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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03692351
Other study ID # Protesteam_Trilogy
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 15, 1994
Est. completion date December 31, 2016

Study information

Verified date September 2018
Source Sahlgrenska University Hospital, Sweden
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 95
Est. completion date December 31, 2016
Est. primary completion date December 31, 2016
Accepts healthy volunteers No
Gender All
Age group 30 Years to 75 Years
Eligibility Inclusion Criteria:

- primary or secondary osteoarthritis

Exclusion Criteria:

- Inflammatory osteoarthritis, hip joint infection

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Uncemented acetabular cup with screw holes

Uncemented acetabular cup without screw holes


Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
Sahlgrenska University Hospital, Sweden Zimmer Biomet

Outcome

Type Measure Description Time frame Safety issue
Primary Periacetabular osteolysis frequency change between 7 and 18 years Frequency of osteolysis (%) measured with computed tomography Change between 7 to 18 years after surgery
Primary Periacetabular osteolysis size change between 7 and 18 years Size of periacetabular osteolysis (cm3) masured with computed tomography Change between 7 to 18 years after surgery
Secondary Cup fixation (translation) Cup translation (mm/year) measured with radiostereometry, calculated from multiple measurements during the study period 18 years postoperatively
Secondary Cup fixation (rotation) Cup rotation (degrees/year) measured with radiostereometry, calculated from multiple measurements during the study period 18 years postoperatively
Secondary Polyethylene wear Polyethylene wear (mm/year) measured with radiostereometry, calculated from multiple measurements during the study period 18 years postoperatively
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