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Improvement of partial rotator cuff tears with the use of human platelet lysate

Effectiveness of Using Human Platelet Lysate (hPL) to Treat Supraspinatus Tendinopathy - Clinical Trial

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN17311049
Enrollment
30
Registered
2020-01-28
Start date
2020-02-01
Completion date
Unknown
Last updated
2020-02-24

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

Conditions

Supraspinatus tendinopathies Musculoskeletal Diseases

Interventions

All patients will be subjected to the collection of a blood sample to quantify platelets, and thus, ensure that they are in accordance with the proposed inclusion criteria. The sample will be fraction

Sponsors

Hospital São Paulo
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Over 40 years old 2. Pain in the anterolateral shoulder region, without irradiation to the forearm region 3. Pain for more than 3 months of symptoms (measured by Visual Analog Scale) 4. Physical examination (positive Neer test, associated with the Hawkins Kennedy Test and the positive Jobe test) plus magnetic resonance imaging compatible with supraspinatus tendinopathy or partial lesion less than 50%, evaluated by 3 independent evaluators (two orthopedists and a radiologist) 5. Submit and accept the term of clarification and free consent 6. Have not undergone surgery or local injection in the shoulder 7. Agree and sign the free and informed consent form

Exclusion criteria

Exclusion criteria: 1. Bilateral supraspinatus tendon lesions 2. Presence of fractures, surgeries, infiltrations or previous injuries to the affected shoulder 3. Any condition that is a contraindication to interventions 4. Restriction of passive shoulder range of motion on physical examination 5. Signs of other associated diseases on MRI, except acromioclavicular degeneration 6. Platelets of less than 50,000 7. Contraindication to use any component of the proposed treatments

Design outcomes

Primary

MeasureTime frame
Pain measured using the visual analog scale at baseline and 1, 2, 4, 8, 12 weeks and 6 months after the procedure

Secondary

MeasureTime frame
At baseline and 1, 2, 4, 8, 12 weeks and 6 months after the procedure: 1. Shoulder function measured using the Shoulder Pain and Diability Index (SPADI), Neer and Hawkins test, and Quick-Dash 2. The range of motion with digital goniometer (flexion, lateral rotation and medial rotation) 3. Shoulder ultrasound examination (evaluation of tendinopathy size and lesion in millimeters) 4. Complications and adverse effects (according to severity and date of occurrence) measured using patient records

Countries

Brazil

Contacts

Public ContactLauro Pajolli
lpajolli@huhsp.org.br+55 1155797049

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026