None listed
Conditions
Brief summary
Currently knee replacement surgery is performed using external jigs or a computer navigation system to guide bone cuts necessary to implant the metal and plastic prosthesis. The computer navigation system is considered the "gold standard" for guiding and evaluating the cuts. However, new technology as been developed that allows patient-specific instruments to be manufactured based on a pre-operative MRI scan and x-rays of the affected knee. These instruments should allow bone cuts and thus implants to be positioned more accurately. The current study will include 10 patients that have met the criteria for total knee replacement. The patients will require a pre-operative MRI and full-leg x-rays. Their surgery will be performed with the custom instrumentation. All bone cuts will be evaluated intra-operatively, using the computer navigation system. Any cut that is inappropriate will be revised using the standard, computer navigated instruments. The surgery will require approximately 2 hours. The patients will require a post-operative computer tomography [CT] scan and full-leg x-rays to evaluate the limb and implant alignment. These studies will be performed 6 weeks post-operatively. Otherwise, the recovery and post-operative follow-up will be unchanged from that expected for routine knee replacement surgery. Our hypothesis is that the patient-matched instrumentation will align the bone cuts, implants, and the mechanical axis of the limb at least as well as would be expected using external jigs or computer assisted surgery.
Interventions
Currently knee replacement surgery is performed using external jigs or a computer navigation system to guide bone cuts necessary to implant the metal and plastic prosthesis. The computer navigation system is considered the "gold standard" for guiding and evaluating the cuts. However, new technology as been developed that allows patient-specific instruments to be manufactured based on a pre-operative magnetic resonance imaging [MRI] scan and x-rays of the affected knee. These instruments shoul
Currently knee replacement surgery is performed using external jigs or a computer navigation system to guide bone cuts necessary to implant the metal and plastic prosthesis. The computer navigation system is considered the "gold standard" for guiding and evaluating the cuts. However, new technology as been developed that allows patient-specific instruments to be manufactured based on a pre-operative magnetic resonance imaging [MRI] scan and x-rays of the affected knee. These instruments should allow bone cuts and thus implants to be positioned more accurately. The current study will include 10 patients that have met the criteria for total knee replacement. The patients will require a pre-operative MRI and full-leg x-rays. Their surgery will be performed with the custom instrumentation. All bone cuts will be evaluated intra-operatively, using the computer navigation system. Any cut that is inappropriate will be revised using the standard, computer navigated instruments. The surgery will require approximately 2 hours. The patients will require a post-operative computed tomography [CT] scan and full-leg x-rays to evaluate the limb and implant alignment. These studies will be performed 6 weeks post-operatively. Otherwise, the recovery and post-operative follow-up will be unchanged from that expected for routine knee replacement surgery.
Sponsors
Sydney Orthopaedic Research Institute
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
50 Years to 90 Years
Healthy volunteers
Yes
Inclusion criteria
Patients with osteoarthritis of the knee.
Exclusion criteria
Medically unfit for elective surgery. Pregnancy. Prior arthroplasty or limb alignment surgery. Infection. Inflammatory arthritis.
Outcome results
None listed