Condition category
Injury, Occupational Diseases, Poisoning
Date applied
29/06/2010
Date assigned
06/08/2010
Last edited
30/10/2012
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

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 measures

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

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

Results - basic reporting

Publication summary

1. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/22342199

Publication citations

  1. 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.

Additional files

Editorial Notes