Comparison of Rotating vs. Fixed Platform of the COLUMBUS Knee Prosthesis - Full Text View

Purpose

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.

Condition	Intervention	Phase
Osteoarthritis Rheumatoid Arthritis Post-traumatic; Arthrosis	Device: Total Knee Arthroplasty	Phase 4

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Clinical Outcome With Attention to Functional Results One Year After Fixed or Mobile Bearing Total Knee Replacement in a Randomized Controlled Trial

Resource links provided by NLM:

MedlinePlus related topics: Joint Disorders Knee Replacement Osteoarthritis Rheumatoid Arthritis

U.S. FDA Resources

Further study details as provided by Aesculap AG:

Primary Outcome Measures:

Knee Society Score [ Time Frame: 12 Months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Oxford Score [ Time Frame: 12 ] [ Designated as safety issue: No ]
Range of Motion [ Time Frame: 12 Months ] [ Designated as safety issue: No ]

Enrollment:	100
Study Start Date:	March 2004
Study Completion Date:	July 2008
Primary Completion Date:	June 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 Columbus Knee Prosthesis with rotating Platform	Device: Total Knee Arthroplasty 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. Other Name: Columbus Knee Prosthesis
Active Comparator: 2 Columbus Knee Prosthesis with fixed platform	Device: Total Knee Arthroplasty 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. Other Name: Columbus Knee Prosthesis

Detailed Description:

Mobile bearing tibial platform designs are advocated to improve functional results of total knee replacement (TKR), and to reduce wear in the longer term. This study investigates short term functional results with two patient groups who are systematically different in the fixed or mobile tibial bearing only.

Methods: 100 knees in 97 patients are stratified according to age and gender and randomized into two groups fixed bearing (FB) with 52 knees and mobile bearing (MB) with 48 knees. All 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 follow an identical rehabilitation regime. Physical examinations are performed in a double-blinded manner before the operation and three, six and twelve months thereafter, using the Oxford and Knee Society scoring systems.

Eligibility

Ages Eligible for Study:	40 Years to 90 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00822640

Locations

Germany
Frank Lampe, MD
Hamburg, Germany, 22081

Sponsors and Collaborators

Aesculap AG

Investigators

Principal Investigator:

Frank Lampe, MD

Schön Kliniken Klinikum Eilbek

More Information

Publications:

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.

Buechel FF Sr. Long-term followup after mobile-bearing total knee replacement. Clin Orthop Relat Res. 2002 Nov;(404):40-50.

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.

Callaghan JJ. Mobile-bearing knee replacement: clinical results: a review of the literature. Clin Orthop Relat Res. 2001 Nov;(392):221-5. Review.

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. Review.

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, Avon). 2003 Jun;18(5):410-8.

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.

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.

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. German. Erratum in: Z Orthop Ihre Grenzgeb 2002 Jul-Aug;140(4):460. Behrent R [corrected to Behrendt R].

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.

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.

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. Review.

Responsible Party:	Dr. med. Frank Lampe, Schön Kliniken, Klinikum Eilbek
ClinicalTrials.gov Identifier:	NCT00822640 History of Changes
Other Study ID Numbers:	AAG-G-H-0301
Study First Received:	January 13, 2009
Last Updated:	May 13, 2013
Health Authority:	Germany: Ethics Commission

Keywords provided by Aesculap AG:

Prosthesis Design
Range of Motion, Articular
Arthroplasty, Replacement, Knee

Additional relevant MeSH terms:

Arthritis
Arthritis, Rheumatoid
Joint Diseases
Osteoarthritis
Musculoskeletal Diseases

Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on May 22, 2013