Study of Personalized Instrument in Total Shoulder Arthroplasty The P.I.T.S.A. Study

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-99
SponsorUniversité de Montréal

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • TSA standard

    Procedure/Surgery

    Glenoid preparation will be done with 2D CT-Scan

  • RTSA standard

    Procedure/Surgery

    Glenoid preparation will be done with 2D CT-Scan

  • TSA Blueprint

    Procedure/Surgery

    Glenoid preparation will be done with Blueprint software

  • RTSA Blueprint

    Procedure/Surgery

    Glenoid preparation will be done with 2D CT-Scan

Treatment groups

112 Participants
are divided into 4 treatment groups
Group A: TSA StandardActive comparator 1 intervention
Group B: RTSA standardActive comparator 1 intervention
Group C: TSA blueprintExperimental treatment 1 intervention
Group D: RTSA blueprintExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Radiological evaluation 1

Comparing the precision of the glenoid implantation during the surgery between both group

Time frame
2 weeks post-op

Secondary outcomes

1

Radiological evaluation 2

Comparaison of the glenoid fixation durong the surgery, between both group

Time frame
2 years
2

Glenoid bone loss

Comparaison of the glenoid bone loss between both group

Time frame
At surgery
3

Surgical time

Comparaison og the surgery time between both group

Time frame
At surgery
4

Blood test

Evaluation of the glenoid quality with nutritional status

Time frame
Before surgery

Other outcomes

Sponsors and contacts

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