CClinicalTrials.gg
CompletedNCT00175136Updated Jan 4, 2023

A Comparison of the Design of Tibia Stems in Cemented Total Knee Arthroplasty - Wedge Stem Versus I-beam Stem.

An interventional study of Maxim TKA in Osteoarthritis, sponsored by University of Aarhus. Completed at 1 site in Denmark. Open to participants aged 70 Years and older. Per ClinicalTrials.gov, last updated 2023-01-04.

Sponsored by University of Aarhus · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
54
Allocation
Randomized
Ages
70 Years and older
Sex
All
01

Study summary

The purpose of this study is to compare the early migration and periprosthetic bone changes of two cemented total knee arthroplasties with different tibial stem design. Only the tibial prostheses plateau varies in that one is an wedge-shaped stem and the other is a I-shaped stem.

Read the detailed description

Around 4% of total knee arthroplasties (TKA) are revised 15 years after the primary operation, most due to loosening of the implant. About 70 % TKA are fixed with bone cement and in general the results after total knee arthroplasty are excellent and with the existing technique about 95% well functioning prostheses can be expected 10 years post surgery. The most serious late complication to surgery is aseptic loosening of the implants; and this remains one of the main courses of failure of both uncemented and cemented total knee implants.

Implant design, method of fixation and the bone mass density has a large influence on implant stability. Fixation of the tibia base plates in total knee arthroplasty can be obtained by different designs of anchorage in the tibia e.g. central round stems, fins and pegs. The smaller the tibia stem; the lesser amount of bone is lost at implantation and following revisions rendering probable a time gain before secondary arthrodesis is necessary. The tibia stem cannot be to tiny either because it has to be able to resist the load of shearing forces naturally presented by the knee kinetics.

In this project we are using modularly tibia components with a central wedge- and I-beam shaped stem respectively. Both type of prosthesis are consolidated in the bone by bone cement applied under the base-plate while the stem is fixed press-fit (without cement) in the proximal tibia.

The purpose of this study is to compare the early migration of two cemented total knee implants with different tibial stem design by RSA (radio stereophotogrammetric analysis). Furthermore, we will make research into the periprosthetic bone and it's changes after surgery using DEXA. Finally the extend of the expected micromovements between the polyethylene liner and the metal backing of the titanium plateau will be compared and taken into account with the results.

Tibia wedge stems are exposed to the greatest load test by shearing forces while block stems are bearing the greater load with compression and some scientists therefore speculate that block-designs are better than wedge-designs. This project is set up to explain the theoretical speculations about design and implant survival. The durability of the implants have been tested in account of fatigue and durability in a 80-20 test and they're both able to resist 4-6 times bodyweight. Furthermore, the polyethylene is produced by direct compression molding making it very resistant to wear.

To evaluate both the implant-bone micromotions and the polyethylene-implant micromovements metal markers have been placed on the implant prior to surgery and furthermore into the tibial bone and into the tibial polyethylene intra-operatively allowing us to evaluate stereo x-rays by a photogrammetric computer analyses called RSA at the Orthopaedic Center, Aarhus University Hospital. Follow-up stereo x-rays will be scheduled for 1 week, 3 months, 6 month, 1 years and 2 years post-surgery. Periprostetic bone density will be evaluated at 1 week, 1 year and 2 years upon inclusion at the Orthopaedic Center, Aarhus University Hospital.

02

Conditions studied

  • Osteoarthritis

Browse trials for

Keywords

  • RSA
  • DEXA
  • Gonarthrosis
  • Knee Arthroplasty
  • Micromotion of polyethylen liner
  • Stem arthroplasty design
03

In context

Osteoarthritis

4,398 studies on the registry are indexed under Osteoarthritis; 582 are open to participants now.

This study's enrollment of 54 is below the median of 70 across 3,440 interventional studies indexed under Osteoarthritis.

Browse Osteoarthritis studies →

Lead sponsor

University of Aarhus is the lead sponsor of 1,274 studies on the registry; 183 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
70 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Patients with one- or double-sided primary knee arthrosis.
  • Patients with a sufficient bone quality for implantation of knee prosthesis.
  • Informed and written patient consent.

Exclusion criteria

Exclusion Criteria:

  • Patients with neuromuscular or vascular diseases in the affected leg.
  • Patients who peroperatively are estimated unsuitable for knee arthroplasty e.g. due to bone cysts or dilution of the bone mass.
  • Patients who use non-steroid anti-inflammatory drugs (NSAID) and cannot refrain from taking them postoperatively (this includes COX-2-inhibitors).
  • Patients with osteoporosis estimated from the preoperative x-ray or former diagnosis of osteoporosis.
  • Patients with knee arthrosis following fracture sequelae.
  • Women, who are pregnant or are at risk of getting pregnant throughout the 2 year follow-up.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
54 participants (actual)

Study arms

  • Active comparator
    I-beam

    I-beam stem design of tibial component for Total Knee Arthroplasty.

    Device: Maxim TKA

  • Active comparator
    wedge

    Wedge stem design of tibial component for Total Knee Arthroplasty.

    Device: Maxim TKA

Interventions

  • DeviceMaxim TKA

    Operation with Total Knee Arthroplasty and either an I-beam stem or a wedge stem of the tibial component.

    Also known as: Biomet Merck: Maxim TKA

06

What researchers measure

Primary outcomes

  1. Tibial component migration evaluated by RSA.

    Time frame: post-operative, three months, six months, one year, two years

  2. Periprosthetic bone changes evaluated by DEXA.

    Time frame: post-operative, one year, two years

Secondary outcomes

  1. Micromotion of the modular polyethylene liner in both type prostheses evaluated by RSA.

    Time frame: post-operative, three months, six months, one year, two years

07

Study locations

1 site
  • Orthopaedic Center, Aarhus University Hospital
    Aarhus, 8000, Denmark
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 4, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00175136
Lead sponsor
University of Aarhus
Collaborators
Aarhus University Hospital
Responsible party
Sponsor
First posted
Sep 15, 2005
Start date
Jan 2005
Primary completion
Oct 2009
Completion
Oct 2009
Last update
Jan 4, 2023

Study contacts

Kjeld Søballe, MD, Prof.
principal investigator · Orthopaedic Center, Aarhus University Hospital, Tage-Hansens Gade 2, 8000 Aarhus C, Denmark.

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2010. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion