Polyaxial Locking Plates in Treating Distal Humeral Fractures
Condition: Distal Humerus Fracture
MeSH terms: Fractures, Bone; Humeral Fractures; Humeral Fractures, Distal
Study type: Interventional

Summary: 
      20 patients with distal humeral fractures (AO 13-A1 - AO 13-C3) were included in the current
      study since 2014. After completing the randomization plan, patients were distributed into two
      groups for different variable angle locking plates (DePuy Synthes VA-LCP vs. Medartis Aptus
      Elbow). Clinical and radiological follow-ups were conducted 6 weeks, 12 weeks, 6 months and
      12 months after the operation.
    

Detailed description: 
      Before study initiation the approval of the local ethics committee of (Trial Number 253/14)
      was obtained. The clinical trial included 20 patients with fractures of the distal humerus
      recruited from a level-one university trauma centre. Patient recruitment was conducted
      between 03/2014 and 12/2015. Fractures of the distal humerus, as defined by the AO
      classification system (AO 13-A1 - AO 13-C3), were included in this study as they were
      identified by the treating surgeon being applicable for locking plate treatment and after
      written informed consent of the patients was obtained. All patients were randomized following
      a randomization plan (Randlist, DatInf GmbH, Tübingen, Germany) for either being treated with
      the DePuy Synthes VA-LCP 2.7/3.5 mm (DePuy Synthes, Umkirch, Germany) or with the Medartis
      Aptus Elbow system 2.0/3.8 mm (Medartis, Basel, Switzerland). Both systems include
      anatomically preshaped, polyaxial angular stable locking plates in various sizes. Angle
      stable screw positioning with the freedom of +/- 15° off-axis screw placement gives the
      surgeon a large variety in both systems.

      The inclusion criteria involve all patients from the age of 18 to 95 years who suffered from
      a distal humeral fracture (AO 13-A1 - AO 13-C3) that had to undergo operative treatment. The
      exclusion criteria involve all under-aged patients (< 18 years), pregnant patients and
      patients with a mental disorder as well as patients under comprehensive legal support. In
      addition, pathological fractures had been excluded from the study.

      Surgical technique

      All patients were operated by experienced upper extremity surgeons. The mean interval between
      injury and operation was 2.4 days (range 0-12 days). General anaesthesia was used in all
      cases and a single dose of 1.5 mg cephalosporin was given preoperatively for prophylaxis.
      Patients were positioned in prone position with the injured arm on a radiolucent, small
      padded arm holder. Under tourniquet control, the posterior approach (Bryan-Morrey) to the
      distal humerus was performed in all cases. Additional olecranon osteotomy was performed in 7
      cases (3x DePuy Synthes vs. 4x Medartis Aptus Elbow) presenting with AO type 13 C2 and AO
      type 13 C3 fractures. Postoperatively, physiotherapy was initiated using the same
      rehabilitation protocol for both groups. Passive and active assisted ROM was permitted
      immediately without limitations, while weight bearing was restricted for 6 weeks.

      Follow-up evaluation

      All patients were initially followed-up 6 weeks after operation. Additional follow-ups were
      performed 3, 6 and 12 months postoperatively. The follow-up examinations were carried out by
      an independent investigator not involved in patient´s initial surgical treatment (MC). After
      the assessment of pain using the visual analogue scale (VAS) was documented, ROM and
      collateral ligament stability were documented on standardized scoring sheets. For subjective
      evaluation, patients rated their satisfaction for elbow use on a scale of 1 to 6 (1-highly
      satisfied; 2-satisfied; 3-moderate; 4-sufficient; 5-unsatisfied; 6-very unsatisfied).
      Moreover, sensomotoric disturbances and postoperative complications were recorded. For
      functional upper extremity and elbow scoring the shortened Disabilities of the Arm, Shoulder
      and Hand Score (QuickDASH) and the Mayo Elbow Performance Score (MEPS) were comprised.
      Postoperative x-rays were evaluated with special respect to bony healing, secondary loss of
      reduction and heterotopic ossifications.

      Statistics

      Statistical analyses were performed using the statistical software SigmaStat (version 3.5;
      Systat Software, San Jose, CA, USA). The scores at certain time points were compared with an
      independent t test after a normality check had been passed and equal variances had been
      detected. Normal distributed data with unequal variances would have been compared with
      Welch's t test. Arbitrarily data was tested with Mann-Whitney U test. The significance level
      was set at p= 0.05.
    

Intervention name(s): Medartis; Synthes
Intervention type(s): Procedure; Procedure
Intervention description(s): Surgery using the medartis implant; Surgery using the Synthes implant
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: locking plate; anatomical preshaped; polyaxial; outcome