Patient-specific Positioning Guides (PSPG) Technique Versus Conventional Technique in Total Knee Arthroplasty
NCT ID: NCT01696552
Last Updated: 2017-03-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
109 participants
INTERVENTIONAL
2011-09-30
2024-01-31
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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TKR with Positioning Guides (PSPG)
Use of PSPG (Signature, Materialise) in TKR (Vanguard Total Knee System, Biomet)
TKR with Positioning Guides (PSPG)
TKR (Vanguard Total Knee System, Biomet) with PSPG (Signature, Materialise) technique
TKR with Conventional Technique
TKR (Vanguard Total Knee System, Biomet), Conventional Technique
TKR with Conventional Technique
TKR (Vanguard Total Knee System, Biomet) with Conventional Technique
Interventions
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TKR with Positioning Guides (PSPG)
TKR (Vanguard Total Knee System, Biomet) with PSPG (Signature, Materialise) technique
TKR with Conventional Technique
TKR (Vanguard Total Knee System, Biomet) with Conventional Technique
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Informed consent
Exclusion Criteria
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
18 Years
ALL
No
Sponsors
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Betanien Hospital
OTHER
Sykehuset Telemark
OTHER_GOV
Vestre Viken Hospital Trust
OTHER
Oslo University Hospital
OTHER
Responsible Party
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Stephan M Rohrl
Principal Investigator
Principal Investigators
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Stephan M Röhrl, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Oslo Univerity Hospital, Oslo, Norway
Justin van Leeuwen, MD
Role: PRINCIPAL_INVESTIGATOR
Betanien Hospital Skien, Skien, Norway
Bjarne Grøgaard, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Oslo University Hospital, Oslo, Norway
Finnur Snorrason, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Vestre Viken HF, Drammen Hospital, Drammen, Norway
Hilde Apold, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Sykehuset Telemark
Locations
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Vestre Viken HF
Drammen, Buskerud, Norway
Center for Implant and Radiostereometric Research Oslo, Oslo University Hospital
Oslo, Olso, Norway
Sykehuset Telemark
Skien, Telemark, Norway
Betanien Hospital Skien
Skien, Telemark, Norway
Countries
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References
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Valstar ER, Gill R, Ryd L, Flivik G, Borlin N, Karrholm J. Guidelines for standardization of radiostereometry (RSA) of implants. Acta Orthop. 2005 Aug;76(4):563-72. doi: 10.1080/17453670510041574.
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. doi: 10.1302/0301-620x.86b6.15456.
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. doi: 10.1097/00003086-200111000-00041.
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.
Karrholm J, Borssen B, Lowenhielm 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, Dansgard F, Herberts P, Lindstrand A, Regner 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. doi: 10.2106/JBJS.F.00386.
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. doi: 10.2106/JBJS.D.02945.
Lutzner J, Krummenauer F, Wolf C, Gunther 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. doi: 10.1177/230949900601400111.
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. doi: 10.1302/0301-620X.87B11.16474.
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. doi: 10.1302/0301-620X.88B11.17986.
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.
Related Links
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Study description on website: Center for Implant and Radiostereometric Research Oslo - Oslo University Hospital
Other Identifiers
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2010/2056
Identifier Type: OTHER
Identifier Source: secondary_id
2011/7613
Identifier Type: -
Identifier Source: org_study_id
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