Arthroplasty ComplicationsNCT03692364
Evaluation of Metal-on-conventional-polyethylene vs Ceramic-on-ceramic Articulating Surfaces in Total Hip Arthroplasty
A study testing Ceramic-on-ceramic uncemented hip arthroplasty and Metal-on-polyethylene uncemented total hip arthroplasty in people with Arthroplasty Complications, run by Sahlgrenska University Hospital.
Trial summary
Polyethylene wear debris from metal-on-polyethylene articulations are one of the main causes of periprosthetic bone loss and non-infectious loosening in total hip arthroplasty. Ceramic articulations have a very low wear rate when measured in the laboratory and the investigator's hypothesis is that hip arthroplasty… Read more about this study
- Who is it for?
- Ages 35 to 64 years
- Conditions the study is for
- Arthroplasty Complications
- What is being tested?
- Ceramic-on-ceramic uncemented hip arthroplasty and Metal-on-polyethylene uncemented total hip arthroplasty
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- No sites listed yet
- Study dates
- 2 Oct 2003to 31 Dec 2022
- 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 35 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- primary osteoarthritis
- secondary osteoarthritis caused by idiopathic osteonecrosis, dysplasia or childhood disease (Mb Perthes, epiphysiolysis)
Who cannot join
- inflammatory arthritis
- hip joint infection
About this study
Official title: Randomized Evaluation of Metal-on-conventional-polyethylene vs Ceramic-on-ceramic Articulating Surfaces in Uncemented Total Hip Arthroplasty: A Radiostereometry Study Including 104 Patients
Polyethylene wear debris from metal-on-polyethylene articulations are one of the main causes of periprosthetic bone loss and non-infectious loosening in total hip arthroplasty. Ceramic articulations have a very low wear rate when measured in the laboratory and the investigator's hypothesis is that hip arthroplasty with an all ceramic articulation will have less osteolysis and wear in addition to equally good fixation and clinical outcome compared to the same hip arthroplasty design with a metal-on-polyethylene joint.
- Conditions
- Arthroplasty Complications
- Being tested
- Ceramic-on-ceramic uncemented hip arthroplasty, Metal-on-polyethylene uncemented total hip arthroplasty
- Keywords
- biomaterials, Implant wear, hip arthroplasty, osteolysis, aseptic loosening
- Medical subject headings
- Osteolysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ceramic-on-ceramic uncemented hip arthroplastyDevice
Metal-on-polyethylene uncemented total hip arthroplastyDevice
| Study group | Role | What they receive |
|---|---|---|
| Metal-on-conventional polyethylene | Active comparator | Uncemented hip arthroplasty (ABG-2, Stryker, Mahwah NJ, US) with a CoCr prosthetic femoral head and an acetabular liner made of intermedially cross-linked polyethylene polyethylene (Duration, Stryker, Mahwah, NJ, US). Receives: Device: Metal-on-polyethylene uncemented total hip arthroplasty |
| Ceramic-on-ceramic | Experimental | Uncemented hip arthroplasty (ABG-2, Stryker, Mahwah NJ, US) with a prosthetic femoral head and an acetabular liner made of alumina ceramic (Biolox Forte, Ceramtec, Plochingen, Germany). Receives: Device: Ceramic-on-ceramic uncemented hip arthroplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Osteolysis frequency change between 7 and 15 years
Osteolysis frequency (%) measured with computed tomography,
Measured: Change between 7 to 15 years after surgery
Osteolysis size change between 7 and 15 years
Osteolysis size (cm3) measured with computed tomography
Measured: Change between 7 and 15 years after surgery
Secondary outcomes (6)
Articulation wear at 7 years
Articulation wear as measured with radiostereometry, mm/year
Measured: At 7 years after surgery
Articulation wear at 15 years
Articulation wear as measured with radiostereometry, mm/year
Measured: 15 years after surgery
Implant fixation at 7 years
Stem and cup translation (mm/year) and rotation (degrees/year) measured with radiostereometry
Measured: 7 years after surgery
Implant fixation at 15 years
Stem and cup translation (mm/year) and rotation (degrees/year) measured with radiostereometry
Measured: At 15 years after surgery
Clinical function at 7 years
Harris Hip Score (0-100)
Measured: 7 years after surgery
Clinical function at 15 years
Harris Hip Score (0-100)
Measured: 15 years after surgery
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 start2 Oct 2003
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
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
- Model description
- Prospective randomized study
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sahlgrenska University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Stryker Nordic
- Responsible party
- Principal investigator, Per-Erik Johanson, Sahlgrenska University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03692364
- Sponsor's protocol ID
- Protesteam_ceram
- 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
- Randomized Evaluation of Metal-on-conventional-polyethylene vs Ceramic-on-ceramic Articulating Surfaces in Uncemented Total Hip Arthroplasty: A Radiostereometry Study Including 104 Patients
- ClinicalTrials.gov ID
- NCT03692364
- Acronym / sponsor ID
- Protesteam_ceram
- Conditions
- Arthroplasty Complications
- Keywords
- biomaterials, Implant wear, hip arthroplasty, osteolysis, aseptic loosening
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 104 participants (actual)
- Lead sponsor
- Sahlgrenska University HospitalUniversity, hospital or other
- Collaborators
- Stryker Nordic
- Study start
- 2 Oct 2003 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- 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.
