Contact information
Type
Scientific
Primary contact
Mr Nicola Archetti Netto
ORCID ID
Contact details
Department of Orthopaedics and Traumatology
Universidade Federal de São Paulo
Rua Borges Lagoa
783 - 5th Floor
São Paulo
04038-032
Brazil
+55 11 5571 6621
narchetti@uol.com.br
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Repair of Bankart lesion in traumatic anterior shoulder instability: open surgery versus arthroscopic technique - a randomised controlled trial
Acronym
Study hypothesis
There is no difference between open versus arthroscopic interventions for treating traumatic anterior shoulder instability.
Ethics approval
The Ethics Committee of the Universidade Federal de São Paulo/Hospital São Paulo approved in August 2003 (ref: CEP 0901/03 UNIFESP)
Study design
Randomised active controlled parallel group clinical trial
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
Traumatic anterior shoulder instability
Intervention
After arthroscopic examination, participants were randomised to:
1. Open surgery
2. Arthroscopic surgery
Total duration of treatment was approximately 1 hour for open surgery and 1 hour for arthroscopy. Total duration of follow-up was from 20 to 56 months for open surgery and from 18 to 56 months for arthroscopy.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measure
1. Disability of Arm Shoulder and Hand (DASH) Questionnaire
2. UCLA Shoulder Rating Scale
3. Rowe Score for Instability
Identical care program for rehabilitation was done in each of compared groups. Following enrolment in the study, all the participants were assessed every week during the first 2 weeks and at the 4th and 8th weeks; thereafter, monthly until the final examination. All primary and secondary outcomes were reported.
Secondary outcome measures
Range of movement: passive range of motion measurements, specifically forward flexion and internal and external rotation at 90° of abduction, were recorded and compared with the patients' nonoperative side.
Identical care program for rehabilitation was done in each of compared groups. Following enrolment in the study, all the participants were assessed every week during the first 2 weeks and at the 4th and 8th weeks; thereafter, monthly until the final examination. All primary and secondary outcomes were reported.
Overall trial start date
01/11/2003
Overall trial end date
01/12/2006
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Adults aged 18 - 40 years, either sex
2. Radiographic confirmation of a first-time anterior shoulder dislocation caused by an external force applied to the shoulder in a fall, or other forceful injury
3. No associated fracture visible on conventional radiographs at the time of presentation
4. Clinical history and symptoms of anterior shoulder instability
5. No medical contraindications to general anaesthesia
6. Detection of a Bankart lesion (anteroinferior capsulolabral detachment) on the arthroscopic examination of the shoulder
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
50 participants
Participant exclusion criteria
1. Aged under 18 or over 40 years
2. Patients with generalised joint laxity, bilateral instability, multidirectional instability, and an additional soft-tissue injury that could affect joint stability
3. Patients with convulsive disorders, collagen diseases, previous surgery of the shoulder and any other condition that affects the shoulder mobility
4. Cerebrovascular disease or other severe medical illness
5. Inability to give informed consent or to complete questionnaires
Recruitment start date
01/11/2003
Recruitment end date
01/12/2006
Locations
Countries of recruitment
Brazil
Trial participating centre
Department of Orthopaedics and Traumatology,
São Paulo
04038-032
Brazil
Sponsor information
Organisation
Universidade Federal de Sao Paulo (UNIFESP) (Brazil)
Sponsor details
c/o Nicola Archetti Netto
Department of Orthopaedics and Traumatology
Rua Borges Lagoa
783 - 5th Floor
São Paulo
04038-032
Brazil
+55 11 5571 6621
narchetti@uol.com.br
Sponsor type
University/education
Website
Funders
Funder type
University/education
Funder name
Universidade Federal de Sao Paulo (UNIFESP) (Brazil)
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
Basic results (scientific)
Publication list
1. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/22342199
Publication citations
-
Results
Archetti Netto N, Tamaoki MJ, Lenza M, dos Santos JB, Matsumoto MH, Faloppa F, Belloti JC, Treatment of Bankart lesions in traumatic anterior instability of the shoulder: a randomized controlled trial comparing arthroscopy and open techniques., Arthroscopy, 2012, 28, 7, 900-908, doi: 10.1016/j.arthro.2011.11.032.