Trial Outcomes & Findings for Non-Surgical Treatment for Rotator-Cuff Tears Using Platelet-Rich-Plasma (NCT NCT02246530)
NCT ID: NCT02246530
Last Updated: 2022-05-16
Results Overview
Comparing baseline diagnostic ultrasound for structural changes. An initial diagnostic ultrasound image was obtained to demonstrate a tear of the supraspinatus tendon, a key tendon of the rotator cuff. Once a tear of this tendon was confirmed, patient were delegated to one of the study arms and proceeded to the injection phase of the study. Two subject's data (within the PRP group) is incomplete as these subjects were lost to follow up and do not have completed 6 month follow up ultrasound imaging to review.
TERMINATED
NA
11 participants
6 months post procedure
2022-05-16
Participant Flow
Subjects were recruited from an outpatient Physical Medicine and Rehabilitation clinic at the University of Alabama. Each subject was given information regarding the study requirements and follow up obligations prior to enrollment and signed to complete based on their confidentiality agreement form.
Three subjects in this study were enrolled however prior to randomization in to their respective groups, they had a negative diagnostic ultrasound thus they were excluded from the study.
Participant milestones
| Measure |
PRP Injection Into PTRCT
Treatment - PRP injection
PRP injection into PTRCT: Day of procedure, 60 cc blood draw will be taken for processing and isolation of PRP. PRP sample will be injected peri-tendinous / intra-tendinous area at location of the PTRCT under ultrasound guidance to ensure accurate placement at site of injury.
PRP is an autologous blood product that is being re-injected into the same patient and is considered a non-invasive interventional procedure. PRP is classified as a procedure and not a drug.
|
Subacromial Steroid Bursal Injection
Current standard of care for treatment of resistant partial thickness rotator cuff tears
Subacromial steroid bursal injection: Combination steroid (Celestone) and anesthetic drug (Lidocaine) will be injected into the patient's subacromial bursa via needle guidance of ultrasound
|
|---|---|---|
|
Overall Study
STARTED
|
9
|
2
|
|
Overall Study
COMPLETED
|
5
|
2
|
|
Overall Study
NOT COMPLETED
|
4
|
0
|
Reasons for withdrawal
| Measure |
PRP Injection Into PTRCT
Treatment - PRP injection
PRP injection into PTRCT: Day of procedure, 60 cc blood draw will be taken for processing and isolation of PRP. PRP sample will be injected peri-tendinous / intra-tendinous area at location of the PTRCT under ultrasound guidance to ensure accurate placement at site of injury.
PRP is an autologous blood product that is being re-injected into the same patient and is considered a non-invasive interventional procedure. PRP is classified as a procedure and not a drug.
|
Subacromial Steroid Bursal Injection
Current standard of care for treatment of resistant partial thickness rotator cuff tears
Subacromial steroid bursal injection: Combination steroid (Celestone) and anesthetic drug (Lidocaine) will be injected into the patient's subacromial bursa via needle guidance of ultrasound
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
4
|
0
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
PRP Injection Into PTRCT
n=5 Participants
Treatment - PRP injection
PRP injection into PTRCT: Day of procedure, 60 cc blood draw will be taken for processing and isolation of PRP. PRP sample will be injected peri-tendinous / intra-tendinous area at location of the PTRCT under ultrasound guidance to ensure accurate placement at site of injury.
PRP is an autologous blood product that is being re-injected into the same patient and is considered a non-invasive interventional procedure. PRP is classified as a procedure and not a drug.
|
Subacromial Steroid Bursal Injection
n=2 Participants
Current standard of care for treatment of resistant partial thickness rotator cuff tears
Subacromial steroid bursal injection: Combination steroid (Celestone) and anesthetic drug (Lidocaine) will be injected into the patient's subacromial bursa via needle guidance of ultrasound
|
Total
n=7 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=7 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
5 Participants
n=5 Participants
|
2 Participants
n=2 Participants
|
7 Participants
n=7 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=7 Participants
|
|
Age, Continuous
|
48.13 Years
n=5 Participants
|
57.5 Years
n=2 Participants
|
50 Years
n=7 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
1 Participants
n=2 Participants
|
4 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
1 Participants
n=2 Participants
|
3 Participants
n=7 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
5 participants
n=5 Participants
|
2 participants
n=2 Participants
|
11 participants
n=7 Participants
|
|
SPADI (Shoulder Pain and Disability Index) Score
|
43.69 SPADI Score
n=5 Participants
|
23.08 SPADI Score
n=2 Participants
|
37.80 SPADI Score
n=7 Participants
|
PRIMARY outcome
Timeframe: 6 months post procedureComparing baseline diagnostic ultrasound for structural changes. An initial diagnostic ultrasound image was obtained to demonstrate a tear of the supraspinatus tendon, a key tendon of the rotator cuff. Once a tear of this tendon was confirmed, patient were delegated to one of the study arms and proceeded to the injection phase of the study. Two subject's data (within the PRP group) is incomplete as these subjects were lost to follow up and do not have completed 6 month follow up ultrasound imaging to review.
Outcome measures
| Measure |
PRP Injection Into PTRCT
n=5 Participants
Treatment - PRP injection
PRP injection into PTRCT: Day of procedure, 60 cc blood draw will be taken for processing and isolation of PRP. PRP sample will be injected peri-tendinous / intra-tendinous area at location of the PTRCT under ultrasound guidance to ensure accurate placement at site of injury.
