Clinical trial NCT01696552: Patient-specific Positioning Guides (PSPG) Technique Versus Conventional Technique in Total Knee Arthroplasty
Official title: Patient-specific Positioning Guides (PSPG) Technique Versus Conventional Technique in Total Knee Arthroplasty - a Prospective Randomized Study.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Gonarthritis
Keywords: Gonarthritis
TKR
Conventional
Positioning Guides
PSPG
CT Perth
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
Collaborators: name: Betanien Hospital
name: Sykehuset Telemark
name: Vestre Viken Hospital Trust
First posted: 2012-10-01
Enrollment: 109
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Assessing total knee implant positioning using PSPG compared with the conventional method in TKR
timeFrame: 3 months
Secondary outcomes:
measure: Clinical Functional Result
timeFrame: 2 yrs
measure: Operating Time
timeFrame: 1 day
measure: Component Stability
timeFrame: 2 yrs
measure: Cost to Benefit from a Health Economic Perspective
timeFrame: 1 year
measure: X-ray analysis
timeFrame: 10 yrs
measure: Perioperative Morbidity
timeFrame: 1 week
Other outcomes:
Locations:
city: Drammen
country: Norway
facility: Vestre Viken HF
state: Buskerud
city: Oslo
country: Norway
facility: Center for Implant and Radiostereometric Research Oslo, Oslo University Hospital
state: Olso
city: Skien
country: Norway
facility: Sykehuset Telemark
state: Telemark
city: Skien
country: Norway
facility: Betanien Hospital Skien
state: Telemark
Study officials:
affiliation: Oslo Univerity Hospital, Oslo, Norway
name: Stephan M Röhrl, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Betanien Hospital Skien, Skien, Norway
name: Justin van Leeuwen, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Oslo University Hospital, Oslo, Norway
name: Bjarne Grøgaard, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Vestre Viken HF, Drammen Hospital, Drammen, Norway
name: Finnur Snorrason, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Sykehuset Telemark
name: Hilde Apold, MD, PhD
role: PRINCIPAL_INVESTIGATOR
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