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
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.
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.
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 →University of Aarhus is the lead sponsor of 1,274 studies on the registry; 183 are open to participants now.
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Exclusion Criteria:
I-beam stem design of tibial component for Total Knee Arthroplasty.
Device: Maxim TKA
Wedge stem design of tibial component for Total Knee Arthroplasty.
Device: Maxim 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
Tibial component migration evaluated by RSA.
Time frame: post-operative, three months, six months, one year, two years
Periprosthetic bone changes evaluated by DEXA.
Time frame: post-operative, one year, two years
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
This study is completed, as verified in Oct 2010. You cannot join it, but the record below documents what was studied.
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University of Aarhus