Patient-specific Positioning Guides (PSPG) Technique Versus Conventional Technique in Total Knee Arthroplasty
Patient-specific Positioning Guides (PSPG) Technique Versus Conventional Technique in Total Knee Arthroplasty
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.
Inclusion Criteria:

 1. Man and women elder than 18 years old with knee osteoarthritis

 2. Informed consent

 Exclusion Criteria:

 1. Active infection.

 2. Under 50 years.

 3. Revision arthroplasty.

 4. Marked bone loss which could preclude adequate fixation of the device.

 5. Non-cooperative subjects.

 6. Parkinson's Disease or other neurologic and muscular disorders

 7. Severe vascular insufficiency of the affected limb.

 8. Severe instability or deformity of the ligaments and / or surrounding soft tissue
 which may preclude stability of the device.

 9. Paget's disease

 10. Rheumatoid Arthritis and other systemic diseases

 11. Patients with rigid hip joints

 12. Known metal allergy

 13. Patients can only join the study with 1 operated knee arthroplasty