Osteolysis Development Around Uncemented Cups With or Without Screw Holes

Arthroplasty Complications Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03692351
• Other study ID #: Protesteam_Trilogy
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Arthroplasty Complications
• Osteolysis

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