Patient-specific Positioning Guides (PSPG) Technique Versus Conventional Technique in Total Knee Arthroplasty
Information source: Oslo University Hospital
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Gonarthritis
Intervention: TKR with Positioning Guides (PSPG) (Procedure); TKR with Conventional Technique (Procedure)
Phase: N/A
Status: Recruiting
Sponsored by: Oslo University Hospital Official(s) and/or principal investigator(s): Stephan M Röhrl, MD, PhD, Principal Investigator, Affiliation: Oslo Univerity Hospital, Oslo, Norway Justin van Leeuwen, MD, Principal Investigator, Affiliation: Betanien Hospital Skien, Skien, Norway Bjarne Grøgaard, MD, PhD, Principal Investigator, Affiliation: Oslo University Hospital, Oslo, Norway Finnur Snorrason, MD, PhD, Principal Investigator, Affiliation: Vestre Viken HF, Drammen Hospital, Drammen, Norway Hilde Apold, MD, Principal Investigator, Affiliation: Sykehuset Telemark
Overall contact: Stephan M Röhrl, MD, PhD, Phone: +47-91502770, Email: s.m.rohrl@medisin.uio.no
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)
Clinical Details
Official title: Patient-specific Positioning Guides (PSPG) Technique Versus Conventional Technique in Total Knee Arthroplasty - a Prospective Randomized Study.
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Assessing total knee implant positioning using PSPG compared with the conventional method in TKR
Secondary outcome: Clinical Functional ResultOperating Time Component Stability Cost to Benefit from a Health Economic Perspective X-ray analysis Perioperative Morbidity
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
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Stephan M Röhrl, MD, PhD, Phone: +47-91502770, Email: s.m.rohrl@medisin.uio.no
Vestre Viken HF, Drammen, Buskerud 3004, Norway; Active, not recruiting
Center for Implant and Radiostereometric Research Oslo, Oslo University Hospital, Oslo, Olso 0407, Norway; Recruiting Stephan M Röhrl, MD, PhD, Phone: +47-91502770, Email: s.m.rohrl@medisin.uio.no Justin van Leeuwen, MD, Phone: +47-47337863, Email: jamjvanleeuwen@gmail.com Stephan M Röhrl, MD, PhD, Principal Investigator Bjarne Grøgaard, MD, PhD, Principal Investigator
Betanien Hospital Skien, Skien, Telemark 3722, Norway; Recruiting Justin van Leeuwen, MD, Phone: +47-337863, Email: jamjvanleeuwen@gmail.com Justin van Leeuwen, MD, Principal Investigator
Sykehuset Telemark, Skien, Telemark 3710, Norway; Recruiting Hilde Apold, MD, Phone: +47-95877179, Email: hilde.apold@sthf.no Hilde Apold, MD, Sub-Investigator
Additional Information
Related publications: Valstar ER, Gill R, Ryd L, Flivik G, Börlin N, Kärrholm J. Guidelines for standardization of radiostereometry (RSA) of implants. Acta Orthop. 2005 Aug;76(4):563-72. Ritter MA, Faris PM, Keating EM, Meding JB. Postoperative alignment of total knee replacement. Its effect on survival. Clin Orthop Relat Res. 1994 Feb;(299):153-6. Chauhan SK, Clark GW, Lloyd S, Scott RG, Breidahl W, Sikorski JM. Computer-assisted total knee replacement. A controlled cadaver study using a multi-parameter quantitative CT assessment of alignment (the Perth CT Protocol). J Bone Joint Surg Br. 2004 Aug;86(6):818-23. Klatt BA, Goyal N, Austin MS, Hozack WJ. Custom-fit total knee arthroplasty (OtisKnee) results in malalignment. J Arthroplasty. 2008 Jan;23(1):26-9. doi: 10.1016/j.arth.2007.10.001. Fehring TK, Odum S, Griffin WL, Mason JB, Nadaud M. Early failures in total knee arthroplasty. Clin Orthop Relat Res. 2001 Nov;(392):315-8. Ng VY, DeClaire JH, Berend KR, Gulick BC, Lombardi AV Jr. Improved accuracy of alignment with patient-specific positioning guides compared with manual instrumentation in TKA. Clin Orthop Relat Res. 2012 Jan;470(1):99-107. doi: 10.1007/s11999-011-1996-6. Kärrholm J, Borssén B, Löwenhielm G, Snorrason F. Does early micromotion of femoral stem prostheses matter? 4-7-year stereoradiographic follow-up of 84 cemented prostheses. J Bone Joint Surg Br. 1994 Nov;76(6):912-7. Ryd L, Albrektsson BE, Carlsson L, Dansgård F, Herberts P, Lindstrand A, Regnér L, Toksvig-Larsen S. Roentgen stereophotogrammetric analysis as a predictor of mechanical loosening of knee prostheses. J Bone Joint Surg Br. 1995 May;77(3):377-83. Matziolis G, Krocker D, Weiss U, Tohtz S, Perka C. A prospective, randomized study of computer-assisted and conventional total knee arthroplasty. Three-dimensional evaluation of implant alignment and rotation. J Bone Joint Surg Am. 2007 Feb;89(2):236-43. Siston RA, Patel JJ, Goodman SB, Delp SL, Giori NJ. The variability of femoral rotational alignment in total knee arthroplasty. J Bone Joint Surg Am. 2005 Oct;87(10):2276-80. Lützner J, Krummenauer F, Wolf C, Günther KP, Kirschner S. Computer-assisted and conventional total knee replacement: a comparative, prospective, randomised study with radiological and CT evaluation. J Bone Joint Surg Br. 2008 Aug;90(8):1039-44. doi: 10.1302/0301-620X.90B8.20553. Weinrauch P, Myers N, Wilkinson M, Dodsworth J, Fitzpatrick P, Whitehouse S. Comparison of early postoperative rehabilitation outcome following total knee arthroplasty using different surgical approaches and instrumentation. J Orthop Surg (Hong Kong). 2006 Apr;14(1):47-52. Kalairajah Y, Simpson D, Cossey AJ, Verrall GM, Spriggins AJ. Blood loss after total knee replacement: effects of computer-assisted surgery. J Bone Joint Surg Br. 2005 Nov;87(11):1480-2. Victor J, Van Doninck D, Labey L, Innocenti B, Parizel PM, Bellemans J. How precise can bony landmarks be determined on a CT scan of the knee? Knee. 2009 Oct;16(5):358-65. doi: 10.1016/j.knee.2009.01.001. Epub 2009 Feb 5. Henckel J, Richards R, Lozhkin K, Harris S, Rodriguez y Baena FM, Barrett AR, Cobb JP. Very low-dose computed tomography for planning and outcome measurement in knee replacement. The imperial knee protocol. J Bone Joint Surg Br. 2006 Nov;88(11):1513-8. Kim S. Changes in surgical loads and economic burden of hip and knee replacements in the US: 1997-2004. Arthritis Rheum. 2008 Apr 15;59(4):481-8. doi: 10.1002/art.23525.
Starting date: September 2011
Last updated: September 27, 2012
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