About this trial
Total shoulder arthroplasty is an effective procedure to improve patients function and to relieve shoulder pain in cases of glenohumeral arthritis. The main challenge of this procedure is implanting the glenoid component. Indeed, surgical exposure is difficult and proper visualization of the glenoid is demanding. The current free-hand method is not precise and especially unreliable in glenoids with severe deformity. Inappropriate reaming and glenoid positioning can cause more bone loss during surgery.
In anatomic prostheses, glenoid component fixation is demanding and is the first component to present loosening at long term follow-up. When it comes to reverse arthroplasty, the glenoid component, once again, requires the most attention. Malpositioning of the glenosphere can cause notching, loosening, and instability.
In order to prevent these complications, precision in glenoid implantation is key. To this end, intraoperative computer navigation would be a helpful tool, but the increased expenses in computer equipment represent massive costs and possibly increases in surgical time. A more affordable option is a personalized guide, for which the only extra expense is the customized guide. These guides are based on precise 3D CT scan templates. Previous studies have evaluated the precision of the guide in vivo and in vitro, but none have measured it in a randomized study. As it represents additional costs, its efficacy needs to be proven before widespread use.
This method may also provide secondary benefits, such as decreasing operating time, lowering short- and long-term complications, and improving efficacy.
The objective of this study is to evaluate the performance of a patient specific glenoid guide.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients with shoulder osteaoarthritis and AVN
Disqualifiers
Patients with previous shoulder arthroplasty
Patients with inflammatory arthritis and tumor
Patients with previous shoulder surgery with metal implant
Patients refusing 2-year follow-up
Trial design
Parallel
Treatments tested in this trial
TSA standard
Procedure/SurgeryGlenoid preparation will be done with 2D CT-Scan
RTSA standard
Procedure/SurgeryGlenoid preparation will be done with 2D CT-Scan
TSA Blueprint
Procedure/SurgeryGlenoid preparation will be done with Blueprint software
RTSA Blueprint
Procedure/SurgeryGlenoid preparation will be done with 2D CT-Scan
Treatment groups
Trial outcomes
Primary outcomes
Radiological evaluation 1
Comparing the precision of the glenoid implantation during the surgery between both group
Secondary outcomes
Radiological evaluation 2
Comparaison of the glenoid fixation durong the surgery, between both group
Glenoid bone loss
Comparaison of the glenoid bone loss between both group
Surgical time
Comparaison og the surgery time between both group
Blood test
Evaluation of the glenoid quality with nutritional status
Sponsors and contacts
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