Condition category
Musculoskeletal Diseases
Date applied
16/12/2010
Date assigned
28/02/2011
Last edited
28/02/2011
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

Prof Stefano Gumina

ORCID ID

Contact details

Via Tacito
74
Rome
00193
Italy
s.gumina@tiscali.it

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

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

Acronym

Study hypothesis

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

Ethics Board of the University of Rome "Sapienza" and Policlinico Umberto I approved in 2008 (ref: 2/08)

Study design

Prospective randomised controlled study

Primary study design

Interventional

Secondary study design

Non 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 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

Phase

Not Applicable

Drug names

Primary outcome measures

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 trial start date

19/05/2008

Overall trial end date

11/10/2010

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

80 consecutive patients

Participant 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

Recruitment start date

19/05/2008

Recruitment end date

11/10/2010

Locations

Countries of recruitment

Italy

Trial participating centre

Via Tacito, 74
Rome
00193
Italy

Sponsor information

Organisation

Orthopaedic Clinic University of Rome "Sapienza" (Italy)

Sponsor details

c/o Prof Franco Postacchini
Piazzale Aldo Moro
5
Rome
00185
Italy

Sponsor type

University/education

Website

Funders

Funder type

University/education

Funder name

Sapienza University of Rome (Italy)

Alternative name(s)

Sapienza University of Rome

Funding Body Type

government organisation

Funding Body Subtype

government non-federal

Location

Italy

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