Table 2. Domain categories and reported outcomes, device, and metric within each domain (Updated to Reflect 2016 Data).
Domains (n = 11) | Outcomes (n = 383) | Measurement Devices | Specific Metric |
---|---|---|---|
Adverse Events (n = 25) |
Adverse events (7) Device associated adverse events (3) Biceps rupture (1) Device migration (1) Intraoperative bleeding (1) Intraoperative neurovascular injury (1) Intraoperative prosthetic fracture (1) Lack of unanticipated device related serious adverse events (1) Osteolysis (1) Postoperative bleeding (1) Postoperative infection (1) Postoperative instability (1) Procedure associated adverse events (2) Revision complications (1) |
Frequency (19) Unspecified (3) |
Value at a time point (20) Unspecified (2) |
Function/Disability (n = 16) |
Function (15) Function/disability (1) |
ASES (4) SST (4) Constant (3) SANE (2) Clinical outcome comparison (1) Unspecified (1) VAS (1) |
Value at a time point (13) Change from baseline (3) |
Global Assessment of Treatment Success (n = 60) |
Shoulder outcome score (58) Effectiveness (1) Impact of arm length difference on patient reported outcome (1) |
Constant (2) ASES (19) Oxford (5) PENN (3) DASH (3) QuickDASH (3) SSV (2) Modified Constant (1) Neer’s limited goals (1) SANE (1) SPADI (1) UCLA (1) |
Value at a time point (42) Change from baseline (12) |
Health Related Quality of Life (n = 68) |
Quality of life (15) Multidimensional aspects of health (8) Patient satisfaction (9) Activities of daily living (4) Disease or joint specific measure (4) General health component (2) Patient objective data (2) Patient subjective data (2) Anxiety/depression (1) Mental component summary (1) Mental health component (1) Mobility (1) Personal dependency status (1) Physical component summary (1) Physical function (1) Role emotional (1) Role physical (1) Self-care (2) Social function (1) Usual activities (1) VAS (1) Vitality (1) Willingness to have surgery performed again (1) |
EQ5D (11) SF-36 (10) WOOS (8) SF-12 (6) Unspecified (6) ASES (2) EQ5D5L (2) Patient assessment forms (2) VAS (2) 15D (2) ADLER (1) SPADI (1) Unspecified (1) PENN (1) 4-point rating (1) Constant (1) DASH (1) Quality of life survey (1) SST (1) |
Value at a time point (39) Change from baseline (20) Unspecified (1) |
Orthopedic Tests (n = 7) |
Test specific outcomes (4) Integrity & function of subscapularis tendon (2) Internal rotation extension (1) |
Abdominal compression test (2) Lift off test (2) Hornblower’s test (1) Speed’s test (1) Yergason’s test (1) |
Change from baseline (5) Value at a time point (2) |
Other (n = 23) |
Cost association (1) Health economics (1) Recovery time (1) Surgical time (1) |
Unspecified (3) Health resource utilization instrument (1) |
Value at a time point (4) |
Pain (n = 35) |
Pain (33) Pain at rest (1) Pain with active motion (1) Pain/discomfort (2) Pain/weakness (1) Preoperative pain (1) |
VAS (10) ASES (6) NRS (3) Unspecified (3) SANE (2) Clinical outcome comparison (1) Constant (2) SF-36 (1) SPADI (1) EQ5D (1) PENN (1) Likert scale (1) |
Value at a time point (21) Change from baseline (6) |
Radiologic Evaluation (n = 79) |
Acromiohumeral interval (1) Actual versus optimal glenosphere position (1) Actual versus predicted scapular notching (1) Bone density around the prosthesis (1) Bony apposition (2) Bony integration of the component (1) Clinical outcome comparison (1) Component loosening (3) Component position (1) Coracoid to glenohumeral joint distance (1) Coracoid to tuberosity distance (1) Correlation between bone density and prosthesis migration (1) Cumulative incidence of migration, radiolucency, osteolysis, and bone wear (1) Decreased component loosening (2) Decreased radiolucent lines (2) Determine if the use of autologous bone graft around the anchor-peg glenoid prosthesis correlate with bony apposition (1) Determine if the use of autologous bone graft around the anchor-peg glenoid prosthesis correlate with decreased radiolucent lines and component loosening (1) Determine if the use of autologous bone graft around the anchor-peg glenoid prosthesis correlate with functional outcomes (1) Difference in component migration between conventional and lateralized glenoid components (1) Evidence of movement or pending failure (1) Fixation to bone/early migration of the implants (1) Function (2) Glenoid component migration (1) Glenoid component position (3) Glenoid erosion (3) Glenoid status (2) Head to tuberosity distance (1) Humeral congruity (1) Humeral cortical thickness (1) Humeral stem position–valgus/varus (1) Humeral subluxation (1) Lateralization index (3) Location and placement of HRA device (1) Radiographic evaluation (3) Migration between cemented and press-fit RTSA humeral components (1) Migration of resurfacing prosthesis (1) No evidence of device failure (1) Postoperative clinical results (1) Qualitative documentation of surgical steps (1) Radiographic failure (1) Radiolucent lines (5) Scapular notching (1) Subacromial space (3) Subsidence (5) Tuberosity thinning (3) X-Rays (3) |
Radiograph (21) 3D CT (2) Unspecified (13) CT (12) Millimeters (2) Frequency (1) Radiostereometric analysis (3) Degrees (1) Plain radiograph (2) MRI (7) X-Ray (9) Modified Tingart & Al method (1) Intraoperative photographs (1) |
Value at a time point (61) Change from baseline (13) Unspecified (1) |
Range of Motion (n = 38) |
Range of motion (11) External rotation (4) Internal rotation (3) Active external rotation (2) Flexion (2) Passive external rotation (2) Active abduction (1) Active flexion (1) Active internal rotation (1) Active range of motion (1) Passive abduction (1) Passive flexion (1) Passive internal rotation (1) Passive range of motion (1) Postoperative clinical results (1) Scaption (1) |
Constant (10) Unspecified (17) Goniometer (4) Range of motion (1) ASES (1) Degrees (1) |
Change from baseline (21) Value at a time point (13) |
Strength (n = 16) |
External rotation strength (2) Flexion strength (2) Internal rotation strength (2) Strength (2) External abduction strength (1) Scapula abduction strength (2) Thumb down abduction strength (1) |
Pounds (5) Lafayette manual muscle testing system (4) Iso-force machine (2) Unspecified (1) |
Value at a time point (10) Change from baseline (2) |
Survival (n = 16) |
Implant survival (11) Revision/reoperation (3) Device success rate (1) Time to first revision (1) |
Frequency (6) Kaplan-Meier (5) Unspecified (5) |
Time to event (11) Value at a time point (4) Unspecified (1) |