Osteolysis Development Around Uncemented Cups With or Without Screw Holes
September 30, 2018 updated by: Per-Erik Johanson, Sahlgrenska University Hospital, Sweden
Osteolysis Development Over Time Around Uncemented Titanium Fiber Mesh 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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
95
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
26 years to 71 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- primary or secondary osteoarthritis
Exclusion Criteria:
- Inflammatory osteoarthritis, hip joint infection
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Cup with screw holes
Uncemented Trilogy cup (Zimmer, Warzaw, IN, US), screw fixation (2 or 3 screws)
|
|
|
Experimental: Cup without screw holes
Uncemented Trilogy cup (Zimmer, Warzaw, IN, US) without screw holes, press-fit fixation
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
Change between 7 to 18 years after surgery
|
|
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
|
Change between 7 to 18 years after surgery
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Cup fixation (translation)
Time Frame: 18 years postoperatively
|
Cup translation (mm/year) measured with radiostereometry, calculated from multiple measurements during the study period
|
18 years postoperatively
|
|
Cup fixation (rotation)
Time Frame: 18 years postoperatively
|
Cup rotation (degrees/year) measured with radiostereometry, calculated from multiple measurements during the study period
|
18 years postoperatively
|
|
Polyethylene wear
Time Frame: 18 years postoperatively
|
Polyethylene wear (mm/year) measured with radiostereometry, calculated from multiple measurements during the study period
|
18 years postoperatively
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 15, 1994
Primary Completion (Actual)
December 31, 2016
Study Completion (Actual)
December 31, 2016
Study Registration Dates
First Submitted
August 20, 2018
First Submitted That Met QC Criteria
September 30, 2018
First Posted (Actual)
October 2, 2018
Study Record Updates
Last Update Posted (Actual)
October 2, 2018
Last Update Submitted That Met QC Criteria
September 30, 2018
Last Verified
September 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Protesteam_Trilogy
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
Yes
product manufactured in and exported from the U.S.
Yes
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.