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X-Bolt Hip Fracture Fixation Surgical Technique
X-Bolt is a hip fracture fixation orthopaedic surgical technique, similar in technique and construct to a standard sliding hip screw (SHS) but using an 'Expanding Bolt' in place of the lag screw.
The X-Bolt IM Hip Nailing System is intended for use in fracture fixation in the femur in adults with osteopenia or osteoporosis:
- Intertrochanteric and subtrochanteric fractures
- Segmental fractures
- Comminuted fractures
- Pathological fractures
- Fractures with bone loss
- Pseudoarthrosis, non-union, mal-union, and delayed union
- Surgically created defects such as osteotomies
The X-BOLT® Dynamic Hip Plating System is intended for use in fracture fixation in the proximal femur in adults with osteopenia or osteoporosis:
- Intracapsular and extracapsular fractures of the femoral neck
- Trochanteric fractures of the proximal femur
- Stable subtrochanteric fractures of the proximal femur
X-Bolt is FDA 510(k) approved[1] - X-Bolt Orthopaedics achieved FDA 510(k) clearance to market the X-Bolt Hip Nailing and Hip Plating fixation systems.
CLINICAL TRIALS
[edit]These systems received CE Mark approval in 2011 and have been the subject of two large clinical trials, WHITE1 (100 subjects)[2] and WHITE4 (1,140 subjects)[3][4][5], conducted by Oxford University and supported by NIHR Oxford Biomedical Research Centre.
- ^ FDA 510(k) approved number K181640 FDA.gov October 2018 510(k) Clearances
- ^ https://online.boneandjoint.org.uk/doi/abs/10.1302/0301-620X.98B5.37350 The Bone & Joint Journal 2016 May; 98(5):686-9.
- ^ https://bmjopen.bmj.com/content/8/1/e019944
- ^ https://www.ndorms.ox.ac.uk/clinical-trials/current-trials-and-studies/white
- ^ https://white4.octru.ox.ac.uk