The use of platelet-leukocyte membrane in arthroscopic repair of large rotator cuff tear
| ISRCTN | ISRCTN93082180 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN93082180 |
| Secondary identifying numbers | N/A |
- 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
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Stefano Gumina
Scientific
Scientific
Via Tacito, 74
Rome
00193
Italy
| s.gumina@tiscali.it |
Study information
| Study design | Prospective randomised controlled study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient 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 | 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 outcome measures | 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 |
| Overall study start date | 19/05/2008 |
| Completion date | 11/10/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 80 consecutive patients |
| 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
Via Tacito, 74
Rome
00193
Italy
00193
Italy
Sponsor information
Orthopaedic Clinic University of Rome "Sapienza" (Italy)
University/education
University/education
c/o Prof Franco Postacchini
Piazzale Aldo Moro, 5
Rome
00185
Italy
"ROR" |
https://ror.org/02be6w209 |
|---|
Funders
Funder type
University/education
Sapienza University of Rome (Italy)
Government organisation / Universities (academic only)
Government organisation / Universities (academic only)
- Alternative name(s)
- Sapienza University of Rome, Università degli Studi di Roma "La Sapienza”, Sapienza-Università di Roma, Sapienza, Uniroma1
- Location
- Italy
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
