Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Comparison of Glenoid Component Position Using Intelligent Reusable Instrument (IRI) vs Standard Surgical Instruments
Brief Summary: The proposed clinical study will enroll patients indicated for standard of care anatomic total shoulder arthroplasty. They will receive all pre operative testing, intra-operative care including all implants and post operative care that is standard of care and specific to the surgeon and patients decisions for care. The only difference between the study groups will be the type of surgical instruments used to place the glenoid guide pin. In all cases the surgeon is able and allowed to use their own surgical judgment to place the guide pin, prepare the bone and place the desired implant. In cases that are randomized to the IRIS group the surgeon can use any and all of the standard instruments or guides provided by the implant manufacturer as the surgeon would use in the group of patients randomized to the standard surgical group. If the surgeon chooses not to use the IRIS instruments then this would be noted as a deviation in plan, the reasons recorded and the patient would be excluded from the study without post operative imaging and there pre - operative and intra - operative data would be analyzed for the purpose of understanding the reasons for failure of the IRIS technology to provide surgical assistance for guide pin placement. For patients included in the post operative data analysis will a study specific shoulder CT scan prior to discharge from the hospital to assess the position of the implant. Deviation in the location and position of the implant as compared plan will be our primary outcome measure. Investigators will compare difference between technologies, differences within and between surgeons and the influence of the severity of the pre operative pathology on the two methods of surgical care.


Options:
A: Arm Label: 1; Type: ACTIVE_COMPARATOR; Interventions: Procedure: Copeland or Global CAP resurfacing prosthesis | Arm Label: 2; Type: ACTIVE_COMPARATOR; Interventions: Procedure: Copeland or Global CAP resurfacing prosthesis | Intervention Type: PROCEDURE; Name: Copeland or Global CAP resurfacing prosthesis; Assigned to Arm(s): 1, 2
B: Intervention Type: PROCEDURE; Name: Cemented Humeral Stem; Assigned to Arm(s): N/A | Intervention Type: PROCEDURE; Name: Uncemented Humeral Stem; Assigned to Arm(s): N/A
C: Arm Label: 0 degrees humeral component version; Type: EXPERIMENTAL; Interventions: Device: 0 degrees humeral component version | Arm Label: 30 degrees humeral component retroversion; Type: EXPERIMENTAL; Interventions: Device: 30 degrees humeral component retroversion | Intervention Type: DEVICE; Name: 0 degrees humeral component version; Assigned to Arm(s): 0 degrees humeral component version | Intervention Type: DEVICE; Name: 30 degrees humeral component retroversion; Assigned to Arm(s): 30 degrees humeral component retroversion
D: Arm Label: Anatomic TSA using SOC Instrumentation; Type: ACTIVE_COMPARATOR; Interventions: Procedure: Anatomic Total Shoulder Arthroplasty | Arm Label: Anatomic TSA Using IRI Instrumentation; Type: EXPERIMENTAL; Interventions: Device: Anatomic TSA using IRI Instrumentation, Procedure: Anatomic Total Shoulder Arthroplasty | Intervention Type: DEVICE; Name: Anatomic TSA using IRI Instrumentation; Assigned to Arm(s): Anatomic TSA Using IRI Instrumentation | Intervention Type: PROCEDURE; Name: Anatomic Total Shoulder Arthroplasty; Assigned to Arm(s): Anatomic TSA Using IRI Instrumentation, Anatomic TSA using SOC Instrumentation

Answer: D