MRI defective cartilage thickness
MRI protocol; Proton density (PD-TSE) sagittal, proton density fat suppressed (PD-TSE-FS) coronal, T2W axial and T1W sagittal sequences were taken. Cartilage thickness measurements (millimeter) were measured in the medial and lateral facets where the cartilage was thickest and averaged. In addition, cartilage thickness was measured at the level of the defective area. A low score indicates poor health.
MRI Outerbridge Staging
MRI protocol; Proton density (PD-TSE) sagittal, proton density fat suppressed (PD-TSE-FS) coronal, T2W axial and T1W sagittal sequences were taken. The CP stage was performed with the Outerbridge Staging System. According to this staging system, normal cartilage is stage 0; softening or edema without cartilage surface irregularity, stage 1; fragmentation of cartilage, fissure formation or focal defect below 50%, stage 2; Fragmentation, fissure formation or defect in 50% or more cartilage, stage 3; ulceration in the cartilage and exposure of the subchondral bone or increased signal in the exposed subchondral bone were classified as stage 4. A high score indicates poor health.

Full Information

First Posted
August 9, 2023
Last Updated
August 26, 2023
Sponsor
Kayseri City Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT06020794
Brief Title
The Efficacy of LPPRP in the Treatment of Chondromalacia Patella
Acronym
LPPRP
Official Title
The Efficacy of Leukocyte-poor Platelet Rich Plasma (LPPRP) in the Treatment of Chondromalacia Patella - Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
February 1, 2021 (Actual)
Primary Completion Date
August 1, 2022 (Actual)
Study Completion Date
November 4, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kayseri City Hospital

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
Chondromalacia patella(CP) is a common cause of anterior knee pain in the population under 50 years of age. CP is characterized by softening or varying degrees of damage to the patellar cartilage. The positive effects of leukocyte poor-platelet rich plasma (leukocyte poor-platelet rich plasma, LP-PRP) on cartilage repair and degenerative findings are known. However, there is no randomized controlled study on this subject in CP. The aim of this study is to investigate the effect of LP-PRP on pain, function, walking distance and magnetic resonance imaging (MRI) findings in CP patients.The study is the first to investigate the effect of LP-PRP on cartilage measurement with MRI in Chondromalasia Patella. Patients with anterior knee pain who applied to the physical therapy and rehabilitation outpatient clinic of Kayseri City Hospital, patients with Chondromalacia patella in MRI will be included in the study. A total of 40 patients will be randomized into 2 groups. The exercise program will be applied to both groups as a home program for 4 weeks.
Detailed Description
A randomized, prospective, controlled study included 28 patients with MRI stage 2 and above Chondromalasia Patella findings. The patients were randomized into 2 groups, group 1 (the group in which 2 doses of suprapatellar bursa were injected with 2 doses of 3 cc LP-PRP at 1-week intervals and a 4-week home exercise program was given) and group 2 (the control group, the group given a 4-week home exercise program). Patients were tested on the Visual Analogue Scale (VAS) day, night and motion, Western Ontario McMaster Universities Osteoarthritis Index (WOMAC), 6-minute walk test (6MWT) at baseline,1st week, 4th week and 12th week and cartilage thickness, including defective cartilage thickness, and Chondromalasia Patella Outerbridge Staging were evaluated on MRI at baseline and 12th week. WOMAC value was taken as the primary outcome measure and MRI cartilage values were taken as the secondary outcome measure. Clinic Responsible for Research: Physical Therapy and Rehabilitation Clinic of Kayseri City Hospital

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chondromalacia Patellae
Keywords
Chondromalacia Patellae, leukocyte-poor platelet-rich plasma, magnetic resonance imaging

