CompletedNot Applicable

A Roentgen Stereophotogrammetric Analysis on Migration of Knee Prostheses.

Denmark50 participantsStarted 2003-11

Plain-language summary

The purpose of this study is to compare the early migration of two uncemented total knee arthroplasties with different metal coating. Only the tibial prosthesis plateau varies. One is made out of tantalum and has two short pegs for fixation into the tibia while the other is covered by titanium fiber-mesh on the bone-near site and has 4 short pegs for screw fixation into the tibia.

Who can participate

Age range18 Years – 70 Years

SexALL

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Inclusion criteria

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

Exclusion criteria

✕. Patients with neuromuscular or vascular diseases in the affected leg.
✕. Patients who peroperatively are estimated unsuitable for an uncemented 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 fracture sequelae.
✕. Women, who are pregnant or are at risk of getting pregnant.

What they're measuring

Polyethylene wear (mm) of the medial and lateral knee prosthesis compartments at 5 years followup measured with model-based radiostereometry

Timeframe: Up to 5 years

Trial details

NCT IDNCT00138853

SponsorUniversity of Aarhus

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2010-04

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