NCT02905097

Brief Summary

The aim of the study is to assess the performance of the cementless Triathlon Tritanium tibial baseplate for total knee replacement, with a minimum follow up of 5 years.

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
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2018

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

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

First Submitted

Initial submission to the registry

September 14, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 19, 2016

Completed
1.3 years until next milestone

Study Start

First participant enrolled

January 5, 2018

Completed
6.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2024

Completed
Last Updated

July 18, 2019

Status Verified

July 1, 2019

Enrollment Period

6.6 years

First QC Date

September 14, 2016

Last Update Submit

July 17, 2019

Conditions

Arthritis

Keywords

Knee arthroplasty, TotalKnee replacement, TotalSurvival rateOsseointegrationGait

Outcome Measures

Primary Outcomes (1)

  • Implant survival at five years

    Kaplan-Meier implant survival at 5 years

    5 years

Secondary Outcomes (18)

  • Component loosening rate

    5 years

  • Fracture rate

    5 years

  • Infection rate

    5 years

  • Radiolucency

    review at 6 weeks, 6 months, 1 and 5 years

  • Bone quality

    review at 6 weeks, 6 months, 1 and 5 years

  • +13 more secondary outcomes

Study Arms (1)

Arthroplasty cohort

A cohort of patients who will undergo knee replacement surgery and will receive Triathlon Tritanium (cementless) tibial implant.

Procedure: Knee Replacement

Interventions

Knee ReplacementPROCEDURE

Surgical replacement of arthritic knee with an implant

Also known as: Knee Arthroplasty
Arthroplasty cohort

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients who have been referred to the Golden Jubilee National Hospital for total knee replacement.

You may qualify if:

  • Unilateral TKA
  • Age 18-75 years
  • BMI \<40
  • From one of the following health boards: Ayrshire \& Arran, Forth Valley, Greater Glasgow \& Clyde, Highland, Lanarkshire or Lothian
  • Suitable to receive the study implant

You may not qualify if:

  • Revision of existing knee replacement
  • Previous hip or knee replacement surgery if within the last 12 months
  • Previous ankle surgery
  • Diagnosed osteopenia or osteoporosis
  • Proximal tibial bone defects
  • Unable to give informed consent
  • Unwilling to take part
  • Unable to return to the Golden Jubilee National Hospital for followup appointments

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Golden Jubilee National Hospital

Clydebank, West Dunbartonshire, G81 4dy, United Kingdom

Location

Related Publications (22)

  • Kim YH, Park JW, Lim HM, Park ES. Cementless and cemented total knee arthroplasty in patients younger than fifty five years. Which is better? Int Orthop. 2014 Feb;38(2):297-303. doi: 10.1007/s00264-013-2243-4. Epub 2014 Jan 14.

    PMID: 24420155BACKGROUND

  • Aprato A, Risitano S, Sabatini L, Giachino M, Agati G, Masse A. Cementless total knee arthroplasty. Ann Transl Med. 2016 Apr;4(7):129. doi: 10.21037/atm.2016.01.34.

    PMID: 27162779BACKGROUND

  • Lombardi AV Jr, Berasi CC, Berend KR. Evolution of tibial fixation in total knee arthroplasty. J Arthroplasty. 2007 Jun;22(4 Suppl 1):25-9. doi: 10.1016/j.arth.2007.02.006.

    PMID: 17570273BACKGROUND

  • Naudie DD, Ammeen DJ, Engh GA, Rorabeck CH. Wear and osteolysis around total knee arthroplasty. J Am Acad Orthop Surg. 2007 Jan;15(1):53-64. doi: 10.5435/00124635-200701000-00006.

    PMID: 17213382BACKGROUND

  • Bassett RW. Results of 1,000 Performance knees: cementless versus cemented fixation. J Arthroplasty. 1998 Jun;13(4):409-13. doi: 10.1016/s0883-5403(98)90006-7.

    PMID: 9645521BACKGROUND

  • Albrektsson BE, Carlsson LV, Freeman MA, Herberts P, Ryd L. Proximally cemented versus uncemented Freeman-Samuelson knee arthroplasty. A prospective randomised study. J Bone Joint Surg Br. 1992 Mar;74(2):233-8. doi: 10.1302/0301-620X.74B2.1544959.

    PMID: 1544959BACKGROUND

  • Berry DJ, Wold LE, Rand JA. Extensive osteolysis around an aseptic, stable, uncemented total knee replacement. Clin Orthop Relat Res. 1993 Aug;(293):204-7.

    PMID: 8339482BACKGROUND

  • De Martino I, D'Apolito R, Sculco PK, Poultsides LA, Gasparini G. Total Knee Arthroplasty Using Cementless Porous Tantalum Monoblock Tibial Component: A Minimum 10-Year Follow-Up. J Arthroplasty. 2016 Oct;31(10):2193-8. doi: 10.1016/j.arth.2016.03.057. Epub 2016 Apr 12.

    PMID: 27172865BACKGROUND

  • Harwin SF, Kester MA, Malkani AL, Manley MT. Excellent fixation achieved with cementless posteriorly stabilized total knee arthroplasty. J Arthroplasty. 2013 Jan;28(1):7-13. doi: 10.1016/j.arth.2012.06.006. Epub 2012 Jul 31.

