Please select the eligibility criteria that correspond 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: Inclusion Criteria:

1. Patients with shoulder osteoarthritis with cartilage defect of the caput humeri and not the glenoid cavity
2. Aged 18 years or older and fit
3. Informed, written consent -

Exclusion Criteria:

1. Patients found unsuitable preoperatively for a resurfacing prosthesis
2. Patients aged 85 or older
3. Patients with rheumatoid arthritis
4. Patients who previously had undergone shoulder alloplasty or other major shoulder surgery (more than just diagnostic arthroscopy)
5. Patients unable to avoid NSAID after surgery
6. Patients requiring regular systemic steroid treatment
7. Female patients taking hormone substitution
8. Patients with metabolic bone disease
9. Severe shoulder instability with large rotator cuff defect ( will often necessitate special prosthesis components or even major soft-tissue surgery)
10. Female patients in the fertile age range who do not use safe anti-conception (oral contraception, intrauterine devices, depot gestagens, vaginal hormone rings) -
B: Inclusion Criteria:

1. Primary osteoarthritis of the shoulder of grade III or higher (Kellgren and Lawrence modified for the shoulder
2. Patients who have failed standard conservative management of their shoulder osteoarthritis

Exclusion Criteria:

1. Patients with secondary OA resulting from major joint trauma, infection, avascular necrosis, cuff tear arthropathy, chronic dislocation, massive rotator cuff tear, inflammatory arthropathy, Charcot's arthropathy or previous shoulder surgery (other than arthroscopic debridement)
2. Patients with preoperative CT scans of the shoulder which show insufficient glenoid bone stock that would not allow for implantation of a glenoid prosthesis
3. Active joint or systemic infection
4. Significant muscle paralysis
5. Major medical illness (life expectancy less then 2yrs or unacceptably high operative risk)
6. Unable to speak or read English/French
7. Psychiatric illness that precludes informed consent
8. Unwilling to be followed for 2 years
C: Inclusion Criteria:

* Patients undergoing primary reverse total shoulder arthroplasty
* Diagnosis of cuff tear arthropathy or primary OA with RCT
* Intact posterior rotator cuff and subscapularis preoperatively, as determined by surgeon-administered physical exam
* 18 years or older

Exclusion Criteria:

* Revision arthroplasty
* Diagnosis of rheumatoid arthritis, infection, acute trauma or instability
* Minors (under 18 years of age)

  * Prior open shoulder surgery
  * Concomitant latissimus dorsi transfer
  * Patients not undergoing a standard of care physical therapy protocol
  * Pregnant, patient-reported
  * Cognitively impaired
D: Inclusion Criteria:

* To be eligible for inclusion, a primary anatomic total shoulder arthroplasty must be indicated for the patient.

Exclusion Criteria:

* Age less than 18.

Answer: D