Polyethylene wear debris from metal-on-polyethylene articulations are one of the main causes of periprosthetic bone loss and non-infectious loosening in total hip arthroplasty. Ceramic articulations have a very low wear rate when measured in the laboratory and the investigator's hypothesis is that hip arthroplasty with an all ceramic articulation will have less osteolysis and wear in addition to equally good fixation and clinical outcome compared to the same hip arthroplasty design with a metal-on-polyethylene joint.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Prospective randomized study
| Arm | Type | Receives |
|---|---|---|
| Metal-on-conventional polyethylene | Active comparator | Device: Metal-on-polyethylene uncemented total hip arthroplastyUncemented hip arthroplasty (ABG-2, Stryker, Mahwah NJ, US) with a CoCr prosthetic femoral head and an acetabular liner made of intermedially cross-linked polyethylene polyethylene (Duration, Stryker, Mahwah, NJ, US). |
| Ceramic-on-ceramic | Experimental | Device: Ceramic-on-ceramic uncemented hip arthroplastyUncemented hip arthroplasty (ABG-2, Stryker, Mahwah NJ, US) with a prosthetic femoral head and an acetabular liner made of alumina ceramic (Biolox Forte, Ceramtec, Plochingen, Germany). |
Who may qualify
- Ages
- 35 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- primary osteoarthritis
- secondary osteoarthritis caused by idiopathic osteonecrosis, dysplasia or childhood disease (Mb Perthes, epiphysiolysis)
Key exclusion criteria (2 listed)
- inflammatory arthritis
- 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 |
|---|---|---|
| Ceramic-on-ceramic uncemented hip arthroplasty | Device | Ceramic-on-ceramic |
| Metal-on-polyethylene uncemented total hip arthroplasty | Device | Metal-on-conventional polyethylene |
Primary outcome
Osteolysis frequency change between 7 and 15 years
Time frame: Change between 7 to 15 years after surgery
Osteolysis frequency (%) measured with computed tomography,
Osteolysis size change between 7 and 15 years
Time frame: Change between 7 and 15 years after surgery
Osteolysis size (cm3) measured with computed tomography
6 secondary outcomes
Articulation wear at 7 years
Time frame: At 7 years after surgery
Articulation wear at 15 years
Time frame: 15 years after surgery
Implant fixation at 7 years
Time frame: 7 years after surgery
Implant fixation at 15 years
Time frame: At 15 years after surgery
Clinical function at 7 years
Time frame: 7 years after surgery
Clinical function at 15 years
Time frame: 15 years after surgery
Results and safety
Results are not available in the source record.
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 Ceramic-on-ceramic uncemented hip arthroplasty and Metal-on-polyethylene uncemented total hip arthroplasty 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 2 inclusion and 2 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: status not confirmed, 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?
Results are not available in the source record.
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?
Osteolysis frequency change between 7 and 15 years (time frame: Change between 7 to 15 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.