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st February 2021, Dublin, Ireland. X-Bolt Orthopaedics, a leading orthopaedic device company, highlights key results data from the WHITE4 trial, published in February’s Bone & Joint Journal, comparing the company’s flagship X-Bolt® XHS versus the gold standard Sliding Hip Screw. WHITE4 was the world’s largest randomised trial in hip fracture fixation (n=1,128) across ten UK specialist orthopaedic centres.
Sliding Hip Screw (SHS) fixation is a well-established treatment of trochanteric hip fractures. XHS differs only by the nature of fixation in the femoral head, using an expanding bolt instead of a lag screw.
In WHITE4, mean outcome scores at four months were better in XHS versus SHS patients 'as treated' and when reference is made to baseline pre-injury scores. Reflected into clinical practice, 20% of patients would tangibly perceive benefit with XHS versus SHS. The median age of patients was 86 years.
Reoperation rates, including femoral head ‘cut-out’ were the lowest ever recorded for a trial of this size. XHS had a 0.8% cut-out rate within a total ‘all-cause’ 2.3% reoperation rate. ‘Cut-out’ is a failure of implant anchorage that causes the lag screw to literally cut-out of the bone and into the hip joint. Data from almost 31,000 patients in the Norwegian Hip Fracture Register show SHS reoperation rates are between 4% and 5%, with cut-out accounting for the majority of these. The WHITE1 trial (n=100), published in 2016, showed a 0% XHS cut-out and reoperation rate.
Commenting on the publication of the WHITE4 paper, X-Bolt Orthopaedics’ CEO, Dr Brian Thornes said, “This was a large trial in a very frail patient group, whose main desire is to stay out of hospital and to maintain their independence. The data confirms the outstanding safety profile of the X-Bolt, which virtually eliminates ‘cut-out’ as an issue. I am also delighted the clinical impact translates into tangibly better outcomes for a significant number of patients.”
Having achieved FDA clearance of its hip plating and nailing systems in 2018, the Company has recently expanded its product portfolio. It has incorporated its technology into other long bone nailing systems, as well as an expandable spinal pedicle device. The Company has also recently improved the XHS expanding bolt, making it even easier to use, with a shorter tip-apex distance and compatibility with generic SHS barrel plates. X-Bolt Orthopedics’ expanded portfolio includes:
- Pendulum™ humeral nail with a distal expansion zone and strong humeral head fixation with an expanding bolt and angled screws.
- Springboard™ tibial nail featuring a strut to allow more proximal fixation and a micromotion suspension mechanism.
- Karibu™ femoral nail with double-ended X-Bolt for distal femur fixation, allowing greater weightbearing.
- The curved Metro™ jig with flexi-chain drive, allowing surgeons to operate ‘around a corner’.
The Company is currently raising finance to accelerate commercialisation of the entire portfolio in the US and globally.