Carbon Fiber-Reinforced PEEK Versus Titanium Tibial Intramedullary Nailing: A Preliminary Analysis and Results.

OBJECTIVES

Standard titanium nails (TN) or carbon fiber-reinforced PEEK nails (CFN) were compared to evaluate impact of material on fracture union, healing time, knee/ankle, and barometric pain.

DESIGN

Longitudinal cohort evaluated retrospectively comparing 2 periods using 2 implant types.

SETTING

Single surgeon series at one Level II Trauma Center.

PATIENTS: Standardized treatment protocol. Fifty-six tibial fracture patients suitable for intramedullary nailing over 5-year period.

INTERVENTION: First period-TN; second period-CFN.

MAIN OUTCOME: Measurements: standard demographic data: OTA/AO fracture classification, fracture location, and nail type.

OUTCOME PARAMETERS: cumulative healing at standard time intervals, infection/nonunion, associated injuries, knee/ankle, barometric pain, and implant removal. Statistical analysis comparing incident healing.

RESULTS

Patient populations were not statistically different regarding demographics and fracture type/location, although there was a trend toward greater fracture severity/more associated injuries in CFN group. In 56 patients, 26 received CFN and 30 received TN. Healing rates were reported at each time interval. 8 weeks: TN-0%, CFN-19%; 12 weeks: TN-17%, CFN-69%; 16 weeks: TN-57%, CFN-92%; 20 weeks: TN-87%, CFN-96%; and 24 weeks: TN-97%, CFN-96% (P < 0.0001 every interval except 24 weeks). Each group had one infected nonunion in an open fracture that healed with subsequent treatment. There was a trend toward less barometric pain with CFN that did not reach statistical significance (P = 0.065). No statistical differences with knee/ankle pain (P = 0.109)/removal of implant (P = 0.269) potentially due to low power of pilot study.

CONCLUSIONS

In this pilot study evaluating CFR-PEEK intramedullary nail for tibial shaft fractures, there was a demonstrated accelerated healing times compared to titanium with a potential for less barometric pain.

LEVEL OF EVIDENCE: Therapeutic Level III. See Instructions for Authors for a complete description of levels of evidence.