Clinical trial NCT03986372: The Effect of Multiple Injection of Platlet-rich Plasma in Chronic Patellar Tendinopathy
Official title: The Effect of Multiple Injection of Platlet-rich Plasma in Chronic Patellar Tendinopathy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Tendinopathy
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2019-06-14
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: According to previous studies, the effect of PRP to patellar tendinopathy could last longer. However, the type, concentration, time and frequent of injection are still debated。 This study is to understand the effect of multiple injection of platlet-rich plasma in chronic patellar tendinopathy and to analyze the relation between efficacy of PRP and the growth factor in PRP.

Detailed description: Patellar tendinopathy, also known as jumper's knee，is clinically common characterised by anterior knee pain, activity-related pain、local tenderness over inferior pole of patella. The discomfort can result in decreasing athletic performance and be one of the most challenge for sports medicine doctor.

The patellar tendon suffer from repetitive microtrauma，result in reactive patellar tendinopathy. The overload tendon combining with risk factors of patellar tendinopathy will not recover timely and progress to chronic patellar tendinopathy. Hence, to reverse the progression is our aim.

According to previous studies, several nonsurgical treatment options have been proposed such as medication, eccentric exercise, corticosteroid injection, shockwave and platelet-rich plasma (PRP). Among all the options, the effect of PRP could last longer. However, the type, concentration, time and frequent of injection are still debated。Moreover, there is no study about the relationship between efficacy and the ratio and concentration of growth factor in the PRP.

The aim of this study is to understand (1) The effect of multiple injection of platlet-rich plasma in chronic patellar tendinopathy. (2) The effect of leukocyte-rich PRP in chronic patellar tendinopathy (3) Analyze the relation between efficacy of PRP and the growth factor in PRP.

Eligibility criteria: Inclusion Criteria:

Chronic patellar tendinopathy

Exclusion Criteria:

1. Corticosteroid injections within 12 months
2. Previous knee surgery
3. Any confounding diagnosis to the knee joint
4. Arthritis
5. Rheumatoid arthritis
6. Diabetes
7. Infections of knee joint
8. NSAIDs in the 10 days before the procedure

Primary outcomes:
measure: Change from baseline Victorian Institute of Sport Assessment (VISA-P) score to 36 weeks
timeFrame: 36 weeks
measure: Change from baseline modified Blazina Scale to 36 weeks
timeFrame: 36 weeks
measure: Change from baseline thickness of patellar tendon to 36 weeks
timeFrame: 36 weeks
measure: Change from baseline Visual analogue score(VAS) to 36 weeks
timeFrame: 36 weeks
Secondary outcomes:
measure: Correlation between Platlet derived growth factor (PDGF) and VISA-P score
timeFrame: 36 weeks
measure: Correlation between Transforming growth factor beta 1 (TGF beta 1) and VISA-P score
timeFrame: 36 weeks
measure: Correlation between Epithelial growth factor (EGF) and VISA-P score
timeFrame: 36 weeks
measure: Change from baseline Victorian Institute of Sport Assessment (VISA) score to 104 weeks
timeFrame: 104 weeks
Other outcomes:
Locations:
city: Taoyuan
country: Taiwan
facility: Taoyuan Chang Gung Memorial Hospital
Study officials:
References: