Satety and Effects of Placentex Injection in Patient with Partial Tear of Rotator Cuff Tendon: An Open Label Study
- Conditions
- Diseases of the musculo-skeletal system and connective tissue
- Registration Number
- KCT0000767
- Lead Sponsor
- Seoul National University Bundang Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 15
1)Who is not included in exclusion criteria of enrolling
2)Who agree with a consent form after being explaned about the purpose and content of the treatment.
3)Who is over 18 years old.
4)Who has partial rotator cuff tear which is diagnosed with physical examination, simple x-ray, and sonographic test.
5)The size partial rotator cuff tear is less than half of total depth, less than 1 cm in length.
6)Do not respond to conservative management.
7)Who does not have allergic reaction.
8)Who does not suffer from psychologic disorder.
1)Who disagree with this clinical test.
2)Who has history of alcohol or opioid addiction.
3)Who is having treatment of infectious disease.
4)Who had a steroid or other injection management in 6 weeks.
5)Who has arthritis, rheumatoid arthritis, synovitis, nerve entrapment, radiculopathy, septic arthritis, paralysis.
6)Who has medical emergency, hemorrhagic disorder, contraindication to local injection.
7)Who is pregnant or state of breast feeding.
8)Who is malnutrient.
9)Who has psychologic disorder.
10)Who has hypotension of which blood pressure is less than 100 mmHg in systole and 60 mmHg in diastole.
11)Who has liver or renal disease.
12)Who is managed with vasoconstrictor.
13)Who has severe medical disease such as diabetes or hepatitis.
14)Who had medication for other clinical test in 3 months.
15)Who is considered inappropriate other than above causes by test manager.
16)Who has allergic reaction to this drug(PDRN).
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Shoulder pain by VAS;Disabilities of arm, hand, shoulder by DASH
- Secondary Outcome Measures
Name Time Method Range of motion;Strength of shoulder girdle;Tear size measured by US