Open surgery versus arthroscopy for treating traumatic instability of the shoulder in adults

ISRCTN	ISRCTN22171602
DOI	https://doi.org/10.1186/ISRCTN22171602
Secondary identifying numbers	N/A

Submission date: 29/06/2010
Registration date: 06/08/2010
Last edited: 30/10/2012

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

Plain English summary of protocol

Not provided at time of registration

Contact information

Mr Nicola Archetti Netto
Scientific

Department of Orthopaedics and Traumatology
Universidade Federal de São Paulo
Rua Borges Lagoa
783 - 5th Floor
São Paulo
04038-032
Brazil

Phone	+55 11 5571 6621
Email	narchetti@uol.com.br

Study information

Study design	Randomised active controlled parallel group clinical trial
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	Repair of Bankart lesion in traumatic anterior shoulder instability: open surgery versus arthroscopic technique - a randomised controlled trial
Study objectives	There is no difference between open versus arthroscopic interventions for treating traumatic anterior shoulder instability.
Ethics approval(s)	The Ethics Committee of the Universidade Federal de São Paulo/Hospital São Paulo approved in August 2003 (ref: CEP 0901/03 UNIFESP)
Health condition(s) or problem(s) studied	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
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 study start date	01/11/2003
Completion date	01/12/2006

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Upper age limit	40 Years
Sex	Both
Target number of participants	50 participants
Key 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
Key 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
Date of first enrolment	01/11/2003
Date of final enrolment	01/12/2006

Locations

Countries of recruitment

Brazil

Study participating centre

Department of Orthopaedics and Traumatology,

São Paulo
04038-032
Brazil

Sponsor information

Universidade Federal de Sao Paulo (UNIFESP) (Brazil)
University/education

c/o Nicola Archetti Netto
Department of Orthopaedics and Traumatology
Rua Borges Lagoa, 783 - 5th Floor
São Paulo
04038-032
Brazil

Phone	+55 11 5571 6621
Email	narchetti@uol.com.br
"ROR"	https://ror.org/00bkgf580

Funders

Funder type

University/education

Universidade Federal de Sao Paulo (UNIFESP) (Brazil)

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

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/07/2012		Yes	No