Event groups | Definitions and specifications | Periodb | Agreement |
---|---|---|---|
Implant (device) [postoperative] | Events affecting any device used (e.g. nail, plate, prosthesis, external fixator) which are shown on adequate postoperative imaging (e.g. radiographs, ultrasound, CT) and which are associated with symptoms • Malpositioning c: implant not in its expected position • Radiolucency around the implant / Implant loosening: radiolucency relates to the occurrence/observation of radiolucent lines (RLL) at the bone-implant interface • Screw or bolt backout • Implant breakage: one part of the implant is broken • Migration: change of the position of an implant component relative to the bone it is supposedly fixed to | 12 months | 98% (125/128) |
Device [non-operative] | Events (e.g. breakage, loosening) involving any external device (e.g. sling, orthosis) used to immobilize the arm to support the fracture, which is associated with local clinical symptoms (e.g. local reactions such as skin lesions). | Time during use of the device(s) | |
Osteochondral | Events affecting the osteochondral tissue of the proximal humerus, clavicula and/or scapula Surgical treatment only: • New fracture (around the implant) • Screw / bolt cutout d All treatment interventions: • Bone formation / resorption (except head necrosis and tuberosity resorption) • Tuberosity migration / resorption • Head necrosis • Delayed union / nonunion • Loss of fracture reduction (except tuberosity migration) | 24 months | 97% (122/126) |
Shoulder instability | symptomatic shoulder associated with loss of alignment of the articulating surface of the humeral head with the glenoid surface • Subluxation: non arm position-dependent eccentric misalignment with residual contact. • Dislocation: non arm position-dependent complete loss of contact of the articulating surfaces. • Dynamic instability: arm position-dependent loss of contact of the articulating surfaces apparent on physical examination and/or visible on functional radiographs (horizontal flexion/extension view in 90° of abduction and true anteroposterior (AP) view in 60° of abduction). | 12 months | 96% (121/126) |
Peripheral neurological | Events resulting from peripheral neurological injury at the fracture site, which is associated with sensory and/or motor and/or autonomic disturbance • Sensory and/or motor disturbance: Affected nerve(s) -Cervical or brachial plexus -Branch neuropathy (suprascapular, musculocutaneous, median, ulnar, radial, axillary, dorsal scapular, long thoracic, spinal accessory, thoracodorsal, cutaneous nerves of arm and forearm) • Autonomic disturbance: Complex regional pain syndrome (CRPS) Neurological injury may be classified by a neurologist according to Seddon 15 (i.e. neurapraxia, axonotmesis, neurotmesis) and/or Birch 16 (degenerative, short conduction block, prolonged condition block) | 3 months | 97% (165/170) e |
Vascular | Events involving laceration, avulsion, contusion, puncture or crush injury to an artery or vein at the injured arm • Hematoma which requires evacuation by needle or surgery • Superficial and deep thrombosis at the involved extremity • Ischemia of the involved extremity which requires additional intervention | 30 days | 98% (124/127) |
Infections | Fracture-related Infections (FRI) f Definition of terms and specifications adopted from a 2018 FRI consensus definition 17 | 24 months | 98% (124/127) |
Superficial soft tissue | Events affecting the superficial soft tissues (i.e. skin and subcutaneous tissue) at and around the surgical site/wound that do not affect deep soft tissues (i.e. fascia, muscle, articular capsule) and that require additional treatment • Early events 30 days: edema; emphysema; burn; delayed wound healing; hypersensitivity reaction; skin necrosis; skin bulla • Late events within the first 6 months: hypertrophic scar and keloid (except if known history of previous development) | 30 days to 6 months | 98% (165/168) e |
Deep soft tissue | Events affecting the deep soft tissues (i.e. fascia, muscle, articular capsule), except infections • External muscular envelope: deltoid-pectoralis major • Subacromio-deltoid-coracoid bursa (space) • Rotator cuff muscle-tendon and biceps tendon • Capsule-synovium | 12 months | 97% (122/126) |