The Efficacy of LPPRP in the Treatment of Chondromalacia Patella

NCT ID: NCT06020794

Last Updated: 2023-09-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-02-01
• Study Completion Date: 2022-11-04

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

Conditions

Chondromalacia Patellae

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Exercise

Intervention Type: BEHAVIORAL

quadriceps isometric exercises, straight leg raises, semi-squat exercises, hip flexors, hamstring and iliotibial band stretching exercises, strengthening exercises for hip abductors and adductors

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.

Group Type: ACTIVE_COMPARATOR

Exercise

Intervention Type: BEHAVIORAL

quadriceps isometric exercises, straight leg raises, semi-squat exercises, hip flexors, hamstring and iliotibial band stretching exercises, strengthening exercises for hip abductors and adductors

LP-PRP

Intervention Type: BIOLOGICAL

The LP-PRPs to be applied will be obtained by centrifugation of the venous blood taken from the patients by manual methods.

Interventions

Exercise

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: BEHAVIORAL

LP-PRP

The LP-PRPs to be applied will be obtained by centrifugation of the venous blood taken from the patients by manual methods.

Intervention Type: BIOLOGICAL

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kayseri City Hospital

OTHER_GOV

Sponsor Role: lead

Responsible Party

Havva Talay Calıs

Prof. Dr.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Havva Prof. Dr. TALAY ÇALIŞ

Role: PRINCIPAL_INVESTIGATOR

Health Sciences University, Kayseri City Hospital

Locations

Health Sciences University, Kayseri Medicine Faculty

Kayseri, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

KayseriCH

Identifier Type: -

Identifier Source: org_study_id