NCT00822640

Brief Summary

A population of 100 patients randomised to rotating and fixed PE inlays in the Columbus knee prosthesis received a navigated TKR. Knee Society Score as primary endpoint, Oxford Score, and postoperative ROM after one year will be compared.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Mar 2004

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

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

March 1, 2004

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2007

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2008

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

January 13, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 14, 2009

Completed
Last Updated

May 14, 2013

Status Verified

May 1, 2013

Enrollment Period

3.3 years

First QC Date

January 13, 2009

Last Update Submit

May 13, 2013

Conditions

OsteoarthritisRheumatoid ArthritisPost-traumatic; Arthrosis

Keywords

Prosthesis DesignRange of Motion, ArticularArthroplasty, Replacement, Knee

Outcome Measures

Primary Outcomes (1)

  • Knee Society Score

    12 Months

Secondary Outcomes (2)

  • Oxford Score

    12

  • Range of Motion

    12 Months

Study Arms (2)

1

EXPERIMENTAL

Columbus Knee Prosthesis with rotating Platform

Device: Total Knee Arthroplasty

2

ACTIVE COMPARATOR

Columbus Knee Prosthesis with fixed platform

Device: Total Knee Arthroplasty

Interventions

Total Knee ArthroplastyDEVICE

All patients receive the same posterior cruciate retaining implant but the tibial tray and bearing (B. Braun Aesculap Columbus CR and RP) by two experienced surgeons and will follow an identical rehabilitation regime.

Also known as: Columbus Knee Prosthesis
12

Eligibility Criteria

Age40 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Indication for elective TKA
  • agreement to participate in this study
  • Patient age between 40 and 90 years

You may not qualify if:

  • Malalignment of the knee to be operated of more than 20° varus or 15° valgus
  • Former operations on the concerned knee (except diagnostic or therapeutic arthroscopy with only meniscus refixation or cartilage smoothing)
  • Joint replacement of another joint of the same leg
  • Infections in the operated joint during the follow-up period
  • Thromboses during the follow-up period
  • Preoperative classification according to ASA 4, 5 or 6

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Frank Lampe, MD

Hamburg, 22081, Germany

Location

Related Publications (13)

  • Buechel FF Sr, Buechel FF Jr, Pappas MJ, D'Alessio J. Twenty-year evaluation of meniscal bearing and rotating platform knee replacements. Clin Orthop Relat Res. 2001 Jul;(388):41-50. doi: 10.1097/00003086-200107000-00008.

    PMID: 11451131BACKGROUND

  • Buechel FF Sr. Long-term followup after mobile-bearing total knee replacement. Clin Orthop Relat Res. 2002 Nov;(404):40-50. doi: 10.1097/00003086-200211000-00008.

    PMID: 12439236BACKGROUND

  • Callaghan JJ, Squire MW, Goetz DD, Sullivan PM, Johnston RC. Cemented rotating-platform total knee replacement. A nine to twelve-year follow-up study. J Bone Joint Surg Am. 2000 May;82(5):705-11.

    PMID: 10819281BACKGROUND

  • Callaghan JJ. Mobile-bearing knee replacement: clinical results: a review of the literature. Clin Orthop Relat Res. 2001 Nov;(392):221-5. doi: 10.1097/00003086-200111000-00027.

    PMID: 11716386BACKGROUND

  • Callaghan JJ, Insall JN, Greenwald AS, Dennis DA, Komistek RD, Murray DW, Bourne RB, Rorabeck CH, Dorr LD. Mobile-bearing knee replacement: concepts and results. Instr Course Lect. 2001;50:431-49.

    PMID: 11372345BACKGROUND

  • Catani F, Benedetti MG, De Felice R, Buzzi R, Giannini S, Aglietti P. Mobile and fixed bearing total knee prosthesis functional comparison during stair climbing. Clin Biomech (Bristol). 2003 Jun;18(5):410-8. doi: 10.1016/s0268-0033(03)00044-5.

    PMID: 12763437BACKGROUND

  • Chiu KY, Ng TP, Tang WM, Lam P. Bilateral total knee arthroplasty: One mobile-bearing and one fixed-bearing. J Orthop Surg (Hong Kong). 2001 Jun;9(1):45-50. doi: 10.1177/230949900100900109.

    PMID: 12468843BACKGROUND

  • Emerson RH Jr, Hansborough T, Reitman RD, Rosenfeldt W, Higgins LL. Comparison of a mobile with a fixed-bearing unicompartmental knee implant. Clin Orthop Relat Res. 2002 Nov;(404):62-70. doi: 10.1097/00003086-200211000-00011.

    PMID: 12439239BACKGROUND

  • Grodzki T, Haak H, Behrendt R, Merk H, Krauspe R. [Prospective randomized comparative study of early functional outcome of 2 knee joint endoprosthesis systems--rotation plateau versus fixed polyethylene inlay]. Z Orthop Ihre Grenzgeb. 2001 Sep-Oct;139(5):393-6. doi: 10.1055/s-2001-17980. German.

    PMID: 11605289BACKGROUND

  • Kim YH, Kook HK, Kim JS. Comparison of fixed-bearing and mobile-bearing total knee arthroplasties. Clin Orthop Relat Res. 2001 Nov;(392):101-15. doi: 10.1097/00003086-200111000-00013.

    PMID: 11716371BACKGROUND

  • Price AJ, Rees JL, Beard D, Juszczak E, Carter S, White S, de Steiger R, Dodd CA, Gibbons M, McLardy-Smith P, Goodfellow JW, Murray DW. A mobile-bearing total knee prosthesis compared with a fixed-bearing prosthesis. A multicentre single-blind randomised controlled trial. J Bone Joint Surg Br. 2003 Jan;85(1):62-7. doi: 10.1302/0301-620x.85b1.13233.

    PMID: 12585579BACKGROUND

  • Vertullo CJ, Easley ME, Scott WN, Insall JN. Mobile bearings in primary knee arthroplasty. J Am Acad Orthop Surg. 2001 Nov-Dec;9(6):355-64. doi: 10.5435/00124635-200111000-00001.

    PMID: 11730328BACKGROUND

  • Marques CJ, Daniel S, Sufi-Siavach A, Lampe F. No differences in clinical outcomes between fixed- and mobile-bearing computer-assisted total knee arthroplasties and no correlations between navigation data and clinical scores. Knee Surg Sports Traumatol Arthrosc. 2015 Jun;23(6):1660-8. doi: 10.1007/s00167-014-3127-x. Epub 2014 Jun 15.

    PMID: 24929659DERIVED

MeSH Terms

Conditions

OsteoarthritisArthritis, Rheumatoid

Interventions

Arthroplasty, Replacement, Knee

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Arthroplasty, ReplacementArthroplastyOrthopedic ProceduresSurgical Procedures, OperativePlastic Surgery ProceduresProsthesis Implantation

Study Officials

  • Frank Lampe, MD

    Schön Kliniken Klinikum Eilbek

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

January 13, 2009

First Posted

January 14, 2009

Study Start

March 1, 2004

Primary Completion

June 1, 2007

Study Completion

July 1, 2008

Last Updated

May 14, 2013

Record last verified: 2013-05

Locations

DE(1)