None listed
Conditions
Brief summary
Total knee arthroplasty (TKA) is a common, successful and safe operation for people who have end-stage knee arthritis. Pain-free knee flexion or bend of 135 degrees or more with stability is the goal of TKA. There are substantial improvements in pain and function. However, a major problem that persists is that patients do not consistently achieve knee flexion or bend greater than 110 degrees. The need to improve surgical technique and prosthetic designs to provide better flexibility and function is therefore essential. Many designs are available and currently in use. This study involves the use of one of these designs; the Profix Total Knee System (Smith & Nephew, Inc.). This system gives the surgeon the option to implant the prosthesis onto the leg using either increased flexion or standard instruments. The instruments are used by the surgeon to ensure accurate placement of the prosthesis. The objective of this study is to compare knee flexion range of motion (ROM), pain and functional outcomes of patients after primary TKA with the Profix Total Knee System. The primary hypothesis is that patients who have Profix TKA’s implanted by the surgeon with increased flexion instruments will achieve significantly greater knee flexion than those implanted with standard instruments. The secondary hypothesis is that this increased knee flexion will allow improved functional ability with less pain and as a result better quality of life. The trial is a double blind study with patients, assessors and data analysts blinded to group allocation
Interventions
Sponsors
Study design
Eligibility
Inclusion criteria
Adults listed for total knee replacement at the Mater Adult Hospital, with a diagnosis of non-inflammatory degenerative joint disease, who will be available for follow-up evaluations for 2 years.
Exclusion criteria
Active local or systemic infection, patients undergoing revision knee or complex primary arthroplasty, patients who are to have bilateral knee arthroplasty or those who have had knee arthroplasty in the previous 12 months. Pre-existing severe osteoporosis, or any other systemic or metabolic disorders causing progressive deterioration of bone.