Conducted by the Oxford Clinical Trials Research Unit (OCTRU), and published in The Bone and Joint Journal, the trial compared the effectiveness of two different implants used to treat broken hips but found no clinically relevant difference between treatments.
The sliding hip screw (SHS) is a well-established treatment for hip fractures. A screw and plate is inserted into the thigh bone around the hip joint to hold the hip in place, leading to successful bone healing. However, in some patients, osteoporosis weakens the bones meaning they are not strong enough for the screw to hold in place. The broken bones can then come apart leaving some patients needing a second operation.
A new type of implant, the X-Bolt (XHS), was tested against the SHS to see if it was more effective. The X-Bolt builds on the successful design features of the SHS, the main difference being a bolt that expands within the femoral head, compressing the surrounding bone to improve fixation.
The trial recruited 1128 people, aged 60+ years who were being treated for a hip fracture. Participants were randomised into two groups, with half treated with the SHS implant, the other half with the X-Bolt. The primary outcome measure was health-related quality of life (HRQoL) measured at four months, collected through patient questionnaires and review of the medical records.
The trial found that any difference in four-month health-related quality of life between the two implants was small and probably not clinically important. The risk of needing a second operation was approximately 3% in both groups.
Professor Xavier Griffin, who led the research said: “The two implants perform equally well in terms of patient outcomes. The revision surgery risk was low in both arms indicating that the UK treatment systems are working well. We concluded that surgeons should choose the implant that they are most familiar with or prefer to use.”
Hip fractures remain a huge challenge for the medical community and are the most common injury in older people that requires treatment in hospital. There were an estimated nine million osteoporotic fractures globally in 2000, of which 1.6 million were hip fractures. With aging populations these figures are set to increase. The socioeconomic cost is estimated at 5.8 million disability adjusted life years lost and represents 1.75% of the total healthcare burden in established market economies.
The study was funded by X-Bolt Ltd and was supported by the National Institute for Health Research Oxford Biomedical Research Centre.