WHITE4 trial shows lowest ever cut-out rate using X-Bolt XHS, with over 90% of patients having better outcome scores
DUBLIN, Feb. 1, 2021 /PRNewswire/ -- 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, patient wellbeing outcome scores at four months were better in more than 90% of XHS versus SHS patients, rising to 95% favouring XHS when 'crossovers' (XHS-allocated who actually received SHS) are excluded and reference is made to baseline pre-injury scores. Reflected into clinical practice, greater than 20% of patients would tangibly perceive a health 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. A 2010 Bone and Joint Journal paper from Oxford and 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 two-thirds of these. A 2016, 100-patient clinical trial (WHITE1) showed a 0% XHS reoperation rate versus a 6% SHS 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 approval 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 Orthopaedics' 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.
Contact details
Brian Thornes, CEO X-Bolt Orthopaedics
brian@x-bolt.com
Katja Stout, Scius Communications - for media
katja@sciuscommunications.com
About X-Bolt Orthopaedics
https://www.x-bolt.com/
X-BOLT Orthopaedics is an Irish medical device company that has developed a highly innovative range of hip fracture and long bone trauma solutions, noted for their strength and ease-of-use, quicker and better recovery for patients and cost savings for hospitals.
The X-BOLT "expanding bolt" systems improve anchorage in trabecular bone and allow greater confidence to fully weight bear post-op. X-BOLT has strong scientific evidence and regulatory approvals including with the FDA.
Founded and led by Dr. Brian Thornes, a surgeon with extensive development experience having previously invented, developed and licensed the ankle syndesmosis "TightRope" device to Arthrex, Inc (Naples, FL) in 2003, which has set the new gold standard for ankle syndesmosis injuries.
The X-BOLT devices, in stainless steel or titanium, are adaptable for other areas such as the spine, femur and humerus. Additional products include the Pendulum humeral nail, the Springboard tibial nail, the Karibu femoral nail, and the curved Metro jig with flexi-chain drive allowing surgeons to operate 'around a corner'.
Of the $7.2Bn worldwide trauma market, hip fixation comprises 9% and long bone IM nails comprise 11%. (ONN Trauma Report 2019)
