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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
109
TKR (Vanguard Total Knee System, Biomet) with PSPG (Signature, Materialise) technique
TKR (Vanguard Total Knee System, Biomet) with Conventional Technique
Vestre Viken HF
Drammen, Buskerud, Norway
Center for Implant and Radiostereometric Research Oslo, Oslo University Hospital
Oslo, Olso, Norway
Sykehuset Telemark
Skien, Telemark, Norway
Betanien Hospital Skien
Skien, Telemark, Norway
Assessing total knee implant positioning using PSPG compared with the conventional method in TKR
Measurement of knee implant positioning by using the CT Perth protocol
Time frame: 3 months
Clinical Functional Result
KOOS (Knee injury and Osteoarthritis Outcome Score), American knee society score, EQ-5D and pain score (NRS) will be registered pre-operatively, after 3 months and after 1 and 2 years. Scores of the 2 groups will be compared.
Time frame: 2 yrs
Operating Time
Time frame: 1 day
Component Stability
RSA
Time frame: 2 yrs
Cost to Benefit from a Health Economic Perspective
Cost-benefit analysis
Time frame: 1 year
X-ray analysis
Standing HKA (Hip, Knee, Ankle-long axis images): preoperatively and after 3 months. If there is a extension deficit a X-HKA will be performed 12 months postoperatively. X-ray front, side and patella 'sky view' will be taken pre-operatively, postoperative day 3, after 5 and 10 years. Alignment and possible osteolytic development will be recorded in both groups.
Time frame: 10 yrs
Perioperative Morbidity
Time frame: 1 week
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