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OsteoarthritisPhase 4NCT00822640

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

A Phase 4 study testing Total Knee Arthroplasty in people with Osteoarthritis and Rheumatoid Arthritis, run by Aesculap AG at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 40 to 90 years
What is being tested?
Total Knee Arthroplasty
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
1 siteGermany
Study dates
Mar 2004to Jul 2008
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 to 90 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • Frank Lampe, MD

    Hamburg, 22081

Other trials in Germany

About this study

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

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.

Read the 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.

Being tested
Total Knee Arthroplasty
Keywords
Prosthesis Design, Range of Motion, Articular, Arthroplasty, Replacement, Knee
Medical subject headings
Osteoarthritis, Arthritis, Rheumatoid

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Total Knee ArthroplastyDevice

    Also called Columbus Knee Prosthesis

    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.

Study groups in NCT00822640
Study groupRoleWhat they receive
1ExperimentalColumbus Knee Prosthesis with rotating Platform
Receives: Device: Total Knee Arthroplasty
2Active comparatorColumbus Knee Prosthesis with fixed platform
Receives: Device: Total Knee Arthroplasty

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Knee Society Score

    Measured: 12 Months

Secondary outcomes (2)

  1. Oxford Score

    Measured: 12

  2. Range of Motion

    Measured: 12 Months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Jan 2009 (estimated)
  2. Study startMar 2004
  3. Primary completionJun 2007
  4. Study completionJul 2008

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
100 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00822640
Sponsor's protocol ID
AAG-G-H-0301
Status last verified
May 2013
First submitted
13 Jan 2009
Last updated
14 May 2013
Results posted
No
Data monitoring committee
No

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. doi: 10.1097/00003086-200107000-00008.

    PubMed 11451131

  • 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.

    PubMed 12439236

  • 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.

    PubMed 10819281

  • 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.

    PubMed 11716386

  • 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.

    PubMed 11372345

  • 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.

    PubMed 12763437

  • 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.

    PubMed 12468843

  • 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.

    PubMed 12439239

  • 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.

    PubMed 11605289

  • 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.

    PubMed 11716371

  • 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.

    PubMed 12585579

  • 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.

    PubMed 11730328

  • 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.

    PubMed 24929659

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Total Knee Arthroplasty in people with Osteoarthritis and Rheumatoid Arthritis, run by Aesculap AG at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 May 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Knee Society Score (time frame: 12 Months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00822640, which also lists 13 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2013.

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