Trial Outcomes & Findings for PRP vs PRP Plus IGF for Patellar Tendinosis (NCT NCT04350827)
NCT ID: NCT04350827
Last Updated: 2023-10-30
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
14 participants
Primary outcome timeframe
6 months
Results posted on
2023-10-30
Participant Flow
14 participants were consented to participate. All met inclusion/exclusion criteria and were randomized.
Participant milestones
| Measure |
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
|
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
|
|---|---|---|
|
Overall Study
STARTED
|
6
|
8
|
|
Overall Study
6 Months
|
5
|
6
|
|
Overall Study
COMPLETED
|
5
|
6
|
|
Overall Study
NOT COMPLETED
|
1
|
2
|
Reasons for withdrawal
| Measure |
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
|
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
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
2
|
Baseline Characteristics
PRP vs PRP Plus IGF for Patellar Tendinosis
Baseline characteristics by cohort
| Measure |
Platelet Rich Plasma
n=6 Participants
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
|
Platelet Rich Plasma Plus IGF
n=8 Participants
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
|
Total
n=14 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
35 years
STANDARD_DEVIATION 14 • n=5 Participants
|
35 years
STANDARD_DEVIATION 10 • n=7 Participants
|
35 years
STANDARD_DEVIATION 11.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
VISA-P
|
43.6 units on a scale
STANDARD_DEVIATION 18.5 • n=5 Participants
|
45.9 units on a scale
STANDARD_DEVIATION 12.5 • n=7 Participants
|
44.9 units on a scale
STANDARD_DEVIATION 14.8 • n=5 Participants
|
PRIMARY outcome
Timeframe: 6 monthsVictorian 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.
Outcome measures
| Measure |
Platelet Rich Plasma
n=5 Participants
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
|
Platelet Rich Plasma Plus IGF
n=6 Participants
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
|
|---|---|---|
|
Victorian Institute of Sport Assessment-patellar Tendon (VISA-P)
|
66.4 units on a scale
Standard Deviation 17.8
|
78.2 units on a scale
Standard Deviation 15.3
|
SECONDARY outcome
Timeframe: 6 monthsThe 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').
Outcome measures
| Measure |
Platelet Rich Plasma
n=5 Participants
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
|
Platelet Rich Plasma Plus IGF
n=6 Participants
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
|
|---|---|---|
|
Visual Analog Scale-Pain
|
2.38 units on a scale
Standard Deviation 2.82
|
1.30 units on a scale
Standard Deviation 2.07
|
SECONDARY outcome
Timeframe: 6 monthsThe 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.
Outcome measures
| Measure |
Platelet Rich Plasma
n=5 Participants
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
|
Platelet Rich Plasma Plus IGF
n=6 Participants
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
|
|---|---|---|
|
Tegner Activity Scale
|
5.8 units on a scale
Standard Deviation 1.9
|
6.5 units on a scale
Standard Deviation 0.8
|
SECONDARY outcome
Timeframe: 6 monthsClassification 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
Outcome measures
| Measure |
Platelet Rich Plasma
n=5 Participants
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
|
Platelet Rich Plasma Plus IGF
n=6 Participants
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
|
|---|---|---|
|
Blazina Classification
Stage 1
|
4 Participants
|
5 Participants
|
|
Blazina Classification
Stage 2
|
0 Participants
|
1 Participants
|
|
Blazina Classification
Stage 3
|
1 Participants
|
0 Participants
|
|
Blazina Classification
Stage 4
|
0 Participants
|
0 Participants
|
Adverse Events
Platelet Rich Plasma
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Platelet Rich Plasma Plus IGF
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place