Osteolysis Development Around Uncemented Cups With or Without Screw Holes

Sponsor

Sahlgrenska University Hospital, Sweden (Other)

Overall Status

Completed

CT.gov ID

NCT03692351

Collaborator

Zimmer Biomet (Industry)

Enrollment

Arms

270.6

Actual Duration (Months)

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Arthroplasty Complications	Device: Uncemented acetabular cup with screw holes Device: Uncemented acetabular cup without screw holes	N/A

Detailed 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.

Study Design

Study Type:

Interventional

Actual Enrollment :

95 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jun 15, 1994

Actual Primary Completion Date :

Dec 31, 2016

Actual Study Completion Date :

Dec 31, 2016

Arms and Interventions

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

Arm

Intervention/Treatment

Active Comparator: Cup with screw holes

Uncemented Trilogy cup (Zimmer, Warzaw, IN, US), screw fixation (2 or 3 screws)

Device: Uncemented acetabular cup with screw holes

Experimental: Cup without screw holes

Uncemented Trilogy cup (Zimmer, Warzaw, IN, US) without screw holes, press-fit fixation

Device: Uncemented acetabular cup without screw holes

Outcome Measures

Primary Outcome Measures

Periacetabular osteolysis frequency change between 7 and 18 years [Change between 7 to 18 years after surgery]
Frequency of osteolysis (%) measured with computed tomography
Periacetabular osteolysis size change between 7 and 18 years [Change between 7 to 18 years after surgery]
Size of periacetabular osteolysis (cm3) masured with computed tomography

Secondary Outcome Measures

Cup fixation (translation) [18 years postoperatively]
Cup translation (mm/year) measured with radiostereometry, calculated from multiple measurements during the study period
Cup fixation (rotation) [18 years postoperatively]
Cup rotation (degrees/year) measured with radiostereometry, calculated from multiple measurements during the study period
Polyethylene wear [18 years postoperatively]
Polyethylene wear (mm/year) measured with radiostereometry, calculated from multiple measurements during the study period

Eligibility Criteria

Criteria

Ages Eligible for Study:

30 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

primary or secondary osteoarthritis

Exclusion Criteria:

Inflammatory osteoarthritis, hip joint infection

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Sahlgrenska University Hospital, Sweden
Zimmer Biomet

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Per-Erik Johanson, Researcher, Sahlgrenska University Hospital, Sweden

ClinicalTrials.gov Identifier:

NCT03692351

Other Study ID Numbers:

Protesteam_Trilogy

First Posted:

Oct 2, 2018

Last Update Posted:

Oct 2, 2018

Last Verified:

Sep 1, 2018

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Yes

Product Manufactured in and Exported from the U.S.:

Yes

Keywords provided by Per-Erik Johanson, Researcher, Sahlgrenska University Hospital, Sweden

uncemented hip arthroplasty

osteolysis

polyethylene wear

implant design

Additional relevant MeSH terms:

Osteolysis

Study Results

No Results Posted as of Oct 2, 2018