Satety and Effects of Placentex Injection in Patient with Partial Tear of Rotator Cuff Tendon: An Open Label Study

Safety and Effect of Placentex Injection in Patient with Partial Tear of Rotator Cuff Tendon: An Open Label Study

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CRIS

Registry ID

KCT0000767

Enrollment

Registered

2013-06-13

Start date

2013-06-25

Completion date

Unknown

Last updated

2019-03-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Drug, Procedure/Surgery : Treatment of partial rotator cuff tear with PDRN injection at tear site

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: 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).

Design outcomes

Primary

Measure	Time frame
Shoulder pain by VAS;Disabilities of arm, hand, shoulder by DASH	—

Secondary

Measure	Time frame
Range of motion;Strength of shoulder girdle;Tear size measured by US	—

Countries

Korea, Republic of

Contacts

Public Contactboram Kim

Seoul National University Bundang Hospital

Outcome results