Patellar Ligament, Platelet-Rich Plasma, Tendinopathy
Conditions
Brief summary
The purpose of this study is to compare two different platelet-rich plasma (PRP) injections for patellar tendinosis. Aim: To perform a randomized, double blinded study comparing the clinical effect of PRP versus PRP + concentrated insulin-like growth factor (IGF) in patients with patellar tendinosis.
Detailed description
Introduction/Background: Patellar tendinosis is a frustrating ailment commonly encountered in sports medicine. Treating this condition continues to be a significant challenge for sports medicine physicians. The tendinosis lesion is characterized by collagen disorganization and increased ground substance. One method of treating this problem is using platelet rich plasma (PRP), which is a concentration of platelets from the patient's own blood that provides a high dose of growth factors aimed at stimulating tendon healing. These injections have been used extensively to treat many tendon disorders including patellar tendinosis. Several studies have demonstrated the safety and efficacy of using PRP to treat patellar tendinosis. One growth factor that is known to be helpful in tendon healing is insulin-like growth factor (IGF). However, IGF is not found in PRP but rather in the free plasma that is spun off during the PRP processing. This free plasma or platelet poor plasma (PPP) is typically discarded but it is a known source of IGF. We have shown that concentrating PPP in the FDA cleared Plasmax device yields an increased concentration of insulin-like growth factor (IGF). Local IGF injections into the patellar tendon have demonstrated improved tendon healing, but the effect on clinical outcomes has never been studied in a controlled fashion. Research Design: Double blinded randomized comparative trial. Detailed Study Procedures: 38 patients will be randomly assigned to a treatment arm. 19 patients will receive platelet rich plasma (PRP) and 19 patients will receive PRP plus concentrated IGF. Patient will be blinded to their treatment, but treatment team will not. PRP will be prepared according to standard sterile procedures out of view of the patient to ensure patients are adequately blinded. The injecting physician will not be blinded to randomization scheme.
Interventions
DEVICEPlatelet Rich Plasma
Platelet rich plasma injection into patellar tendon
DEVICEPlatelet Rich Plasma plus IGF
Platelet rich plasma plus IGF injection into patellar tendon
Sponsors
Ohio State University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Intervention model description
Double blinded randomized comparative trial.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* \>6 weeks of symptomatic patellar tendinosis * unilateral or bilateral * 18 yrs of age or older * active in sport and exercise at least 3x / week * able to take time away from sport (for healing and rehabilitation phase after procedure) * failed at least 6 weeks of guided rehabilitation (under the supervision of either a certified athletic trainer or physical therapist) * minimum Tegner activity level of 4
Exclusion criteria
* Steroid injection in target knee in the last 3 months * PRP in the target knee in the last 6 months * No other cellular treatments in index knee (bone marrow, amniotic suspensions) last 1 year * Participation in any experimental device or drug study within 1 year before screening visit * Oral or IM steroids for last 3 months * Dry needling of patellar tendon in last 6 months
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Victorian Institute of Sport Assessment-patellar Tendon (VISA-P) | 6 months | Victorian Institute of sport assessment scale for patellar tendinopathy \[VISA-P\] is a self-administered questionnaire consisting of 8 items; 6 are used to evaluate pain levels or disability in daily activities and specific functional tests and 2 provide information regarding ability to play sport. The maximum score possible is 100 points and represents an asymptomatic athlete who can fully engage in sports. The theoretical minimum is 0 points. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Visual Analog Scale-Pain | 6 months | The Visual Analog Scale (VAS) measures pain intensity. The VAS consists of a 10cm line, with two end points representing 0 ('no pain') and 10 ('pain as bad as it could possibly be'). |
| Tegner Activity Scale | 6 months | The Tegner activity scale is a one-item score that grads activity based on work and sports activities on a scale of 0 to 10. Zero represents disability because of knee problems and 10 athlete participating in competitive sports. |
| Blazina Classification | 6 months | Classification scale for functional limitations associated with patellar tendinitis. Stage 1: Pain after sports activity, Stage 2: Pain at the beginning of sports activity, disappearing with warm-up and sometimes reappearing with fatigue, Stage 3: Pain at rest and during activity; inability to participate in sports, Stage 4: Rupture of the patellar tendon |
Countries
United States
Participant flow
Recruitment details
14 participants were consented to participate. All met inclusion/exclusion criteria and were randomized.
Participants by arm
| Arm | Count |
|---|---|
| Platelet Rich Plasma Procedure will be carried out with excellent sterile technique. 54ml of whole blood will be drawn. 54ml will be processed by centrifugation using the GPS III system (Zimmer Biomet, Warsaw, IN) and 1 ml will undergo a complete blood count (for a baseline comparison to determine the fold increase in platelets). The resultant PRP (5ml) will be injected (after 5ml 1% lidocaine has been injected into the skin for comfort) into the patellar tendon using ultrasound guidance to accurately direct the injection to the site of the tendon abnormality. The patient will rest after the injection for 15 minutes and then be dismissed.