    PMID: 22854342BACKGROUND

  • Melton JT, Mayahi R, Baxter SE, Facek M, Glezos C. Long-term outcome in an uncemented, hydroxyapatite-coated total knee replacement: a 15- to 18-year survivorship analysis. J Bone Joint Surg Br. 2012 Aug;94(8):1067-70. doi: 10.1302/0301-620X.94B8.28350.

    PMID: 22844047BACKGROUND

  • Tai CC, Cross MJ. Five- to 12-year follow-up of a hydroxyapatite-coated, cementless total knee replacement in young, active patients. J Bone Joint Surg Br. 2006 Sep;88(9):1158-63. doi: 10.1302/0301-620X.88B9.17789.

    PMID: 16943464BACKGROUND

  • Bagsby DT, Issa K, Smith LS, Elmallah RK, Mast LE, Harwin SF, Mont MA, Bhimani SJ, Malkani AL. Cemented vs Cementless Total Knee Arthroplasty in Morbidly Obese Patients. J Arthroplasty. 2016 Aug;31(8):1727-31. doi: 10.1016/j.arth.2016.01.025. Epub 2016 Jan 29.

    PMID: 26895823BACKGROUND

  • Mont MA, Pivec R, Issa K, Kapadia BH, Maheshwari A, Harwin SF. Long-term implant survivorship of cementless total knee arthroplasty: a systematic review of the literature and meta-analysis. J Knee Surg. 2014 Oct;27(5):369-76. doi: 10.1055/s-0033-1361952. Epub 2013 Dec 7.

    PMID: 24318196BACKGROUND

  • Fricka KB, Sritulanondha S, McAsey CJ. To Cement or Not? Two-Year Results of a Prospective, Randomized Study Comparing Cemented Vs. Cementless Total Knee Arthroplasty (TKA). J Arthroplasty. 2015 Sep;30(9 Suppl):55-8. doi: 10.1016/j.arth.2015.04.049. Epub 2015 Jun 3.

    PMID: 26118567BACKGROUND

  • Khaw FM, Kirk LM, Morris RW, Gregg PJ. A randomised, controlled trial of cemented versus cementless press-fit condylar total knee replacement. Ten-year survival analysis. J Bone Joint Surg Br. 2002 Jul;84(5):658-66. doi: 10.1302/0301-620x.84b5.12692.

    PMID: 12188480BACKGROUND

  • Matassi F, Carulli C, Civinini R, Innocenti M. Cemented versus cementless fixation in total knee arthroplasty. Joints. 2014 Jan 8;1(3):121-5. eCollection 2013 Jul-Sep.

    PMID: 25606521BACKGROUND

  • Meneghini RM, Mont MA, Backstein DB, Bourne RB, Dennis DA, Scuderi GR. Development of a Modern Knee Society Radiographic Evaluation System and Methodology for Total Knee Arthroplasty. J Arthroplasty. 2015 Dec;30(12):2311-4. doi: 10.1016/j.arth.2015.05.049. Epub 2015 May 29.

    PMID: 26122112BACKGROUND

  • Potter GD 3rd, Abdel MP, Lewallen DG, Hanssen AD. Midterm Results of Porous Tantalum Femoral Cones in Revision Total Knee Arthroplasty. J Bone Joint Surg Am. 2016 Aug 3;98(15):1286-91. doi: 10.2106/JBJS.15.00874.

    PMID: 27489319BACKGROUND

  • Murray DW, Fitzpatrick R, Rogers K, Pandit H, Beard DJ, Carr AJ, Dawson J. The use of the Oxford hip and knee scores. J Bone Joint Surg Br. 2007 Aug;89(8):1010-4. doi: 10.1302/0301-620X.89B8.19424.

    PMID: 17785736BACKGROUND

  • Conner-Spady BL, Marshall DA, Bohm E, Dunbar MJ, Loucks L, Al Khudairy A, Noseworthy TW. Reliability and validity of the EQ-5D-5L compared to the EQ-5D-3L in patients with osteoarthritis referred for hip and knee replacement. Qual Life Res. 2015 Jul;24(7):1775-84. doi: 10.1007/s11136-014-0910-6. Epub 2015 Jan 3.

    PMID: 25555837BACKGROUND

  • Ko V, Naylor JM, Harris IA, Crosbie J, Yeo AE. The six-minute walk test is an excellent predictor of functional ambulation after total knee arthroplasty. BMC Musculoskelet Disord. 2013 Apr 24;14:145. doi: 10.1186/1471-2474-14-145.

    PMID: 23617377BACKGROUND

  • Jenkins S, Cecins N, Camarri B, Williams C, Thompson P, Eastwood P. Regression equations to predict 6-minute walk distance in middle-aged and elderly adults. Physiother Theory Pract. 2009 Oct;25(7):516-22. doi: 10.3109/09593980802664711.

    PMID: 19925174BACKGROUND

MeSH Terms

Conditions

Arthritis

Interventions

Arthroplasty, Replacement, Knee

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Arthroplasty, ReplacementArthroplastyOrthopedic ProceduresSurgical Procedures, OperativePlastic Surgery ProceduresProsthesis Implantation

Study Officials

  • Nicholas Ohly, MBBS, FRCSEd

    nick.ohly@gjnh.scot.nhs.uk

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 14, 2016

First Posted

September 19, 2016

Study Start

January 5, 2018

Primary Completion

August 1, 2024

Study Completion

August 1, 2024

Last Updated

July 18, 2019

Record last verified: 2019-07

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)