Growth factors augmentation for arthroscopic rotator cuff repair

Efficacy and safety of growth factors augmentation for arthroscopic rotator cuff repair compared with non-augmented repair: a randomised controlled trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN49643328

Enrollment

Registered

2010-02-02

Start date

2007-01-03

Completion date

Unknown

Last updated

2015-01-13

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

Conditions

Rotator-cuff tendon tear Injury, Occupational Diseases, Poisoning Injury of muscle and tendon at shoulder and upper arm level

Interventions

Study group: Arthroscopic rotator cuff repair and augmentation with platelet-rich fibrin matrix (Cascade® Autologous Platelet System, Musculoskeletal Transplant Foundation [MTF]). Control group: Ar

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Aged over 30 years, either sex 2. Rotator cuff tear diagnosed on clinical grounds 3. No episodes of shoulder instability 4. No radiographic signs of fracture of the glenoid or the greater or lesser tuberosity 5. Magnetic resonance imaging evidence of cuff tear 6. A repairable full-thickness tear of the rotator cuff found at the time of surgery 7. Patients with associated biceps pathology are also included

Exclusion criteria

Exclusion criteria: 1. Inflammatory joint disease 2. Irreparable full-thickness tear or partial thickness tear of the rotator cuff found at the time of surgery 3. Symptomatic arthritis of the acromioclavicular joint 4. Rotator cuff arthropathy 5. Pathologies of the subscapularis tendon 6. Workers' Compensation claims 7. Prior surgery on the affected shoulder 8. Inability to complete questionnaires because of language problem

Design outcomes

Primary

Measure	Time frame
Difference in change from baseline to 16 months in the Constant Score between the two groups. The Constant Score is a scoring system shoulder rating scale evaluating shoulder pain (15 points), activities of daily living (20 points), range of movement (40 points), and power (25 points). Total possible score is 100 points, indicating an asymptomatic and healthy person, while the worst score is 0 points.	—

Measure

Time frame

Difference in change from baseline to 16 months in the Constant Score between the two groups. The Constant Score is a scoring system shoulder rating scale evaluating shoulder pain (15 points), activities of daily living (20 points), range of movement (40 points), and power (25 points). Total possible score is 100 points, indicating an asymptomatic and healthy person, while the worst score is 0 points.

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Secondary

Measure	Time frame
Integrity of the repaired rotator cuff, as evaluated by MRI.	—

Countries

Italy

Outcome results

None listed

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