Platelet Rich Plasma: Platelet rich plasma injection into patellar tendon | 6 |
| Platelet Rich Plasma Plus IGF The PRP preparation and blood draw will be identical to the above. 55ml of whole blood will be drawn (1ml will undergo a CBC and the remaining 54ml will be used to make PRP). In addition to preparing the PRP, the resultant PPP (instead of discarding it) will be placed into the Plasmax device (Zimmer Biomet, Warsaw, IN) and concentrated via a second centrifugation cycle. The plasmax concentrate (concentrated IGF) will be added to the PRP (3ml of PRP + 2ml of plasmax concentrate for a total of 5ml) and then will be injected (after 5ml 1% lidocaine has been injected into the skin for comfort) under ultrasound guidance followed by the same rest period.
Platelet Rich Plasma plus IGF: Platelet rich plasma plus IGF injection into patellar tendon | 8 |
| Total | 14 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 1 | 2 |
Baseline characteristics
| Characteristic | Platelet Rich Plasma | Total | Platelet Rich Plasma Plus IGF |
|---|---|---|---|
| Age, Continuous | 35 years STANDARD_DEVIATION 14 | 35 years STANDARD_DEVIATION 11.6 | 35 years STANDARD_DEVIATION 10 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 6 Participants | 13 Participants | 7 Participants |
| Sex: Female, Male Female | 1 Participants | 4 Participants | 3 Participants |
| Sex: Female, Male Male | 5 Participants | 10 Participants | 5 Participants |
| VISA-P | 43.6 units on a scale STANDARD_DEVIATION 18.5 | 44.9 units on a scale STANDARD_DEVIATION 14.8 | 45.9 units on a scale STANDARD_DEVIATION 12.5 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 5 | 0 / 6 |
| other Total, other adverse events | 0 / 5 | 0 / 6 |
| serious Total, serious adverse events | 0 / 5 | 0 / 6 |
Outcome results
Primary
Victorian Institute of Sport Assessment-patellar Tendon (VISA-P)
Victorian Institute of sport assessment scale for patellar tendinopathy \[VISA-P\] is a self-administered questionnaire consisting of 8 items; 6 are used to evaluate pain levels or disability in daily activities and specific functional tests and 2 provide information regarding ability to play sport. The maximum score possible is 100 points and represents an asymptomatic athlete who can fully engage in sports. The theoretical minimum is 0 points.
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Platelet Rich Plasma | Victorian Institute of Sport Assessment-patellar Tendon (VISA-P) | 66.4 units on a scale | Standard Deviation 17.8 |
| Platelet Rich Plasma Plus IGF | Victorian Institute of Sport Assessment-patellar Tendon (VISA-P) | 78.2 units on a scale | Standard Deviation 15.3 |
p-value: 0.433ANOVA
Secondary
Blazina Classification
Classification scale for functional limitations associated with patellar tendinitis. Stage 1: Pain after sports activity, Stage 2: Pain at the beginning of sports activity, disappearing with warm-up and sometimes reappearing with fatigue, Stage 3: Pain at rest and during activity; inability to participate in sports, Stage 4: Rupture of the patellar tendon
Time frame: 6 months
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Platelet Rich Plasma | Blazina Classification | Stage 1 | 4 Participants |
| Platelet Rich Plasma | Blazina Classification | Stage 2 | 0 Participants |
| Platelet Rich Plasma | Blazina Classification | Stage 3 | 1 Participants |
| Platelet Rich Plasma | Blazina Classification | Stage 4 | 0 Participants |
| Platelet Rich Plasma Plus IGF | Blazina Classification | Stage 4 | 0 Participants |
| Platelet Rich Plasma Plus IGF | Blazina Classification | Stage 1 | 5 Participants |
| Platelet Rich Plasma Plus IGF | Blazina Classification | Stage 3 | 0 Participants |
| Platelet Rich Plasma Plus IGF | Blazina Classification | Stage 2 | 1 Participants |
Secondary
Tegner Activity Scale
The Tegner activity scale is a one-item score that grads activity based on work and sports activities on a scale of 0 to 10. Zero represents disability because of knee problems and 10 athlete participating in competitive sports.
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Platelet Rich Plasma | Tegner Activity Scale | 5.8 units on a scale | Standard Deviation 1.9 |
| Platelet Rich Plasma Plus IGF | Tegner Activity Scale | 6.5 units on a scale | Standard Deviation 0.8 |
Secondary
Visual Analog Scale-Pain
The Visual Analog Scale (VAS) measures pain intensity. The VAS consists of a 10cm line, with two end points representing 0 ('no pain') and 10 ('pain as bad as it could possibly be').
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Platelet Rich Plasma | Visual Analog Scale-Pain | 2.38 units on a scale | Standard Deviation 2.82 |
| Platelet Rich Plasma Plus IGF | Visual Analog Scale-Pain | 1.30 units on a scale | Standard Deviation 2.07 |