None listed
Conditions
Brief summary
This clinical study is a single centre, prospective, randomized, participant-blinded trial enrolling 40 patients to receive either a Cementless Neck Preserving stem or a Conventional Hip stem Prosthesis. Neck preserving prostheses to offer a more physiological load transmission across the femur, the nature of achieving a stable press-fit means that the stem must adapt to the geometry of the bone. As patient anatomy is highly variable, there is limited ability to adjust the femoral offset, centre of rotation, femoral anteversion and leg length. It is unclear whether anatomical restoration, offered by neck preserving prostheses is comparable to conventional prostheses. The success of the neck preserving systems relies on the precise positioning and sizing of the implant and the excellent long-term durability of the ceramic bearings. Hence, we propose a randomized comparative study to assess and compare the anatomical head centre, gait analysis and bone remodelling of two parallel groups receiving either a Neck preserving or a Conventional hip stem prosthesis by the direct anterior approach. Antero-posterior and modified Budin x-rays will be analysed at preoperatively, 3 months, 12 months, 2 years and 5 years to assess femoral head offset, stem orientation and leg length. DEXA (bone density) scans will be assessed pre-operatively and 12 months to measure femoral bone density, with the aim of assessing bone remodelling after total hip replacement. Spatial-Temporal gait analysis will be used to quantify measurement of standard gait (6 minute walking test – 6MWT) and sit-to-stand preoperatively, 3 months and 12 months. Standard, functional parameters will be assessed pre-operatively, 3 months, 12 months, 2 years and 5 years.
Interventions
Sponsors
Study design
Eligibility
Inclusion criteria
1. Eligible for a primary total hip replacement 2. Dorr type A femur 3. Willing to comply with the protocol 4. Willing and competent to consent
Exclusion criteria
1. Not meeting the inclusion criteria 2. Any patient with a revision / resurfacing or a hemi hip replacement 3. Patients with a Dorr type B or C femur 4. Cemented hip replacement 5. Medically Unfit for surgery 6. Not willing to comply with the protocol 7. Not willing or competent to consent