Growth factors augmentation for arthroscopic rotator cuff repair
| ISRCTN | ISRCTN49643328 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN49643328 |
| Secondary identifying numbers | N/A |
- Submission date
- 06/01/2010
- Registration date
- 02/02/2010
- Last edited
- 02/02/2010
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Injury, Occupational Diseases, Poisoning
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
Dr Roberto Castricini
Scientific
Scientific
Asur marche
Ospedale di Jesi
U. O. Di ortopedia e traumatologia
Jesi
60010
Italy
Study information
| Study design | Interventional randomised single centre single-blind placebo-controlled cross-over study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | 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 | Efficacy and safety of growth factors augmentation for arthroscopic rotator cuff repair compared with non-augmented repair: a randomised controlled trial |
| Study objectives | To test the hypothesis that growth factors augmentation results in increased improvement in shoulder function and better magnetic resonance imaging (MRI) appearance in patients undergoing arthroscopic repair of small or moderate rotator cuff tears. |
| Ethics approval(s) | Local ethics committee (Comitato etico dellOspedale di Iesi, ASUR MARCHE) approved on the 2nd January 2007 |
| Health condition(s) or problem(s) studied | Rotator-cuff tendon tear |
| Intervention | Study group: Arthroscopic rotator cuff repair and augmentation with platelet-rich fibrin matrix (Cascade® Autologous Platelet System, Musculoskeletal Transplant Foundation [MTF]). Control group: Arthroscopic rotator cuff repair without augmentation with platelet-rich fibrin matrix (Cascade® Autologous Platelet System, MTF). |
| Intervention type | Other |
| Primary outcome measure | 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. |
| Secondary outcome measures | Integrity of the repaired rotator cuff, as evaluated by MRI. |
| Overall study start date | 03/01/2007 |
| Completion date | 28/04/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 82 participants (41 participants per group) |
| Key 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 |
| Key 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 |
| Date of first enrolment | 03/01/2007 |
| Date of final enrolment | 28/04/2008 |
Locations
Countries of recruitment
- Italy
Study participating centre
Asur marche
Jesi
60010
Italy
60010
Italy
Sponsor information
Ospedale Civile (Italy)
Hospital/treatment centre
Hospital/treatment centre
Viale della Vittoria n.76
Jesi
60035
Italy
| Website | http://www.asurzona5.marche.it |
|---|---|
"ROR" |
https://ror.org/01nsxt963 |
Funders
Funder type
Hospital/treatment centre
Ospedale di Jesi (Italy)
No information available
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 |
