Clinical trial NCT06020794: The Efficacy of LPPRP in the Treatment of Chondromalacia Patella
Official title: The Efficacy of Leukocyte-poor Platelet Rich Plasma (LPPRP) in the Treatment of Chondromalacia Patella - Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chondromalacia Patellae
Keywords: Chondromalacia Patellae
leukocyte-poor platelet-rich plasma
magnetic resonance imaging
Lead sponsor: Kayseri City Hospital
Sponsor class: OTHER_GOV
First posted: 2023-09-01
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: RANDOMIZED CONTROLLED
Primary purpose: TREATMENT

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

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

Primary outcomes:
measure: Western Ontario & McMaster Universities Osteoarthritis Index (WOMAC)
timeFrame: at baseline, 1st week, 4th week and 12th week
Secondary outcomes:
measure: MRI cartilage thickness
timeFrame: at baseline and 12th week
measure: MRI defective cartilage thickness
timeFrame: at baseline and 12th week
measure: MRI Outerbridge Staging
timeFrame: at baseline and 12th week
Other outcomes:
measure: Visual analog scale (VAS)
timeFrame: at baseline, 1st week, 4th week and 12th week
measure: Six minute walk test
timeFrame: at baseline, 1st week, 4th week and 12th week
Locations:
city: Kayseri
country: Turkey
facility: Health Sciences University, Kayseri Medicine Faculty
Study officials:
affiliation: Health Sciences University, Kayseri City Hospital
name: Havva Prof. Dr. TALAY ÇALIŞ
role: PRINCIPAL_INVESTIGATOR
References: