The use of platelet-leukocyte membrane in arthroscopic repair of large rotator cuff tear

The use of platelet-leukocyte membrane in arthroscopic repair of large rotator cuff tear: a prospective randomised controlled study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN93082180

Enrollment

Registered

2011-02-28

Start date

2008-05-19

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 tear Musculoskeletal Diseases Shoulder lesions

Interventions

Group I: arthroscopic rotator cuff repair using platelet-leukocyte membrane Group II (control): arthroscopic rotator cuff repair without platelet-leukocyte membrane The total approximate duration of

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Large repairable full-thickness rotator cuff tear 2. Ability of the patient to complete serial MRI examination 3. Aged over 18 years, either sex

Exclusion criteria

Exclusion criteria: 1. A partial thickness 2. Small or massive full-thickness tear 3. Subscapularis tear 4. Severe biceps lesions or biceps instability 5. Labral pathology ameable for surgical repair 6. Os acromiale 7. Degenerative arthritis of the gleno-humeral joint 8. Autoimmune or rheumatological diseases 9. Previous surgery in the same shoulder 10. Worker's compensation claims

Design outcomes

Primary

Measure	Time frame
To evaluate the clinical (Constant score and SST) and MRI results (Sugaya's scale) of single-row arthroscopic rotator cuff repair with and without the employment of platelet-leukocyte membrane in patients with large postero-superior cuff tear. To test the hypothesis that the use of platelet-leukocyte membrane provided superior clinical results in terms of repair integrity, a chi square test was used. Significance level p was set at 0.05	—

Measure

Time frame

To evaluate the clinical (Constant score and SST) and MRI results (Sugaya's scale) of single-row arthroscopic rotator cuff repair with and without the employment of platelet-leukocyte membrane in patients with large postero-superior cuff tear. To test the hypothesis that the use of platelet-leukocyte membrane provided superior clinical results in terms of repair integrity, a chi square test was used. Significance level p was set at 0.05

—

Secondary

Measure	Time frame
Comparison between the two groups. Group I: arthroscopic rotator cuff repair using platelet-leukocyte membrane. Group II (control) arthroscopic rotator cuff repair without platelet-leukocyte membrane	—

Countries

Italy

Outcome results

None listed

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