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Completed

NCT Number: NCT03692351

Osteolysis Development Around Uncemented Cups With or Without Screw Holes

In order to investigate the role of acetabular cup screw holes for the transport of osteolysis-inducing particles in a total hip arthroplasty articulation, the investigators compare the amount of bone loss around acetabular cups with and without holes. Bone loss is measured with computed tomography at 7 years and 15 - 18 years of follow-up.

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Key information

Age range

30 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

Particles generated by wear and corrosion within an artificial hip articulation can cause biologically mediated bone loss in the surrounding pelvis. Particles can be found within immunologically active cells inside bone lesions. Holes intended for screw fixation in uncemented acetabular cups are believed to be a main route for these particles from the articulation into the pelvic bone. Using pressfit, screws are not always necessary for a successful fixation of an uncemented cup. The investigator's hypothesis is that a pressfit fixated cup without screw holes will display a decreased amount of periacetabular osteolysis compared to a cup with screw holes. Therefore, 95 hips (90 patients) were randomized to receive either pressfit cups without screw holes or the same type of cup with screw holes. The occurence and size of periacetabular osteolysis will be compared between the two groups. In addition, since the patients will have a computed tomography examination at 7 years and between 15 and 18 years the investigator will also analyze development of periacetabular osteolysis over time. The different cups were paired with three different types of femoral stems. Also, articulation wear and cup and stem fixation will be analyzed using radiostereometry.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • primary or secondary osteoarthritis

Exclusion criteria

  • Inflammatory osteoarthritis, hip joint infection

Treatment and study plan

Uncemented acetabular cup with screw holes

Device

Uncemented acetabular cup without screw holes

Device

Primary outcomes

  1. Periacetabular osteolysis frequency change between 7 and 18 years

    Time frame: Change between 7 to 18 years after surgery

    Frequency of osteolysis (%) measured with computed tomography

  2. Periacetabular osteolysis size change between 7 and 18 years

    Time frame: Change between 7 to 18 years after surgery

    Size of periacetabular osteolysis (cm3) masured with computed tomography

Secondary outcomes

  1. Cup fixation (translation)

    Time frame: 18 years postoperatively

    Cup translation (mm/year) measured with radiostereometry, calculated from multiple measurements during the study period

  2. Cup fixation (rotation)

    Time frame: 18 years postoperatively

    Cup rotation (degrees/year) measured with radiostereometry, calculated from multiple measurements during the study period

  3. Polyethylene wear

    Time frame: 18 years postoperatively

    Polyethylene wear (mm/year) measured with radiostereometry, calculated from multiple measurements during the study period

Sponsors and collaborators

Lead sponsor

Sahlgrenska University Hospital

Other

Collaborators

  • Zimmer Biomet

Registry information

Official study title

Osteolysis Development Over Time Around Uncemented Titanium Fiber Mesh Cups With or Without Screw Holes

Important dates

Study start
1994
Primary completion
2016
Study completion
2016
First posted
Oct 2, 2018
Registry last updated
Oct 2, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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