NCT01696552

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 Study.

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 109 (estimated)
• Sponsor: Oslo University Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Gonarthritis

Interventions

Type	Name	Description
PROCEDURE	TKR with Positioning Guides (PSPG)	TKR (Vanguard Total Knee System, Biomet) with PSPG (Signature, Materialise) technique
PROCEDURE	TKR with Conventional Technique	TKR (Vanguard Total Knee System, Biomet) with Conventional Technique

Timeline

• Start date: 2011-09-01
• Primary completion: 2014-01-01
• Completion: 2024-01-01
• First posted: 2012-10-01
• Last updated: 2017-03-29

Locations

4 sites across 1 country: Norway