Apex Femoral Nail Study Commences at Cork University Hospital
January 31st 2024
OrthoXel has recently initiated a clinical study at Cork University Hospital to assess the efficacy of the Apex Femoral Nail, building on the success of the previous Apex Tibial Nail study. Both products feature our patented micromotion technology, allowing 1 mm axial micromotion with enhanced torsional stability.
Nonunion fractures pose challenges in orthopaedics, leading to prolonged disability, depression, and opioid use. The primary goal of the study is to compare Apex Femoral Nails with benchmark intramedullary nails, evaluating healing measures such as radiographic scores, CT assessments, time to union, return to work, pain, and functional outcomes.
The primary objective of this clinical study is to compare OrthoXel’s Apex Femoral Nails with commercially available benchmark intramedullary nails by assessing various quantitative measures of healing. The areas under assessment in the study include:
- Radiographic Union Score (RUS Score): Examined at 6, 12, 18, and 24 weeks post-surgery.
- Pain with Weight Bearing: Assessed during clinic visits at 6, 12, 18, and 24 weeks.
- Patient Self-administration of Numeric Rating Scale (NRS) for Pain
- Time to Union
- Callus Volume and Bone Mineral Density via CT
- Return to Work
- EuroQol Five Dimensions Questionnaire (EQ-5D-5L): Quality of life and physical function
- Use of Opioids, Supplements, Alcohol, Tobacco, or Vaping: Influence of these factors on the healing process.
The femoral study design is aligned with our previous study on Apex micromotion for accelerated tibial fracture healing. Tibial fracture patients treated with micromotion, exhibited zero nonunions and faster healing, particularly in higher-risk injuries with comorbidities.
Our dedication to innovation is evident in our commitment to rigorous clinical research, shaping the future of orthopaedic care. Upcoming 2024 studies in the US will further contribute to these advancements.
CUH Study Principal Investigator
OrthoXel Chief Medical Officer
Professor James Harty is a Professor of Orthopedic Surgery at UCC and is currently working across three institutions – Cork University Hospital, South infirmary Victoria University Hospital and the Bon Secours Hospital in Cork, Ireland. He has practiced orthopaedic surgery for over 17 years and is a Fellow of the Royal College of Surgeons in Ireland.
Professor Harty began his involvement with the OrthoXel team more than ten years ago having seen first-hand the challenges associated with long bone fracture nonunion and delayed union. He has been an integral contributor to the development of our product portfolio through regular consultations with our Engineering Team.
“I am delighted to see the Apex Femoral Nail build on the success previously experienced with the Apex Tibial Nail through the utilization of micromotion technology. This is a highly innovative novel nailing system and I am proud to be part of this continued revolutionization of fracture fixation.”