None listed
Conditions
Brief summary
Background Uncemented stems in primary total hip replacement (THR) are increasingly popular. The purported benefits of uncemented primary THR relate to improved stability and less side effects of cement implantation. However, concerns remain with the use of uncemented press-fit stems in primary THR. Methods From 2013-15, a total of 98 consecutive participants (100 primary THR procedures) were inducted into a single-institution, single-blinded, randomised clinical trial assessing, with radiostereometric analysis, whether autologous impaction bone grafting in uncemented primary THR reduced femoral component migration compared with traditional uncemented primary THR technique. Secondary outcomes comparing the two techniques were postoperative proximal femoral bone density (using dual-energy X-ray absorptiometry), function and quality of life (using Oxford Hip Score and Short Form-12 Health Survey), patient satisfaction, and hip pain (using visual rating scale). Results There was no difference in femoral component stability between the Graft and No Graft Groups at 2-years (p>0.5). There was no difference in calcar resorption between the Graft and No Graft Groups at 2-years (p>0.16), with both groups experiencing calcar bone loss. There was no difference in patient-reported pain, quality of life, function, or satisfaction postoperatively between the Graft and No Graft Groups at 2-years (p>0.3), with both groups improving in all measures. Conclusion Autologous impaction bone grafting in uncemented primary THR has shown its short-term postoperative outcomes to be on par with traditional uncemented technique. The next phase of research regarding this autologous impaction bone grafting technique will be to expand its application from Type-B femora into the elderly population with Type-C femora.
Interventions
Intervention: Uncemented primary total hip replacement (THR) with autologous impaction bone grafting.
Description: Uncemented primary total hip replacement involves surgical resection of the proximal femur and replacement with a prosthetic joint. The prosthetic components are press-fitted into place as opposed to being cemented, hence "uncemented". This is the same technique as standard uncemented primary total hip replacement, with the additional process of impacting bone graft into the f
Intervention: Uncemented primary total hip replacement (THR) with autologous impaction bone grafting. Description: Uncemented primary total hip replacement involves surgical resection of the proximal femur and replacement with a prosthetic joint. The prosthetic components are press-fitted into place as opposed to being cemented, hence "uncemented". This is the same technique as standard uncemented primary total hip replacement, with the additional process of impacting bone graft into the femoral canal prior to insertion and fitting of the femoral component. The bone graft is harvested from the resected femoral head. Duration: This additional process of harvesting, preparing, and impacting the autologous bone graft accounts for an additional 3-4 minutes of operative time. Bilateral Hips: Patients who went on to have a second contralateral THR received the same intervention as the first THR.
Sponsors
Riaz Khan
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject)
Eligibility
Sex/Gender
All
Age
60 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Inclusion Criteria 1. The individual clinically qualifies for total hip arthroplasty surgery based on physical examination and medical history. 2. The individual is diagnosed with an inflammatory or non inflammatory degenerative joint disease. 3. The individual has not had a previous total hip replacement or hip fusion of the affected hip joint. 4. The individual is physically and mentally willing and able to comply with postoperative scheduled clinical and radiographic evaluations and rehabilitation (i.e. not diagnosed with active significant psychiatric disorder, senile dementia, Alzheimer’s disease, presence of alcohol or substance abuse). 5. The individual is skeletally mature. 6. The individual has no plans to relocate to another geographic area before the completion of the study thus precluding scheduled follow-up.
Exclusion criteria
Exclusion Criteria 1. The individual is unable or unwilling to sign the Patient Informed Consent specific to this study. 2. The individual is less than 60 years of age. 3. The individual is classified as morbidly obese (body mass index 40 or greater). 4. The individual has an active infection within the considered hip joint. 5. Any condition where quality of bone graft from the femoral head is poor and therefore not able to be used (e.g. avascular necrosis). 6. The individual has a neuromuscular or neurosensory deficiency that limits the ability to evaluate the safety and effectiveness of the surgery. 7. The individual has a diagnosed systemic disease that would affect the subject’s welfare or overall outcome of the study (i.e. Paget's disease, renal osteodystrophy), is not immunologically suppressed, or receiving steroids in excess of physiologic dose requirements. 8. The individual is pregnant. 9. The individual is a prisoner.
Outcome results
None listed