None listed
Conditions
Brief summary
BACKGROUND Micromotion analysis supports effective cemented tibial component fixation in Total Knee Replacement (TKR) but a paucity of literature exists for medial pivot designs. This clinical study examined the tibial component micromotion and clinical scores in a second-generation medial pivot TKR. METHODS This prospective single-center clinical cohort trial involved 35 patients with a mean patient age of 71 years. Operations were performed by one experienced arthroplasty surgeon using the SAIPH implant (MatOrtho). All patients received fully cemented fixation with patella resurfacing. Other variables were standardized. Radiostereometric Analysis was performed at 6 weeks and 12 months to monitor tibial component behavior. The working hypothesis of this study is that the SAIPH tibial baseplate achieves stable fixation using bone cement in subjects undergoing TKR
Interventions
All patients underwent total knee arthroplasty with the Saiph implant system from Matortho, each surgery taking an estimated one hour. Follow up X-rays were performed at six weeks postoperative and at one and two years, each time taking approximately twenty minutes.
Sponsors
Fremantle Hospital and Health Service
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 99 Years
Healthy volunteers
No
Inclusion criteria
osteoarthritis
Exclusion criteria
Planned or actual pregnancy, prior ipsilateral arthroplasty surgery, diagnosed osteoporosis or osteopenia and medications associated with it such as bisphosphonates, corticosteroids and Protos
Outcome results
None listed