Gonarthritis Clinical Trial
Official title:
Patient-specific Positioning Guides (PSPG) Technique Versus Conventional Technique in Total Knee Arthroplasty - a Prospective Randomized Study.
A Prospective, randomized, clinical controlled study comparing conventional knee arthroplasty and the Patient-specific positioning guides (PSPG) (Signature Patient Care, Materialise) using the Vanguard Total Knee System (Biomet)
Background: Use of PSPG in TKR is a relative new technique and already widely used. PSPG,
based on MRI data, fit directly into the patient's anatomy and enable total knee replacement
without use of traditional invasive instrumentation. Data showing extra benefit of this
technique compared to conventional TKR technique are not widely available.
Aim: To determine the safety of this new surgical technique compared to conventional TKR and
whether a clinical, functional and financial benefit can be achieved.
Methods: 200 patients with primary osteoarthritis will be randomized to 2 groups. 30
patients in each group will be included in the RSA section of the study. Participating
hospitals UOS Ullevål, Vestre Viken, Sykehuset Telemark and Betanien Hospital Skien.
Inclusion started Aug. 2011. Clinical scoring: KSS, KOOS, EQ-5D and VAS will be examined at
inclusion, after 3 months, and at the 1 and 2 year control. RSA before discharge on day 2, 3
months, 1 year, 2 years. RSA images will be sent blinded to CIRRO (Center for Implant and
Radiostereometric Research Oslo Orthopaedic Centre, Oslo University Hospital) for image
analysis. Standing HKA: preoperatively and after 3 months. X-ray will be taken
pre-operatively, postoperative day 3, after 3 months and after 5 and 10 years. CT Perth
after 3 months for measuring alignment. A cost-benefit analysis will be performed.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT02748291 -
An Investigation Into the Role of Walking in Treating the Symptoms of Knee Osteoarthritis: The WalkOut Study
|
N/A |