NCT Number: NCT03692351
Osteolysis Development Around Uncemented 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.
Looking for future studies?
Notify MeKey information
Conditions
Age range
30 year–75 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
About this study
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.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- primary or secondary osteoarthritis
Exclusion criteria
- Inflammatory osteoarthritis, hip joint infection
Treatment and study plan
Uncemented acetabular cup without screw holes
DevicePrimary outcomes
-
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
-
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
Secondary outcomes
-
Cup fixation (translation)
Time frame: 18 years postoperatively
Cup translation (mm/year) measured with radiostereometry, calculated from multiple measurements during the study period
-
Cup fixation (rotation)
Time frame: 18 years postoperatively
Cup rotation (degrees/year) measured with radiostereometry, calculated from multiple measurements during the study period
-
Polyethylene wear
Time frame: 18 years postoperatively
Polyethylene wear (mm/year) measured with radiostereometry, calculated from multiple measurements during the study period
Sponsors and collaborators
Lead sponsor
Sahlgrenska University Hospital
Other
Collaborators
- Zimmer Biomet
Registry information
Official study title
Osteolysis Development Over Time Around Uncemented Titanium Fiber Mesh Cups With or Without Screw Holes
Important dates
- Study start
- 1994
- Primary completion
- 2016
- Study completion
- 2016
- First posted
- Oct 2, 2018
- Registry last updated
- Oct 2, 2018
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Related clinical trials
Published trials that share one or more normalized conditions with this study.
Plasmafit® Revision Structan® Hip Endoprosthesis Cup
NCT04255966
Arthritis, Arthroplasty Complications
Würzburg, Bavaria, Germany
View Trial DetailsTotal Hip Arthoplastry Revision by Dual-mobility Acetabular Cup Cemented in a Metal Reinforcement
NCT03680443
Arthroplasty Complications, Aseptic Loosening
Amiens, France
View Trial DetailsTotal Knee Arthroplasty With the Medial-Pivot Knee System
NCT03677518
Arthroplasty Complications
Amiens, France
View Trial DetailsThe Efficiency of Periarticular Multimodal Drug Injection in Pain Management Following Primary Unilateral TKA
NCT06112548
Arthritis, Arthritis Knee
Damascus, Syria
View Trial Details