None listed
Conditions
Brief summary
This research project sought to assess the migration patterns and rotational stability of two modular cementless femoral stems (K2 and Apex, Global Orthopaedic technology) used routinely for hip replacement surgery.
Interventions
This study will compare post-operative radiological and clinical outcomes in patients who undergo primary total hip replacement surgery, using two different modular cementless femoral stems (K2 and Apex stems).
K2 (Global Orthopaedic Technology, Sydney Australia) modular hip system’s geometry comprises a dual longitudinal taper with rectangular cross-section. The rationale is to provide axial stability through the dual longitudinal taper and rotational stability through compaction of cancellous
This study will compare post-operative radiological and clinical outcomes in patients who undergo primary total hip replacement surgery, using two different modular cementless femoral stems (K2 and Apex stems). K2 (Global Orthopaedic Technology, Sydney Australia) modular hip system’s geometry comprises a dual longitudinal taper with rectangular cross-section. The rationale is to provide axial stability through the dual longitudinal taper and rotational stability through compaction of cancellous bone and the contact between the femoral cortex and the corners of the stem. Apex (Global Orthopaedic Technology, Sydney Australia) modular hip system’s geometry comprises a modular titanium construction with circumferential proximal porous coating of the “fit and fill” body section. A standard posterior surgical approach will be employed for both stems, while surgical duration should not differ.
Sponsors
Global Orthopaedic Technology
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
21 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
Inclusion Criteria 1.The individual has signed a Patient Informed Consent, specific to this study, and approved by the Institutional Ethics Review Board. 2.The individual is between the ages of 21 and 75 years. 3.The individual clinically qualifies for total hip arthroplasty (THA) surgery based on physical examination and history. 4.The individual is diagnosed with a primary diagnosis of Non Inflammatory Degenerative Joint Disease (osteoarthritis, traumatic arthritis, avascular necrosis, slipped capital epiphysis, pelvic fracture, femoral fracture, failed fracture fixation or diastrophic variant). 5.The individual is physically and mentally willing and able to comply with postoperative scheduled clinical and radiographic evaluations and rehabilitation (i.e., not currently being treated for a psychiatric disorder, senile dementia, Alzheimer’s disease, presence of alcohol/substance abuse). 6.The individual is skeletally mature.
Exclusion criteria
Exclusion Criteria 1.The individual is classified as morbidly obese (>40 Body Mass Index). 2.The individual has an active infection within the affected hip joint. 3.The individual has a diagnosed systemic disease that would affect the subject’s welfare or overall outcome of the study (i.e., moderate to severe osteoporosis, Paget's disease, renal osteodystrophy), is immunologically suppressed, or receiving steroids in excess of physiologic dose requirements. 4.The individual is pregnant. 5.The individual is a prisoner. 6.The individual has plans to relocate to another geographic area before study completion.
Outcome results
None listed