The use of platelet-leukocyte membrane in arthroscopic repair of large rotator cuff tear
| ISRCTN | ISRCTN93082180 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN93082180 |
| Protocol serial number | N/A |
| Sponsor | Orthopaedic Clinic University of Rome "Sapienza" (Italy) |
| Funder | Sapienza University of Rome (Italy) |
- Submission date
- 16/12/2010
- Registration date
- 28/02/2011
- Last edited
- 28/02/2011
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Plain English summary of protocol
Not provided at time of registration
Contact information
Scientific
Via Tacito, 74
Rome
00193
Italy
| s.gumina@tiscali.it |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Prospective randomised controlled study |
| Secondary study design | Non randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | The use of platelet-leukocyte membrane in arthroscopic repair of large rotator cuff tear: a prospective randomised controlled study |
| Study objectives | The purpose of this study was to evaluate the clinical and magnetic resonance imaging (MRI) results of single-row arthroscopic rotator cuff repair with and without the employment of platelet-leukocyte membrane in patients with large postero-superior cuff tear. |
| Ethics approval(s) | Ethics Board of the University of Rome "Sapienza" and Policlinico Umberto I approved in 2008 (ref: 2/08) |
| Health condition(s) or problem(s) studied | Rotator cuff tear |
| Intervention | 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 treatment was 18 months, considering first clinical exam/diagnosis, operation, follow up at 3 and 6 months and final follow-up with clinical exam and MRI of the involved shoulder. |
| Intervention type | Other |
| Primary outcome measure(s) |
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 |
| Key secondary outcome measure(s) |
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 |
| Completion date | 11/10/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 80 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 19/05/2008 |
| Date of final enrolment | 11/10/2010 |
Locations
Countries of recruitment
- Italy
Study participating centre
00193
Italy
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
