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| ID | Type | Description | Link |
|---|---|---|---|
| 2010/2056 | Other Identifier | Regional Committee for Medical Health Research Ethics West |
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| Name | Class |
|---|---|
| Betanien Hospital | OTHER |
| Sykehuset Telemark | OTHER_GOV |
| Vestre Viken Hospital Trust | OTHER |
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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)
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TKR with Positioning Guides (PSPG) | Active Comparator | Use of PSPG (Signature, Materialise) in TKR (Vanguard Total Knee System, Biomet) |
|
| TKR with Conventional Technique | Active Comparator | TKR (Vanguard Total Knee System, Biomet), Conventional Technique |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TKR with Positioning Guides (PSPG) | Procedure | TKR (Vanguard Total Knee System, Biomet) with PSPG (Signature, Materialise) technique |
|
| Measure | Description | Time Frame |
|---|---|---|
| Assessing total knee implant positioning using PSPG compared with the conventional method in TKR | Measurement of knee implant positioning by using the CT Perth protocol | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Functional Result | 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. | 2 yrs |
| Operating Time |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stephan M Röhrl, MD, PhD | Oslo Univerity Hospital, Oslo, Norway | Principal Investigator |
| Justin van Leeuwen, MD | Betanien Hospital Skien, Skien, Norway | Principal Investigator |
| Bjarne Grøgaard, MD, PhD | Oslo University Hospital, Oslo, Norway | Principal Investigator |
| Finnur Snorrason, MD, PhD | Vestre Viken HF, Drammen Hospital, Drammen, Norway | Principal Investigator |
| Hilde Apold, MD, PhD | Sykehuset Telemark | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vestre Viken HF | Drammen | Buskerud | 3004 | Norway | ||
| Center for Implant and Radiostereometric Research Oslo, Oslo University Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16195075 | Background | 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. | |
| 8119010 | Background | 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. |
| Label | URL |
|---|---|
| Study description on website: Center for Implant and Radiostereometric Research Oslo - Oslo University Hospital | View source |
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| ID | Term |
|---|---|
| C060335 | tokaratoxin 2 |
| D002927 | Cimetidine |
| D020816 | Amino Acid Motifs |
| ID | Term |
|---|---|
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
| D007093 | Imidazoles |
| D001393 |
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|
| TKR with Conventional Technique | Procedure | TKR (Vanguard Total Knee System, Biomet) with Conventional Technique |
|
|
| 1 day |
| Component Stability | RSA | 2 yrs |
| Cost to Benefit from a Health Economic Perspective | Cost-benefit analysis | 1 year |
| X-ray analysis | 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. | 10 yrs |
| Perioperative Morbidity | 1 week |
| Oslo |
| Olso |
| 0407 |
| Norway |
| Sykehuset Telemark | Skien | Telemark | 3710 | Norway |
| Betanien Hospital Skien | Skien | Telemark | 3722 | Norway |
| 15330021 | Background | 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. |
| 18165024 | Background | 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. |
| 11716402 | Background | 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. |
| 21809150 | Background | 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. |
| 7983118 | Background | 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. |
| 7744919 | Background | 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. |
| 17272435 | Background | 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. |
| 16203894 | Background | 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. |
| 18669959 | Background | 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. |
| 16598087 | Background | 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. |
| 16260662 | Background | 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. |
| 19195896 | Background | 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. |
| 17075100 | Background | 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. |
| 18383407 | Background | 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. |
| Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D000072416 | Protein Structural Elements |
| D011487 | Protein Conformation |
| D008968 | Molecular Conformation |
| D015394 | Molecular Structure |
| D001669 | Biochemical Phenomena |
| D055598 | Chemical Phenomena |
| D017433 | Protein Structure, Secondary |