- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06020794
The Efficacy of LPPRP in the Treatment of Chondromalacia Patella (LPPRP)
The Efficacy of Leukocyte-poor Platelet Rich Plasma (LPPRP) in the Treatment of Chondromalacia Patella - Randomized Controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
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
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Kayseri, Turkey
- Health Sciences University, Kayseri Medicine Faculty
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Control Group
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.
|
quadriceps isometric exercises, straight leg raises, semi-squat exercises, hip flexors, hamstring and iliotibial band stretching exercises, strengthening exercises for hip abductors and adductors
|
Active Comparator: LP-PRP Group
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.
|
quadriceps isometric exercises, straight leg raises, semi-squat exercises, hip flexors, hamstring and iliotibial band stretching exercises, strengthening exercises for hip abductors and adductors
The LP-PRPs to be applied will be obtained by centrifugation of the venous blood taken from the patients by manual methods.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Western Ontario & McMaster Universities Osteoarthritis Index (WOMAC)
Time Frame: at baseline, 1st week, 4th week and 12th week
|
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.
|
at baseline, 1st week, 4th week and 12th week
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
MRI cartilage thickness
Time Frame: at baseline and 12th week
|
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.
|
at baseline and 12th week
|
MRI defective cartilage thickness
Time Frame: at baseline and 12th week
|
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.
|
at baseline and 12th week
|
MRI Outerbridge Staging
Time Frame: at baseline and 12th week
|
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.
|
at baseline and 12th week
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Visual analog scale (VAS)
Time Frame: at baseline, 1st week, 4th week and 12th week
|
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.
|
at baseline, 1st week, 4th week and 12th week
|
Six minute walk test
Time Frame: at baseline, 1st week, 4th week and 12th week
|
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.
|
at baseline, 1st week, 4th week and 12th week
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Havva Prof. Dr. TALAY ÇALIŞ, Health Sciences University, Kayseri City Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- KayseriCH
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Chondromalacia Patellae
-
University of Sao Paulo General HospitalCompleted
-
Cairo UniversityNot yet recruiting
-
Instituto Mexicano del Seguro SocialCompletedChondromalacia PatellaeMexico
-
University of VirginiaCompletedPatellofemoral Pain Syndrome | Chondromalacia PatellaUnited States
-
Cairo UniversityCompletedIs Lower Limb Neuromotor Control Diverse in Females With PF OA Contrasted With Asymptomatic ControlsChondromalacia PatellaeEgypt
-
Sheba Medical CenterZinman College of Physical Education and Sports SciencesUnknownCartilage Diseases | ChondromalaciaIsrael
-
Gaziler Physical Medicine and Rehabilitation Education...RecruitingChondromalacia PatellaeTurkey
-
Gaziler Physical Medicine and Rehabilitation Education...CompletedChondromalacia PatellaeTurkey
-
Cairo UniversityCompletedChondromalacia PatellaeEgypt
-
Cairo UniversityCompletedChondromalacia PatellaeEgypt
Clinical Trials on Exercise
-
University of Kansas Medical CenterRecruiting
-
National Institute of Neurological Disorders and...TerminatedTraumatic Brain InjuryUnited States
-
University of Texas, El PasoRecruitingKnee Osteoarthritis | Knee Pain Chronic | Central Pain SyndromeUnited States
-
Toronto Rehabilitation InstituteCompletedAcute Myeloid LeukemiaCanada
-
Sahmyook UniversityRecruitingChronic Nonspecific Neck PainKorea, Republic of
-
University of AlbertaWomen and Children's Health Research Institute, CanadaRecruitingType 1 Diabetes | Post-menopauseCanada
-
Uskudar UniversityCompleted
-
Yuksek Ihtisas UniversityCompletedDementia | Frailty | Cognitive Function | Reaction Time | Aerobic Exercise | Balance ExerciseTurkey
-
National Taiwan Normal UniversityCompletedAging | Cognitive DeclineTaiwan
-
Wayne State UniversityUnknown