Comparison of Rotating vs. Fixed Platform of the COLUMBUS Knee Prosthesis

Rheumatoid Arthritis Clinical Trial

Official title:

Clinical Outcome With Attention to Functional Results One Year After Fixed or Mobile Bearing Total Knee Replacement in a Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00822640
• Other study ID #: AAG-G-H-0301
• Status: Completed
• Phase: Phase 4
• First received: January 13, 2009
• Last updated: May 13, 2013
• Start date: March 2004
• Est. completion date: July 2008

Study information

• Verified date: May 2013
• Source: Aesculap AG
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: July 2008
• Est. primary completion date: June 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 90 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arthritis, Rheumatoid
• Osteoarthritis
• Post-traumatic; Arthrosis
• Rheumatoid Arthritis

Intervention

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.

Locations

Country	Name	City	State
Germany	Frank Lampe, MD	Hamburg

Sponsors (1)

Lead Sponsor	Collaborator
Aesculap AG

Country where clinical trial is conducted

Germany, 

References & Publications (12)

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. — View Citation

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

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. — View Citation

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. — View Citation

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

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. — View Citation

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. — View Citation

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. — View Citation

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]. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Knee Society Score		12 Months	No
Secondary	Oxford Score		12	No
Secondary	Range of Motion		12 Months	No