Plain English Summary
Background and study aims
Dislocations are joint injuries that force the ends of the bones out of position. There are two standardized and widely used operations to stabilize the shoulders of patients with multiple anterior shoulder dislocations. One technique is the Latarjet procedure and the other is the J-bone graft technique. The aim of this study is to investigate the clinical and radiological outcomes of patients after these two operations and in the long term to detect any differences in the occurrence of osteoarthritis.
Who can participate?
Patients aged 18-65 with post-traumatic recurrent anterior shoulder instability.
What does the study involve?
Participants complete questionnaires and undergo a physical examination, x-rays of both shoulders, and a CT scan before surgery. They are then randomly allocated to one of the two operations. After surgery another CT scan is performed. In addition all participants are asked to fill out questionnaires at 6, 12 and 24 months after surgery. At 12 and 24 months another CT scan is performed to investigate the affected shoulders. 5 and 10 years after surgery the participants are invited to fill out the questionnaires again and x-rays of both shoulders are taken in order to check for early onset osteoarthritis.
What are the possible benefits and risks of participating?
Not provided at time of registration.
Where is the study run from?
Department of Traumatology and Sports Injuries of the Paracelsus Medical University in Salzburg, Austria, and the Department for Shoulder and Elbow Surgery of the Atos Clinic in Munich, Germany.
When is the study starting and how long is it expected to run for?
March 2012 to March 2024.
Who is funding the study?
Department of Traumatology and Sports Injuries of the Paracelsus Medical University in Salzburg, Austria.
Who is the main contact?
Dr Philipp Moroder
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Clinical outcomes and osseous remodeling in Latarjet and J-bone grafting for post-traumatic recurrent anterior shoulder instability: a prospective randomized controlled trial with blinded outcome assessment
Acronym
Study hypothesis
The clinical outcome of patients treated with a J-bone graft for post-traumatic recurrent anterior shoulder instability prevails over the outcome in patients receiving a Latarjet procedure.
Ethics approval
Ethics Committee for the province of Salzburg (Ethikkommission für das Bundesland Salzburg), 08/02/2012, ref: 415-E/1439/5-2012
Study design
Multicenter prospective randomized controlled trial with blinded outcome assessment
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
Post-traumatic recurrent anterior shoulder instability with significant glenoid defect
Intervention
Latarjet procedure according to Young et al. (JSES 2011) using the Arthrex Latarjet set, immobilization in a shoulder sling, physiotherapy, follow up at 6 months, 12 months, 24 months, 5 years and 10 years
J-bone graft procedure according to Auffarth et al. (AJSM 2008), immobilization in a shoulder sling, physiotherapy, follow up at 6 months, 12 months, 24 months, 5 years and 10 years
Intervention type
Procedure/Surgery
Phase
Drug names
Primary outcome measure
The clinical outcome at 6 months, 12 months, 24 months, 5 years, and 10 years measured using the Western Ontario Shoulder Instability Index of patients treated with a J-bone graft or Latarjet procedure for post-traumatic recurrent anterior shoulder instability with significant glenoid defect
Secondary outcome measures
1. The resorption/remodeling of both graft types is compared using pre-operative, post-operative, 12-months and 24 months post-operative CT imaging
2. The clinical outcome at 6 months, 12 months, 24 months, 5 years, and 10 years measured using the Subjective Shoulder Value of patients treated with a J-bone graft or Latarjet procedure for recurrent anterior shoulder instability
3. The clinical outcome at 6 months, 12 months, 24 months, 5 years, and 10 years measured using the Rowe Score and range of motion of patients treated with a J-bone graft or Latarjet procedure for recurrent anterior shoulder instability
4. Radiological assessment of osteoarthritic changes in the operated joint compared to the contra-lateral joint by bi-plane radiography of both shoulders at 5 years and 10 years follow up compared to the base-line images of both shoulders
Overall trial start date
01/03/2012
Overall trial end date
01/03/2024
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Female or male paient of age 18-65 diagnosed with post-traumatic recurrent anterior shoulder instability and significant bony glenoid defect (15-30% of the glenoid surface area)
2. Obtained written consent from the patient
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
60
Participant exclusion criteria
1. Patient prefers one surgical technique over the other or does not consent to a surgical treatment at all
2. Pre-existing ipsilateral shoulder pathology
3. Previous ipsilateral shoulder surgery except open or arthroscopic Bankart repair
4. Infection
5. Neuro-muscular disease
6. Lack of compliance
7. Problems with attending the regular follow-ups
8. Chronic alcohol or drug abuse
Recruitment start date
01/03/2012
Recruitment end date
01/03/2014
Locations
Countries of recruitment
Austria
Trial participating centre
Muellner Hauptstraße 48
Salzburg
5020
Austria
Funders
Funder type
University/education
Funder name
Department of Traumatology and Sports Injuries, Paracelsus Medical University, Salzburg (Austria)
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