01/08/2006
AO Technical Commission Approved

Early clinical experience with the LCP 3.5/4.5 systems

The aim of this prospective study was to systematically document the results of the first applications of the LCP system in routine clinical practice for a broad spectrum of indications. From March 2000 to February 2001 144 patients with 169 fractures were treated with the LCP system at six European trauma centers and at one American center. Patient recruitment was distributed across the individual centers as follows:

Kantonsspital Chur 39 patients
Kantonsspital Fribourg 37 patients
Wilhelminenspital Wien 24 patients
Hospital for Special Surgery New York 20 patients
Kantonsspital Aarau 9 patients
Spital Davos 8 patients
Kantonsspital Luzern 7 patients

The patient sample was comprised of 67 women and 77 men aged between 11 and 93 years. The period from accident to operation was 62 days on average (minimum 0 and maximum 917 days).

For this study, a follow-up rate of 88.2% was achieved. Five patients died before fracture healing was concluded without there being any recognizable link between the cause of death and the implant. One year after the operation, 130 fractures had gone on to complete and uneventful healing. For 19 patients a total of 27 unexpected adverse events were documented.

Adverse events No. of cases
Delayed or nonunion 5
Loss of reduction 1
Loosening of implant 1
Loosening of implant & loss of reduction 4
Breakage of implant 4
Infection 2
Postoperative nerve palsy 2
Refracture (2nd fracture close to implant) 4
Implant-related pain 2
Osteonecrosis 2

Table - Documented adverse events

 

The complications documented were of various degrees of severity and corresponded to a complication rate of 12.6%. None of these complications was determined to be purely implant-related. Instead, eight of the 18 revision operations were the consequence of technical inadequacies during the operation, or the stability of the osteosynthesis was overestimated

by the surgeon. The infection rate (2/151 of the fractures followed-up) is low (1.5%) for this heterogeneous patient sample that included numerous open fractures and many revision operations on patients who had already been operated on repeatedly (1.5%); this is especially true for the rate of secondary cancellous bone grafts (1.5%). The LCP system with its different types of screws and a very broad range of applications is of necessity associated with the hidden risks of error during operative planning and during operative intervention. The surgeons emphasized that, thanks to the possibility of fracture bridging fixation, the advantages of the LCP system lie especially in

  • its good purchase in osteoporotic bone;
  • the stable angle fixation of small, unstable fragments;
  • the reduction of primary cancellous bone grafting.

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