Chondromalacia PatellaeLPPRPNCT06020794
The Efficacy of LPPRP in the Treatment of Chondromalacia Patella
A study testing Exercise and LP-PRP in people with Chondromalacia Patellae, run by Kayseri City Hospital at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Chondromalacia Patellae
- What is being tested?
- Exercise and LP-PRP
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Feb 2021to 4 Nov 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Health Sciences University, Kayseri Medicine Faculty
Kayseri
About this study
Official title: The Efficacy of Leukocyte-poor Platelet Rich Plasma (LPPRP) in the Treatment of Chondromalacia Patella - Randomized Controlled Trial
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.
Read the 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
- Being tested
- Exercise, LP-PRP
- Keywords
- Chondromalacia Patellae, leukocyte-poor platelet-rich plasma, magnetic resonance imaging
- Medical subject headings
- Chondromalacia Patellae
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseBehavioural
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-PRPBiological
The LP-PRPs to be applied will be obtained by centrifugation of the venous blood taken from the patients by manual methods.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Exercise; Biological: LP-PRP |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: at baseline, 1st week, 4th week and 12th week
Secondary outcomes (3)
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.
Measured: at baseline and 12th week
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.
Measured: at baseline and 12th week
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.
Measured: at baseline and 12th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2023
- Study start1 Feb 2021
- Primary completion1 Aug 2022
- Study completion4 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chondromalacia PatellaeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- RANDOMIZED CONTROLLED
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kayseri City Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Havva Talay Calıs, Kayseri City Hospital
- Investigators
- Havva Prof. Dr. TALAY ÇALIŞ, Principal investigator, Kayseri City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06020794
- Sponsor's protocol ID
- KayseriCH
- Acronym
- LPPRP
- Status last verified
- Aug 2023
- First submitted
- 9 Aug 2023
- Last updated
- 1 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Leukocyte-poor Platelet Rich Plasma (LPPRP) in the Treatment of Chondromalacia Patella - Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06020794
- Acronym / sponsor ID
- LPPRP / KayseriCH
- Conditions
- Chondromalacia Patellae
- Keywords
- Chondromalacia Patellae, leukocyte-poor platelet-rich plasma, magnetic resonance imaging
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Kayseri City HospitalOther government
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 1 Aug 2022 (actual)
- Study completion
- 4 Nov 2022 (actual)
- First posted
- 1 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- RANDOMIZED CONTROLLED
| Arm | Type | Receives |
|---|---|---|
| Control Group | Active comparator | Behavioral: ExerciseFirst 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. |
| LP-PRP Group | Active comparator | Behavioral: Exercise, Biological: LP-PRPSecond 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercisequadriceps isometric exercises, straight leg raises, semi-squat exercises, hip flexors, hamstring and iliotibial band stretching exercises, strengthening exercises for hip abductors and adductors | Behavioural | Control Group, LP-PRP Group |
| LP-PRPThe LP-PRPs to be applied will be obtained by centrifugation of the venous blood taken from the patients by manual methods. | Biological | LP-PRP Group |
Primary outcome
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.
3 secondary outcomes
MRI cartilage thickness
Time frame: at baseline and 12th week
MRI defective cartilage thickness
Time frame: at baseline and 12th week
MRI Outerbridge Staging
Time frame: at baseline and 12th week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2023.
Related trials for Chondromalacia Patellae
Not yet recruiting
Sports Rehabilitation Therapy for Knee Joint Sports Injuries: A Case Study of Anterior Cruciate Ligament Injury and Patellar Chondromalacia
Anterior Cruciate Ligament Injury, Patellofemoral Pain Syndrome
RecruitingObservational study
Assessing the Effect of Different Grades of Chondromalacia on Static and Dynamic Balance Using Biodex Balance System
Chondromalacia Patella
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Havva Prof. Dr. TALAY ÇALIŞ principal investigator
Kayseri City Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise and LP-PRP in people with Chondromalacia Patellae, run by Kayseri City Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Western Ontario & McMaster Universities Osteoarthritis Index (WOMAC) (time frame: at baseline, 1st week, 4th week and 12th week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2023.