The Efficacy of LPPRP in the Treatment of Chondromalacia Patella

NCT06020794 | Completed

• 1 other identifier: KayseriCH
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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.

Conditions

Chondromalacia Patellae

Keywords

Chondromalacia Patellae; leukocyte-poor platelet-rich plasma; magnetic resonance imaging

Outcome Measures

Primary Outcomes (1)

• 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.

  at baseline, 1st week, 4th week and 12th week

Secondary Outcomes (3)

• MRI cartilage thickness

  at baseline and 12th week

• MRI defective cartilage thickness

  at baseline and 12th week

• MRI Outerbridge Staging

  at baseline and 12th week

Other Outcomes (2)

• Visual analog scale (VAS)

  at baseline, 1st week, 4th week and 12th week

• Six minute walk test

  at baseline, 1st week, 4th week and 12th week

Study Arms (2)

Control Group

ACTIVE COMPARATOR

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.

Behavioral: Exercise

LP-PRP Group

ACTIVE COMPARATOR

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.

Behavioral: Exercise; Biological: LP-PRP

Interventions

Exercise 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

Control Group; LP-PRP Group

LP-PRP BIOLOGICAL

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

LP-PRP Group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kayseri City Hospital: lead

Study Sites (1)

Health Sciences University, Kayseri Medicine Faculty

Kayseri, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Chondromalacia Patellae

Interventions

Exercise

Condition Hierarchy (Ancestors)

Cartilage Diseases; Musculoskeletal Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Havva Prof. Dr. TALAY ÇALIŞ

  Health Sciences University, Kayseri City Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr.

Model Details: RANDOMIZED CONTROLLED

Study Record Dates

• First Submitted: August 9, 2023
• First Posted: September 1, 2023
• Study Start: February 1, 2021
• Primary Completion: August 1, 2022
• Study Completion: November 4, 2022
• Last Updated: September 1, 2023

Record last verified: 2023-08

Locations

TU (1)