Patient-specific Positioning Guides (PSPG) Technique Versus Conventional Technique in Total Knee Arthroplasty

Study Overview
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Brief Summary
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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)

Detailed Description
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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.

Official Title
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Patient-specific Positioning Guides (PSPG) Technique Versus Conventional Technique in Total Knee Arthroplasty - a Prospective Randomized Study.

Conditions
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Gonarthritis

Intervention / Treatment
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* Procedure: TKR with Positioning Guides (PSPG)
* Procedure: TKR with Conventional Technique


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Man and women elder than 18 years old with knee osteoarthritis Informed consent Exclusion Criteria: Active infection. Under 50 years. Revision arthroplasty. Marked bone loss which could preclude adequate fixation of the device. Non-cooperative subjects. Parkinson's Disease or other neurologic and muscular disorders Severe vascular insufficiency of the affected limb. Severe instability or deformity of the ligaments and / or surrounding soft tissue which may preclude stability of the device. Paget's disease Rheumatoid Arthritis and other systemic diseases Patients with rigid hip joints Known metal allergy Patients can only join the study with 1 operated knee arthroplasty

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: TKR with Positioning Guides (PSPG)<br>Use of PSPG (Signature, Materialise) in TKR (Vanguard Total Knee System, Biomet) | Procedure: TKR with Positioning Guides (PSPG)<br>* TKR (Vanguard Total Knee System, Biomet) with PSPG (Signature, Materialise) technique<br>* Other names: Signature, Materialise;|
| Active Comparator: TKR with Conventional Technique<br>TKR (Vanguard Total Knee System, Biomet), Conventional Technique | Procedure: TKR with Conventional Technique<br>* TKR (Vanguard Total Knee System, Biomet) with Conventional Technique<br>* Other names: Vanguard Total Knee System, Biomet;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 2 yrs | 
| Operating Time |  | 1 day | 
| Component Stability | RSA | 2 yrs | 
| Cost to Benefit from a Health Economic Perspective | Cost-benefit analysis | 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. | 10 yrs | 
| Perioperative Morbidity |  | 1 week | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Gonarthritis, TKR, Conventional, Positioning Guides, PSPG, CT Perth