NCT01696552

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)

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
109

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

4 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2011

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

August 19, 2012

Completed
1 month until next milestone

First Posted

Study publicly available on registry

October 1, 2012

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2014

Completed
10 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2024

Completed
Last Updated

March 29, 2017

Status Verified

March 1, 2017

Enrollment Period

2.3 years

First QC Date

August 19, 2012

Last Update Submit

March 27, 2017

Conditions

Gonarthritis

Keywords

GonarthritisTKRConventionalPositioning GuidesPSPGCT Perth

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (6)

  • Clinical Functional Result

    2 yrs

  • Operating Time

    1 day

  • Component Stability

    2 yrs

  • Cost to Benefit from a Health Economic Perspective

    1 year

  • X-ray analysis

    10 yrs

  • +1 more secondary outcomes

Study Arms (2)

TKR with Positioning Guides (PSPG)

ACTIVE COMPARATOR

Use of PSPG (Signature, Materialise) in TKR (Vanguard Total Knee System, Biomet)

Procedure: TKR with Positioning Guides (PSPG)

TKR with Conventional Technique

ACTIVE COMPARATOR

TKR (Vanguard Total Knee System, Biomet), Conventional Technique

Procedure: TKR with Conventional Technique

Interventions

TKR with Positioning Guides (PSPG)PROCEDURE

TKR (Vanguard Total Knee System, Biomet) with PSPG (Signature, Materialise) technique

Also known as: Vanguard Total Knee System, Biomet, Signature, Materialise
TKR with Positioning Guides (PSPG)
TKR with Conventional TechniquePROCEDURE

TKR (Vanguard Total Knee System, Biomet) with Conventional Technique

Also known as: Vanguard Total Knee System, Biomet
TKR with Conventional Technique

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Man and women elder than 18 years old with knee osteoarthritis
  • Informed consent

You may not qualify if:

  • Active infection.
  • Under 50 years.
  • Revision arthroplasty.
  • Marked bone loss which could preclude adequate fixation of the device.
  • Non-cooperative subjects.
  • Parkinson's Disease or other neurologic and muscular disorders
  • Severe vascular insufficiency of the affected limb.
  • Severe instability or deformity of the ligaments and / or surrounding soft tissue which may preclude stability of the device.
  • Paget's disease
  • Rheumatoid Arthritis and other systemic diseases
  • Patients with rigid hip joints
  • Known metal allergy
  • Patients can only join the study with 1 operated knee arthroplasty

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Vestre Viken HF

Drammen, Buskerud, 3004, Norway

Location

Center for Implant and Radiostereometric Research Oslo, Oslo University Hospital

Oslo, Olso, 0407, Norway

Location

Sykehuset Telemark

Skien, Telemark, 3710, Norway

Location

Betanien Hospital Skien

Skien, Telemark, 3722, Norway

Location

Related Publications (16)

  • 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.

    PMID: 16195075BACKGROUND

  • 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.

    PMID: 8119010BACKGROUND

  • 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.

    PMID: 15330021BACKGROUND

  • 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.

    PMID: 18165024BACKGROUND

  • 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.

    PMID: 11716402BACKGROUND

  • 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.

    PMID: 21809150BACKGROUND

  • 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.

    PMID: 7983118BACKGROUND

  • 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.

    PMID: 7744919BACKGROUND

  • 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.

    PMID: 17272435BACKGROUND

  • 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.

    PMID: 16203894BACKGROUND

  • 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.

    PMID: 18669959BACKGROUND

  • 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.

    PMID: 16598087BACKGROUND

  • 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.

    PMID: 16260662BACKGROUND

  • 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.

    PMID: 19195896BACKGROUND

  • 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.

    PMID: 17075100BACKGROUND

  • 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.

    PMID: 18383407BACKGROUND

Related Links

MeSH Terms

Interventions

tokaratoxin 2CimetidineAmino Acid Motifs

Intervention Hierarchy (Ancestors)

GuanidinesAmidinesOrganic ChemicalsImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsProtein Structural ElementsProtein ConformationMolecular ConformationMolecular StructureBiochemical PhenomenaChemical PhenomenaProtein Structure, Secondary

Study Officials

  • 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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 19, 2012

First Posted

October 1, 2012

Study Start

September 1, 2011

Primary Completion

January 1, 2014

Study Completion

January 1, 2024

Last Updated

March 29, 2017

Record last verified: 2017-03

Locations

NO(4)