Long Term Follow-up After Primary or Revision Shoulder Arthroplasty With a Patient- Specific Glenius Implant

The Constant-Murley score is a clinical outcome scale composed of a number of individual parameters, defining the level of pain, the ability to carry out the normal daily activities of the patient, mobility and strength of the arm. The scores range from 0 (worst clinical outcome) to 100 (best clinical outcome).

The SST is a function scale with 12 items, used to assess improvement in shoulder function after treatment interventions and to check the patient's ability to tolerate or perform 12 activities of daily living. The scores range from 0 (worst functional outcome) to 100 (best functional outcome).

The OSS is a 12-item patient-reported outcome specifically designed and developed for assessing outcomes of shoulder surgery e.g. for assessing the impact on patients' quality of life of degenerative conditions such as arthritis and rotator cuff problems. The score ranges from 0 (no pain or functional impairement) to 60 (worst pain and functional impairement).

EQ-5D is a standardized patient-reported outcome for measuring generic health status. The questionnaire has two components: a health state description measured in terms of five dimensions (5D); mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. and a general evaluation of their overall health status using the visual analogue scale (EQ-VAS).

The VAS pain score is a patient-reported evaluation of pain intensity on a Visual Analogue Scales (VAS) between 0 (no pain) and 100 (worst pain imaginable).

translational deviation (in mm) of the implant position on post-operative shoulder CT scan when compared to the planned position on the pre-operative CT scan.

Rotational deviation (in degrees) of the implant position on post-operative shoulder CT scan when compared to the planned position on the pre-operative CT scan.

translational deviation (in mm) on a shoulder CT scan 1 year after surgery, compared to the position on the post-operative CT scan.

Rotational deviation (in degrees) on a shoulder CT scan 1 year after surgery, compared to the position on the post-operative CT scan.

scapular notching will be graded according to the Sirveaux classification system (2004) on a shoulder radiograph. The classification goes from 0 (no notching) to 4 (erosion over the inferior screw with extension under the baseplate)

Radiolucencies surrounding the glenoid component will be graded according to the system of Lazarus (Lazarus et al 2002) on a shoulder radiograph. The classification goes from 0 (no lucensies) to 5 (gross lucensies and radiographic loosening)

periarticular heterotopic ossification (HO) will be scored according to a modified Brooker classification system of HO of the hip (Verhofste et al 2016) on a shoulder radiograph. The classification goes from 0 (no ossifications) to 3 (complete ankylosis of the shoulder)

Implant survival will be calculated by calculating the rate of implant revision surgeries up to 5 years after surgery.

the number and kind of (severe) adverse (device) events: device/shoulder related A(D)Es, SA(D)Es and device deficiencies that could have led to an SAE will be collected.