PRP is an autologous blood product that is being re-injected into the same patient and is considered a non-invasive interventional procedure. PRP is classified as a procedure and not a drug.
|
Subacromial Steroid Bursal Injection
n=2 Participants
Current standard of care for treatment of resistant partial thickness rotator cuff tears
Subacromial steroid bursal injection: Combination steroid (Celestone) and anesthetic drug (Lidocaine) will be injected into the patient's subacromial bursa via needle guidance of ultrasound
|
|---|---|---|
|
Diagnostic Ultrasound
Number with improved (smaller) tear at follow up
|
2 Participants
|
0 Participants
|
|
Diagnostic Ultrasound
Number with resolved tear at follow up
|
2 Participants
|
2 Participants
|
|
Diagnostic Ultrasound
Incomplete data (lost to follow up)
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Week 3 post procedure SPADI Scores for the control and treatment groups.Comparing the questionnaire Shoulder Pain and Disability Index (SPADI) Scores to assess improvement after intervention. The SPADI is a self-administered questionnaire that addressed pain and disability in functional activities. The raw score ranges from 0 (no pain or disability) to 130 (highest pain in each pain category and highest difficulty in each functional category). The SPADI Score is then calculated as a percentage (raw score / 130). Thus, the final score is a range of 0% to 100%. In the PRP (platelet rich plasma injection) group we had 5 participants completed the study. 2 participants in the control (corticosteroid injection) group completed the study.
Outcome measures
| Measure |
PRP Injection Into PTRCT
n=5 Participants
Treatment - PRP injection
PRP injection into PTRCT: Day of procedure, 60 cc blood draw will be taken for processing and isolation of PRP. PRP sample will be injected peri-tendinous / intra-tendinous area at location of the PTRCT under ultrasound guidance to ensure accurate placement at site of injury.
PRP is an autologous blood product that is being re-injected into the same patient and is considered a non-invasive interventional procedure. PRP is classified as a procedure and not a drug.
|
Subacromial Steroid Bursal Injection
n=2 Participants
Current standard of care for treatment of resistant partial thickness rotator cuff tears
Subacromial steroid bursal injection: Combination steroid (Celestone) and anesthetic drug (Lidocaine) will be injected into the patient's subacromial bursa via needle guidance of ultrasound
|
|---|---|---|
|
Shoulder Pain and Disability Index
|
16.00 scores on a scale
Interval 2.31 to 54.62
|
18.08 scores on a scale
Interval 17.69 to 18.46
|
SECONDARY outcome
Timeframe: Week 6 post procedure SPADI Scores for the treatment and control groups.Comparing the questionnaire Shoulder Pain and Disability Index (SPADI) Scores to assess improvement after intervention. The SPADI is a self-administered questionnaire that addressed pain and disability in functional activities. The raw score ranges from 0 (no pain or disability) to 130 (highest pain in each pain category and highest difficulty in each functional category). The SPADI Score is then calculated as a percentage (raw score / 130). Thus, the final score is a range of 0% to 100%. In the PRP (platelet rich plasma injection) group we had 5 participants completed the study. 2 participants in the control (corticosteroid injection) group completed the study.
Outcome measures
| Measure |
PRP Injection Into PTRCT
n=5 Participants
Treatment - PRP injection
PRP injection into PTRCT: Day of procedure, 60 cc blood draw will be taken for processing and isolation of PRP. PRP sample will be injected peri-tendinous / intra-tendinous area at location of the PTRCT under ultrasound guidance to ensure accurate placement at site of injury.
PRP is an autologous blood product that is being re-injected into the same patient and is considered a non-invasive interventional procedure. PRP is classified as a procedure and not a drug.
|
Subacromial Steroid Bursal Injection
n=2 Participants
Current standard of care for treatment of resistant partial thickness rotator cuff tears
Subacromial steroid bursal injection: Combination steroid (Celestone) and anesthetic drug (Lidocaine) will be injected into the patient's subacromial bursa via needle guidance of ultrasound
|
|---|---|---|
|
Shoulder Pain and Disability Index
|
8.00 scores on a scale
Interval 0.0 to 24.62
|
18.46 scores on a scale
Interval 15.38 to 21.54
|
SECONDARY outcome
Timeframe: 6 months post procedure SPADI scores for the treatment and control groups.Comparing the questionnaire Shoulder Pain and Disability Index (SPADI) Scores to assess improvement after intervention. The SPADI is a self-administered questionnaire that addressed pain and disability in functional activities. The raw score ranges from 0 (no pain or disability) to 130 (highest pain in each pain category and highest difficulty in each functional category). The SPADI Score is then calculated as a percentage (raw score / 130). Thus, the final score is a range of 0% to 100%. In the PRP (platelet rich plasma injection) group we had 5 participants completed the study. 2 participants in the control (corticosteroid injection) group completed the study.
Outcome measures
| Measure |
PRP Injection Into PTRCT
n=5 Participants
Treatment - PRP injection
PRP injection into PTRCT: Day of procedure, 60 cc blood draw will be taken for processing and isolation of PRP. PRP sample will be injected peri-tendinous / intra-tendinous area at location of the PTRCT under ultrasound guidance to ensure accurate placement at site of injury.
PRP is an autologous blood product that is being re-injected into the same patient and is considered a non-invasive interventional procedure. PRP is classified as a procedure and not a drug.
|
Subacromial Steroid Bursal Injection
n=2 Participants
Current standard of care for treatment of resistant partial thickness rotator cuff tears
Subacromial steroid bursal injection: Combination steroid (Celestone) and anesthetic drug (Lidocaine) will be injected into the patient's subacromial bursa via needle guidance of ultrasound
|
|---|---|---|
|
Shoulder Pain and Disability Index
|
3.08 scores on a scale
Interval 0.0 to 4.62
|
7.31 scores on a scale
Interval 3.08 to 11.54
|
Adverse Events
PRP Injection Into PTRCT
Subacromial Steroid Bursal Injection
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Breanna Willeford, DO
University of Alabama at Birmingham
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place