J-bone graft versus Latarjet
| ISRCTN | ISRCTN85886529 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN85886529 |
| Secondary identifying numbers | N/A |
- Submission date
- 09/02/2012
- Registration date
- 05/03/2012
- Last edited
- 15/02/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Injury, Occupational Diseases, Poisoning
Plain English summary of protocol
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
Contact information
Scientific
Muellner Hauptstraße 48
Salzburg
5020
Austria
Study information
| Study design | Multicenter prospective randomized controlled trial with blinded outcome assessment |
|---|---|
| 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 | 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 |
| Study objectives | 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(s) | Ethics Committee for the province of Salzburg (Ethikkommission für das Bundesland Salzburg), 08/02/2012, ref: 415-E/1439/5-2012 |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 01/03/2012 |
| Completion date | 01/03/2024 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 65 Years |
| Sex | Both |
| Target number of participants | 60 |
| Total final enrolment | 60 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/03/2012 |
| Date of final enrolment | 01/03/2014 |
Locations
Countries of recruitment
- Austria
Study participating centre
5020
Austria
Sponsor information
University/education
Department of Traumatology and Sports Injuries
Muellner Hauptstraße 48
Salzburg
5020
Austria
"ROR" |
https://ror.org/03z3mg085 |
|---|
Funders
Funder type
University/education
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 | 01/07/2019 | 15/02/2021 | Yes | No |
Editorial Notes
15/02/2021: The following changes have been made:
1. Publication reference added.
2. The final enrolment number has been added from the reference.
