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Osteolysis Development Around Uncemented Cups With or Without Screw Holes

S

Sahlgrenska University Hospital

Status

Completed

Conditions

Arthroplasty Complications

Treatments

Device: Uncemented acetabular cup without screw holes
Device: Uncemented acetabular cup with screw holes

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT03692351
Protesteam_Trilogy

Details and patient eligibility

About

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.

Full description

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.

Enrollment

95 patients

Sex

All

Ages

30 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • primary or secondary osteoarthritis

Exclusion criteria

  • Inflammatory osteoarthritis, hip joint infection

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

95 participants in 2 patient groups

Cup with screw holes
Active Comparator group
Description:
Uncemented Trilogy cup (Zimmer, Warzaw, IN, US), screw fixation (2 or 3 screws)
Treatment:
Device: Uncemented acetabular cup with screw holes
Cup without screw holes
Experimental group
Description:
Uncemented Trilogy cup (Zimmer, Warzaw, IN, US) without screw holes, press-fit fixation
Treatment:
Device: Uncemented acetabular cup without screw holes

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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