Objective: to study the clinical performance of a new intramedullary nail, which is introduced in a retrograde way, for the treatment of humeral shaft fractures.
Design: prospective, non-randomized multicentrical clinical study.
Setting: Level I trauma centers in 4 European countries.
Patients: In a two year period, 102 humeral shaft fractures in 102 patients were nailed. Seventy-three fresh fractures, 12 pseudarthroses, 3 refractures and 14 pathological fractures were involved. Decision for nailing was taken by each surgeon individually. The diaphysis was defined as the part of the humerus between two centimetres below the surgical neck and five centimetres above the olecranon fossa. Sixty-six fractures were closed: 62 grade I and 4 closed grade II and III. There were also 7 open fractures, 4 grade I, 2 grade II and one grade III.
Intervention: all fractures were stabilized with the new unreamed humeral nail (UHN), which was introduced in a retrograde way.
Main outcome measurements: 42,5% of operations were performed in less than one hour, 82,4% in less than 90 minutes (skin to skin). In four patients (3,9%), additional fissures or fractures occurred on the entry portal, in one patient (1%) an additional diaphyseal fracture occurred during nail insertion. There were 4 (3,9%) secondary radial nerve palsies. Seventy-five fractures could be followed up until fracture healing, 58 fresh fractures, 9 pseudarthroses, 2 refractures and 6 pathological fractures. Five fractures needed more than 8 months for fracture healing, in all these patients (5/75 = 6,7%) secondary surgery was necessary. In three patients, inter-fragmentary compression was used with the UHN, once cancellous bone grafting was performed and in one patient changement of procedure to plate and screw osteosynthesis was considered necessary. Sixty-seven patients (89,4%) showed an excellent shoulder function and 7 (9,3%) an acceptable one, 66 (88,0%) an excellent elbow function and 7 (9,3%) an acceptable one at the time of fracture healing.
Conclusions: The unreamed humeral nail (UHN) is a very elegant device for intramedullary stabilization of fresh and pathological fractures and pseudarthroses. The retrograde approach is safe when the nail is introduced carefully through an appropriate entry portal. In case of good fragment adaptation and sufficient stability, an unproblematic fracture healing can be expected.