Objectives:
There is only sparse data on clinical results and complications of the third-generation Gamma nailing system (Gamma3, Stryker). Therefore, we started a large multi-centre case series in 2008. The aim of this paper is to present the study design and early results of a single arm of a prospective, consecutive, monitored, post-market follow-up evaluation of Gamma3 nails.
Methods:
From September 2009 to January 2012, 154 consecutive patients with an average age of 80 ± 1.43 years (50-99 years) and a trochanteric femoral fracture were included in the local arm of the trial. All patients that fulfilled the inclusion criteria were treated with a Gamma3 nail. Preoperative variables included age, gender, fracture classification, walking ability (Merle d'Aubigné score), daily activity level (retrospective Zuckerman score), ASA rating of operative risk, waiting time for operation, use of walker or crutches and body mass index (BMI). Skin-to-skin time, fluoroscopy time, blood loss, intraoperative complications and device information were recorded for each patient. Follow-up postoperative assessment was undertaken at 4, 12 and 24 months. Hip range of motion, pain around the hip and the tight, walking ability (Merle d'Aubigné score, Sahlgrenska mobility score) and management of daily life (Zuckerman score) were used to evaluate the outcome.
Results:
The descriptive data of age, gender, BMI, ASA classification, fracture type and skin-to-skin time is similar to other studies. Median fluoroscopy time was 62 seconds (range: 4-225 seconds) and significantly shorter in closed reductions. No intraoperative implant-related complication was recorded. A cut-out of the leg-screw during assessment period occurred in 2.6% patients (n = 4). At the 12-month assessment two (1.8%) non-unions were identified and two patients (1.8%) had broken the femoral shaft below the 180 mm nail after a fall. Analysis of the scores showed significantly declined mobility and activity in daily life four months after operation which increased significantly from four to 12 months and increased slightly between 12 and 24 months after fracture.
Conclusion:
A low implant-associated complication rate was achieved in geriatric patients with trochanteric femoral fractures using the Gamma3 nail. A better outcome concerning mobility, activity in daily life and complications compared to the Gamma2 nail could not be found in comparison to historic data.