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
RANDOMIZED CONTROLLED
Masking
Investigator
Allocation
Randomized
Enrollment
28 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control Group
Arm Type
Active Comparator
Arm Description
First group (14 people): 4-weeks home exercise program will be given to control group. The exercise program includes quadriceps isometric exercises (holding for 10 seconds, 20 reps), straight leg raises (20 reps holding for 6 seconds), and semi-squatting exercises (20 reps), hip flexors, hamstring and iliotibial band stretching exercises (20-repetitions), strengthening exercises for hip abductors and adductors (holding for 6 seconds with 20 repetitions). These exercises were said to be performed for 30 minutes, once a day, every day for 4 weeks.
Arm Title
LP-PRP Group
Arm Type
Active Comparator
Arm Description
Second group (14 people): LP-PRP injection and 4-week exercise program will be applied by targeting the suprapatellar bursa. The LP-PRPs to be applied will be obtained by centrifugation of the venous blood taken from the patients by manual methods.
Intervention Type
Behavioral
Intervention Name(s)
Exercise
Intervention Description
quadriceps isometric exercises, straight leg raises, semi-squat exercises, hip flexors, hamstring and iliotibial band stretching exercises, strengthening exercises for hip abductors and adductors
Intervention Type
Biological
Intervention Name(s)
LP-PRP
Intervention Description
The LP-PRPs to be applied will be obtained by centrifugation of the venous blood taken from the patients by manual methods.
Primary Outcome Measure Information:
Title
Western Ontario & McMaster Universities Osteoarthritis Index (WOMAC)
Description
It is a disease-specific measurement for knee and hip osteoarthritis. WOMAC is a personalized index with 5 questions for pain, 2 for stiffness, and 17 questions for questioning daily activities. It has different scores from 0 to 4 (0: none, 1: mild, 2: moderate, 3: severe, 4: very severe). Scale lengths of subheadings; pain=20, stiffness=8, physical function=68. Turkish validation is available . A high score indicates poor health.
Time Frame
at baseline, 1st week, 4th week and 12th week
Secondary Outcome Measure Information:
Title
MRI cartilage thickness
Description
MRI protocol; Proton density (PD-TSE) sagittal, proton density fat suppressed (PD-TSE-FS) coronal, T2W axial and T1W sagittal sequences were taken. Cartilage thickness measurements (millimeter) were measured in the medial and lateral facets where the cartilage was thickest and averaged. In addition, cartilage thickness was measured at the level of the defective area. A low score indicates poor health.
Time Frame
at baseline and 12th week
Title
MRI defective cartilage thickness
Description
MRI protocol; Proton density (PD-TSE) sagittal, proton density fat suppressed (PD-TSE-FS) coronal, T2W axial and T1W sagittal sequences were taken. Cartilage thickness measurements (millimeter) were measured in the medial and lateral facets where the cartilage was thickest and averaged. In addition, cartilage thickness was measured at the level of the defective area. A low score indicates poor health.
Time Frame
at baseline and 12th week
Title
MRI Outerbridge Staging
Description
MRI protocol; Proton density (PD-TSE) sagittal, proton density fat suppressed (PD-TSE-FS) coronal, T2W axial and T1W sagittal sequences were taken. The CP stage was performed with the Outerbridge Staging System. According to this staging system, normal cartilage is stage 0; softening or edema without cartilage surface irregularity, stage 1; fragmentation of cartilage, fissure formation or focal defect below 50%, stage 2; Fragmentation, fissure formation or defect in 50% or more cartilage, stage 3; ulceration in the cartilage and exposure of the subchondral bone or increased signal in the exposed subchondral bone were classified as stage 4. A high score indicates poor health.
Time Frame
at baseline and 12th week
Other Pre-specified Outcome Measures:
Title
Visual analog scale (VAS)
Description
It is used to numerically express the pain felt by the patient. A 100 mm line is drawn and one end is no pain (0), and the other end is unbearable pain (100). The patient is asked to indicate his or her pain state on this line. The distance from the point indicated by the patient to the 0 point indicates the patient's pain. The pain experienced by the patients at rest, during the day and at night in the last 2 weeks was questioned and recorded. A high score indicates poor health.
Time Frame
at baseline, 1st week, 4th week and 12th week
Title
Six minute walk test
Description
It is a test used to reveal submaximal functional performance. The test should be performed in a closed, quiet environment of at least 30 meters, marked every 3 meters, and in a straight corridor. The patient should be warned to wear comfortable clothes and suitable shoes. The turning points during walking should be marked with the help of a cone and the patient should be asked to go around this cone. The test is terminated by calculating the total distance walked in six minutes.A low score indicates poor health.
Time Frame
at baseline, 1st week, 4th week and 12th week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Chondromalasia Patella stage 2 and above in MRI requested from patients with chronic pain around the patella, who have increased pain in at least one of the activities that carry loads while the knee is flexed (squatting, stepping, running, jumping, jumping) after physical examination and clinical evaluation Patients with VAS 3 and above Patients over 18 years of age Patients without any deformity in the lower extremity Exclusion Criteria: Coagulopathy and/or thrombocytopenia Cardiovascular instability or severe disease condition Presence of systemic infection or malignancy Pregnancy Intra-articular injection in the last 6 months Stage 3 and above meniscopathy in MRI Evidence or suspicion of rupture of the anterior cruciate ligament on MRI
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Havva Prof. Dr. TALAY ÇALIŞ
Organizational Affiliation
Health Sciences University, Kayseri City Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Health Sciences University, Kayseri Medicine Faculty
City
Kayseri
Country
Turkey

12. IPD Sharing Statement

Learn more about this trial

The Efficacy of LPPRP in the Treatment of Chondromalacia Patella

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