Condition category
Injury, Occupational Diseases, Poisoning
Date applied
06/01/2010
Date assigned
02/02/2010
Last edited
02/02/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Roberto Castricini

ORCID ID

Contact details

Asur marche
Ospedale di Jesi
U. O. Di ortopedia e traumatologia
Jesi
60010
Italy

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

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

Acronym

Study hypothesis

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

Local ethics committee (Comitato etico dell’Ospedale di Iesi, ASUR MARCHE) approved on the 2nd January 2007

Study design

Interventional randomised single centre single-blind placebo-controlled cross-over study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

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

Phase

Not Applicable

Drug names

Primary outcome measures

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 trial start date

03/01/2007

Overall trial end date

28/04/2008

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

82 participants (41 participants per group)

Participant 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

Recruitment start date

03/01/2007

Recruitment end date

28/04/2008

Locations

Countries of recruitment

Italy

Trial participating centre

Asur marche
Jesi
60010
Italy

Sponsor information

Organisation

Ospedale Civile (Italy)

Sponsor details

Viale della Vittoria n.76
Jesi
60035
Italy

Sponsor type

Hospital/treatment centre

Website

http://www.asurzona5.marche.it

Funders

Funder type

Hospital/treatment centre

Funder name

Ospedale di Jesi (Italy)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes