Gonarthritis
Conditions
Keywords
Gonarthritis, TKR, Conventional, Positioning Guides, PSPG, CT Perth
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.
Interventions
PROCEDURETKR with Positioning Guides (PSPG)
TKR (Vanguard Total Knee System, Biomet) with PSPG (Signature, Materialise) technique
PROCEDURETKR with Conventional Technique
TKR (Vanguard Total Knee System, Biomet) with Conventional Technique
Sponsors
Betanien Hospital
Sykehuset Telemark
Vestre Viken Hospital Trust
Oslo University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Assessing total knee implant positioning using PSPG compared with the conventional method in TKR | 3 months | Measurement of knee implant positioning by using the CT Perth protocol |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Operating Time | 1 day | — |
| Component Stability | 2 yrs | RSA |
| Clinical Functional Result | 2 yrs | 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. |
| X-ray analysis | 10 yrs | 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. |
| Perioperative Morbidity | 1 week | — |
| Cost to Benefit from a Health Economic Perspective | 1 year | Cost-benefit analysis |
Countries
Norway
Outcome results
None listed