Arthroplasty ComplicationsNCT03692351
Osteolysis Development Around Uncemented Cups With or Without Screw Holes
A study testing Uncemented acetabular cup with screw holes and Uncemented acetabular cup without screw holes in people with Arthroplasty Complications, run by Sahlgrenska University Hospital.
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. Read more about this study
- Who is it for?
- Ages 30 to 75 years
- Conditions the study is for
- Arthroplasty Complications
- What is being tested?
- Uncemented acetabular cup with screw holes and Uncemented acetabular cup without screw holes
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 95 participants
- Where
- No sites listed yet
- Study dates
- 15 Jun 1994to 31 Dec 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- primary or secondary osteoarthritis
Who cannot join
- Inflammatory osteoarthritis, hip joint infection
About this study
Official title: 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.
Read the 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.
- Conditions
- Arthroplasty Complications
- Being tested
- Uncemented acetabular cup with screw holes, Uncemented acetabular cup without screw holes
- Keywords
- uncemented hip arthroplasty, osteolysis, polyethylene wear, implant design
- Medical subject headings
- Osteolysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Uncemented acetabular cup with screw holesDevice
Uncemented acetabular cup without screw holesDevice
| Study group | Role | What they receive |
|---|---|---|
| Cup with screw holes | Active comparator | Uncemented Trilogy cup (Zimmer, Warzaw, IN, US), screw fixation (2 or 3 screws) Receives: Device: Uncemented acetabular cup with screw holes |
| Cup without screw holes | Experimental | Uncemented Trilogy cup (Zimmer, Warzaw, IN, US) without screw holes, press-fit fixation Receives: Device: Uncemented acetabular cup without screw holes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Periacetabular osteolysis frequency change between 7 and 18 years
Frequency of osteolysis (%) measured with computed tomography
Measured: Change between 7 to 18 years after surgery
Periacetabular osteolysis size change between 7 and 18 years
Size of periacetabular osteolysis (cm3) masured with computed tomography
Measured: Change between 7 to 18 years after surgery
Secondary outcomes (3)
Cup fixation (translation)
Cup translation (mm/year) measured with radiostereometry, calculated from multiple measurements during the study period
Measured: 18 years postoperatively
Cup fixation (rotation)
Cup rotation (degrees/year) measured with radiostereometry, calculated from multiple measurements during the study period
Measured: 18 years postoperatively
Polyethylene wear
Polyethylene wear (mm/year) measured with radiostereometry, calculated from multiple measurements during the study period
Measured: 18 years postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2018
- Study start15 Jun 1994
- Primary completion31 Dec 2016
- Study completion31 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arthroplasty ComplicationsStudies of the same condition, open and under way.
- More trials run by Sahlgrenska University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 95 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sahlgrenska University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Zimmer Biomet
- Responsible party
- Principal investigator, Per-Erik Johanson, Sahlgrenska University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03692351
- Sponsor's protocol ID
- Protesteam_Trilogy
- Status last verified
- Sep 2018
- First submitted
- 20 Aug 2018
- Last updated
- 2 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Osteolysis Development Over Time Around Uncemented Titanium Fiber Mesh Cups With or Without Screw Holes
- ClinicalTrials.gov ID
- NCT03692351
- Acronym / sponsor ID
- Protesteam_Trilogy
- Conditions
- Arthroplasty Complications
- Keywords
- uncemented hip arthroplasty, osteolysis, polyethylene wear, implant design
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 95 participants (actual)
- Lead sponsor
- Sahlgrenska University HospitalUniversity, hospital or other
- Collaborators
- Zimmer Biomet
- Study start
- 15 Jun 1994 (actual)
- Primary completion
- 31 Dec 2016 (actual)
- Study completion
- 31 Dec 2016 (actual)
- First posted
- 2 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cup with screw holes | Active comparator | Device: Uncemented acetabular cup with screw holesUncemented Trilogy cup (Zimmer, Warzaw, IN, US), screw fixation (2 or 3 screws) |
| Cup without screw holes | Experimental | Device: Uncemented acetabular cup without screw holesUncemented Trilogy cup (Zimmer, Warzaw, IN, US) without screw holes, press-fit fixation |
Who may qualify
- Ages
- 30 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- primary or secondary osteoarthritis
Key exclusion criteria (1 listed)
- Inflammatory osteoarthritis, hip joint infection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Uncemented acetabular cup with screw holes | Device | Cup with screw holes |
| Uncemented acetabular cup without screw holes | Device | Cup without screw holes |
Primary outcome
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
3 secondary outcomes
Cup fixation (translation)
Time frame: 18 years postoperatively
Cup fixation (rotation)
Time frame: 18 years postoperatively
Polyethylene wear
Time frame: 18 years postoperatively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Uncemented acetabular cup with screw holes and Uncemented acetabular cup without screw holes in people with Arthroplasty Complications, run by Sahlgrenska University Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Periacetabular osteolysis frequency change between 7 and 18 years (time frame: Change between 7 to 18 years after surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2018.